Pridopidine - Prilenia Therapeutics
Alternative Names: ACR-16; ASP-2314; FR-310826; Huntexil; TV-7820Latest Information Update: 18 Apr 2024
At a glance
- Originator NeuroSearch Sweden AB
- Developer Massachusetts General Hospital; Prilenia Therapeutics; Teva Pharmaceutical Industries
- Class Antidementias; Antiparkinsonians; Antipsychotics; Eye disorder therapies; Neuropsychotherapeutics; Piperidines; Small molecules; Sulfones
- Mechanism of Action Dopamine D2 receptor antagonists; Glutamate modulators; Sigma-1 receptor agonists
-
Orphan Drug Status
Yes - Amyotrophic lateral sclerosis; Huntington's disease
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Phase III Huntington's disease
- Phase II/III Amyotrophic lateral sclerosis
- Phase II Parkinson's disease
- No development reported Alzheimer's disease; Eye disorders; Fragile X syndrome; Rett syndrome
- Discontinued Schizophrenia
Most Recent Events
- 12 Apr 2024 Prilenia Therapeutics plans to submit Marketing Authorization Application for Huntington’s disease in the EU in mid-2024
- 12 Mar 2024 Prilenia Therapeutics plans to submit global regulatory submissions for additional countries for Huntington’s disease
- 19 Jan 2024 Efficacy and adverse events data from phase II/III HEALEY ALS platform trial in Amyotrophic lateral sclerosis released by Prilenia Therapeutics
Development Overview
Introduction
Pridopidine is an orally available small molecule, dopidine or dopaminergic stabiliser, being developed by Prilenia Therapeutics for the treatment of Alzheimer's disease, amyotrophic lateral sclerosis (ALS), neurodegenerative eye disorders, fragile X syndrome, Parkinson's disease and Rett syndrome. Pridopidine acts to either enhance or inhibit dopamine dependent functions in the brain, depending on the initial level of dopaminergic activity. It inhibits dopamine activation of the D2 receptor and has a higher affinity for this receptor when dopamine is already bound to the receptor (activated receptor). It has no detectable agonist activity at this receptor. Pridopidine strengthens glutamate function in the frontal cortex. It has also been demonstrated that pridopine is a potent agonist of the Sigma 1 receptor (S1R). S1R plays a key role in neuroprotection through increased production of brain-derived neurotrophic factor (BDNF), levels of which are reduced in neurodegenerative disorders. Clinical development is underway in multiple countries. Preclinical development is underway in Israel.
Pridopidine was originated by Carlsson Research (later NeuroSearch Sweden AB). Development in schizophrenia have been discontinued.
In September 2018, Teva Pharmaceutical sold and transferred it's rights pertaining to pridopidine to Prilenia Therapeutics. Earlier in October 2012, Teva Pharmaceutical had acquired all rights, assets and obligations of pridopidine from NeuroSearch [1] [2] [3] [4] .
As at October 2022, no recent reports of development had been identified for phase-I development in Amyotrophic-lateral-sclerosis in Israel (PO).
As at October 2023, no recent reports of development had been identified for preclinical development in Alzheimer's-disease in Israel (PO), preclinical development in Eye-disorders in Israel (PO), preclinical development in Fragile-X-syndrome in Israel (PO), preclinical development in Rett syndrome in Israel (PO).
Company Agreements
In May 2018, NeuroSearch and Teva Pharmaceutical Industries entered into an agreement to release Teva from all outstanding obligations pursuant to the agreement entered in 2012 concerning the transfer of NeuroSearch's rights in and to Pridopidine. According to the revised agreement, in the event that Teva, prior to 31 October 2018, enters into an agreement with an identified third party relating to the sale and transfer of Teva's rights in and to Pridopidine, then NeuroSearch will receive a cash payment of $US 450 000. Teva completed this agreement with effect from September 9, 2018, and accordingly, NeuroSearch received a cash payment of $US4 50 000. In October 2012, NeuroSearch and Teva Pharmaceutical Industries had closed an asset transfer agreement, whereby NeuroSearch sold pridopidine (Huntexil®) to Teva for a cash purchase price of DKK149.5 million ($US26 million). NeuroSearch is eligible to potential regulatory and commercialisation milestone payments totalling up to DKK55.1 million (approximately $US10 million). Under the terms of the agreement, Teva purchased all rights, assets and obligations relating to pridopidine, including all obligations to the sellers of Carlsson Research. NeuroSearch had received an initial cash payment of DKK120.8 million, followed by an escrow, in April 2013, of DKK28.7 million at the final asset transfer of pridopidine to Teva.
This Deal Value was converted from DKK at a rate of $US 0.1731 on 28 September 2012. [3] [5] [4] [6] [7] [8] [2]
NeuroSearch (formerly Carlsson Research AB) had previously licensed pridopidine to Fujisawa (later Astellas), who evaluated the product in early clinical development for the treatment of schizophrenia. Based on the commercial and developmental challenges in this indication, Astellas decided to discontinue development of pridopidine and returned all territorial and commercialisation rights of the compound to NeuroSearch in March 2009 [9] [10] .
Carlsson Research was renamed as NeuroSearch Sweden AB in October 2006, after it was acquired by NeuroSearch A/S [11] [12] .
Key Development Milestones
As of September 2020, Prilenia Therapeutics plans to submit marketing authorisation applications and subsequently commercialise pridopidine [13] .
Amyotrophic lateral sclerosis
In July 2021, Prilenia Therapeutics announced that the US FDA has granted Orphan Drug Designation for pridopidine for the treatment of amyotrophic lateral sclerosis (ALS) [14] .
Pridopidine was also received Orphan Drug Designation for ALS in the Europe [15] .
In June 2021, Prilenia Therapeutics received a positive opinion on European Orphan Drug Designation for pridopidine in Amyotrophic lateral sclerosis (ALS), from the EMA Committee for Orphan Medicinal Products (COMP). The orphan drug designation is expected to be granted within 30 days, following the positive opinion issued by COMP [16] .
In October 2023, Prilenia in collaboration with Massachusetts General Hospital, National Institute of Neurological Disorders and Stroke (NINDS) and National Institutes of Health (NIH) initiated a expanded access protocol (EAP) for Pridopidine in People With amyotrophic lateral sclerosis (Pridopidine EAP 2; EAP 2; PL101ALS501; NCT06069934). This study intends to enrol 200 participants [17] .
As of January 2024, Prilenia Therapeutics plans the phase-III pivotal trial for Amyotrophic lateral sclerosis in the H2 2024 [18] .
In July 2022, Prilenia Therapeutics, in collaboration with Massachusetts General Hospital, completed the phase II/III HEALEY ALS platform trial which was designed to investigate the safety and efficacy of pridopidine, compared with placebo, in patients with amyotrophic lateral sclerosis (ALS) (NCT04615923; 2019P003518D). The primary objective of the trial is to measure change in disease severity over time as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R). The randomised, perpetual multi-regimen trial was initiated in December 2020 and enrolled 163 patients in the US, in January 2022. Earlier, in January 2021, Prilenia Therapeutics announced the enrolment of the first ALS patient in the master protocol trial [15] [19] [20] . In February 2023, data from the trial was released which demonstrated slowing of decline of voice characteristics in adults taking pridopidine versus adults taking placebo. It also demonstrated that pridopidine preserves speech and bulbar function in patients [21] . Company released additional safety and efficacy data [18] .
In July 2020, Massachusetts General Hospital initiated a phase II/II HEALEY ALS platform trial to evaluate safety and efficacy of Pridopidine (the regimen D part of the HEALEY ALS Platform Trial Master Protocol) for the treatment of patients with amyotrophic lateral sclerosis (NCT04297683; 2019P003518). This ramdomised trial is designed to enrol approximately 800 patients in the US [22] . In February 2023, the company released the efficacy and safety data from the trial. The company announced that pridopidine did not meet the primary endpoint of change from baseline to week 24 in the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R), there were consistent, positive trends observed among participants receiving pridopidine across several pre-specified secondary and exploratory measures [23] .
As of September 2019, pridopidine is in phase I development for the treatment of amyotrophic lateral sclerosis. Preclinical studies stated that, pridopidine exerted neuroprotective effects via activation of the S1R, in ALS SOD1G93A motor neurons. Treatment with pridopidine improved the brain-derived neurotrophic factor (BDNF) and glial cell line-derived neurotrophic factor (GDNF) axonal transport. Pridopidine restored synaptic activity and the neuro-muscular junction (NMJ) function by increasing the neuronal survival. In in-vivo studies, pridopidine treatment of SOD1G93A mice reduced the toxic protein aggregates and ameliorated muscle fiber wasting (Prilenia Therapeutics pipeline, September 2019) [24] .
Parkinson's disease
In November 2020, Prilenia Therapeutics terminated a phase II trial that assessed the efficacy and safety of two doses of pridopidine versus placebo for the treatment of levodopa-induced dyskinesia in patients with Parkinson's disease (gLIDe) (NCT03922711; PL101-LID201). The trial was terminated due to COVID-19 pandemic. The double-blind, randomised trial was initiated in March 2019 and enrolled 23 patients in the US [25] .
Carlsson Research completed phase Ia and Ib trials in Parkinson's disease, with favourable results.
As of September 2019, pridopidine is in preclincial development for Alzheimer's disease, neurodegenerative eye disorders, fragile X syndrome and Rett syndrome (Prilenia Therapeutics pipeline, September 2019).
Huntington's disease (HD)
In April 2024, Prilenia Therapeutics announces intention of regulatory submission for Huntington’s Disease in mid 2024 [26] .
In November 2021, Prilenia Therapeutics announced that the US FDA has granted Fast Track designation to pridopidine for development as a potential treatment for Huntington’s Disease (HD) [27] .
In March 2024, Prilenia Therapeutics announced the intentions to submit a Marketing Authorization Application (MAA) for pridopidine for the treatment of Huntington’s disease (HD) to the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in mid-2024. This decision follows positive pre-submission meetings with regulatory authorities in the European Union. The Company will also consider global regulatory submissions for additional countries and regions following the regulatory review process in Europe [28] .
As of March 2023, Prilenia Therapeutics completed the phase III PROOF-HD trial that evaluated the efficacy and safety of pridopidine 45mg bid in patients with early stage Huntington's Disease (HD), however it didn't meet the primary endpoint which was change from baseline in the Unified Huntington Disease Rating Scale-Total functional capacity (UHDRS-TFC) score within a baseline of 65 weeks (PL101-HD301; EudraCT2020-002822-10; NCT04556656). This randomised, double-blind, placebo-controlled trial was initiated in October 2020 and enrolled 499 patients aged 25 or older with a clinical diagnosis of adult-onset HD in the US, Germany, Austria, France, Canada, Czech Republic, Italy, Poland, Spain, Netherlands, and the UK [29] . The first patients in the US were enrolled in October 2020. In January 2021, Prelenia announced the enrolment of the first participant in Europe. The company also announced that national approval has been granted in all European countries [30] [31] [32] . In October 2021, the company announced that patient enrollment has been completed in the study [33] [34] [35] [32] . In July, 2022, an independent safety monitoring committee (SMC) reviewed all unblinded safety data and concluded that no safety signals of concern emerged. SMC recommended continuation of PROOF without modification. As of January 2023, the company reported that low dropout (42/499, 8.4%) was consistent with pridopidine’s favorable tolerability and safety profile [36] . In April 2023, efficacy and averse events data from the trial were presented at the 75th Annual Meeting of the American Academy of Neurology (AAN-2023) [37] .
In May 2018, Teva discontinued development of pridipidine for the treatment of Huntington's disease following the failure to meet its primary endpoints in a phase II trial (see below) [8] .
In October 2012, Teva purchased all rights to pridopidine and intends to design and complete new clinical studies for the symptomatic relief of HD [4] [3] [38] .
Teva Pharmaceutical Industries reported in its third quarter presentation (filed in October 2014) that it expects to submit NDA application of pridopidine to the US FDA by 2016.
In March 2011, NeuroSearch held an End of Phase II meeting with the US FDA, during which, the authority concluded that confirmatory clinical data, including a confirmatory phase III programme, would be required for a submission for marketing authorisation in the US. A similar response was received from the EMA in May 2011. The feedback from the US and the EU regulatory authorities was based on data from the phase IIb/III HART and phase III MermaiHD clinical trials, in which the primary endpoint of modified Motor Score (mMS), a subscale of the Unified Huntington's Disease Rating Scale (UHDRS), was not met. However, a significant effect on Total Motor Score (TMS) was observed. The FDA requested additional phase III data to support the observed effect of pridopidine on the TMS and the clinical relevance of this finding. The FDA also recommended investigating doses of pridopidine higher than those used in the two trials [39] [40] [41] . Based on the feedback, NeuroSearch had designed a development programme, which included the multinational, placebo-controlled, phase III Prime-HD trial of 45mg or 67.5mg doses of pridopidine, and additional complementary studies to support registration [42] [43] [44] [45] [46] [47] [48] .
The primary endpoint was not met in a phase III MermaiHD trial that evaluated of the safety and efficacy of pridopidine in patients with HD (ACR16 C008; NCT00665223) [38] . The primary endpoint of mMS assessed the effect of pridopidine on voluntary motor function at week 26, which included measurement of parkinsonism, gait/balance, hand functionality and bradykinesia. Initial top-line results had indicated the primary endpoint had been met; however, the analysis had included the clinically relevant CAGn adjustment, which is made to correct for differences in patients' genetic background [49] [50] . A further analysis without adjustment for CAGn showed that the prespecified statistical significance level for the primary endpoint had not been met. The EHDN issued a supportive statement on the conclusions regarding the primary endpoint, following an independent EHDN panel review of the statistical data and the analyses performed [51] . A total of 437 patients were randomised to receive 45mg pridopidine (once- or twice-daily) or placebo in the MermaiHD trial. the trial was conducted by NeuroSearch and the European Huntington's Disease Network (EHDN). An open-label extension of the study (MermaiHD Extension) was completed by 305 patients who received pridopidine (45mg twice-daily) over 26 weeks. Results from the extension trial have been reported, which show that pridopidine was well tolerated for a total of 12 months [52] [53] [54] [55] .
In Europe, 130 patients from the MermaiHD study continued to receive pridopidine in a compassionate use programme [44] [56] .
The 3-month, randomised, placebo-controlled, phase IIb/III HART trial of pridopidine in patients with HD was completed in June 2011 in the US and Canada(NCT00724048) [38] . The trial was conducted in collaboration with the Huntington Study Group [57] . The trial enrolled 227 patients and three different doses of pridopidine (10, 22.5, and 45mg) were evaluated. In this trial, similar to the MermaiHD trial, the primary endpoint of mMS was not met, although results showed a significant effect on TMS after 12 weeks of treatment [58] [59] [60] . Teva is conducting a phase II extension trial of pridopidine in patients with HD in the US and Canada (OPEN-HART; NCT01306929). The trial is assessing the safety of 45mg pridopidine and the TMS in 118 enrolled patients during long-term, open-label administration. In April 2017, interim data from the trial were presented at the 69th Annual Meeting of the American Academy of Neurology (AAN-2017) [61] [62] [53] [63] .
Teva completed the phase II Pride-HD study in August 2016 (Pride-HD; NCT02006472; EudraCT2013-001888-23). The company had initiated the randomised, double-blind, placebo-controlled trial in February 2014, to assess the efficacy and safety of varying doses of pridopidine capsules in treating motor impairment in patients with HD, and enrolled 408 patients in the US, Australia, Austria, Canada, Denmark, France, Germany, Italy, Poland, Russia, the UK and the Netherlands. The trial was initially designed for a duration of 26 weeks but due to the discovery of pridopidine's previously unknown mode of action as a potent agonist of the Sigma 1 Receptor (S1R) resulted in a change in PRIDE-HD study design, from a 26-week study focused on symptoms, to a 52-week study focused on exploring pridopidine’s potential impact on disease progression, as measured by Total Functional Capacity (TFC). Topline data released by the company demonstrated a statistically significant impact on the endpoint of disease progression at 52 weeks following treatment with pridopidine at certain doses versus placebo, as measured by TFC. In April 2017, efficacy data were presented at the 69th Annual Meeting of the American Academy of Neurology (AAN-2017). The study did not reveal new safety or tolerability concerns [64] [65] [66] [67] .
In January 2018, Teva terminated the phase II Open PRIDE-HD trial as the study served its purpose in providing considerable safety data (TV7820-CNS-20016; EudraCT2015-000904-24; NCT02494778). The decision was not based on any new or emerging safety concern. The trial was initiated in September 2015 to evaluate the long term safety and efficacy of pridopidine in patients with Huntington's disease, who have completed the Pride-HD study within the last 6 months, including a follow-up period of 2 weeks. The open-label trial enrolled 248 patients, by invitation only, in the US, Australia, Austria, Canada, Russia, the Netherlands, France, Germany, Italy, Poland and in the UK [68] .
NeuroSearch completed a multiple-ascending dose (MAD) study of pridopidine in May 2012. The study, involving 36 healthy volunteers, evaluated the tolerability of pridopidine in doses ≥ 45mg to determine the supra-therapeutic dose for a thorough QT heart study in volunteers. The maximum tolerated dose was determined to be 90mg twice daily [42] [69] .
Pridopidine has completed several phase I/II trials for HD. The US FDA and the EMEA granted orphan drug status to pridopidine for HD in January 2006 and June 2005, respectively [70] [71] .
In January 2018, Teva Branded Pharmaceutical Products R&D completed a phase I trial that evaluated sigma-1 and dopamine-2 receptor occupancy by pridopidine in the human brain of healthy volunteers and in patients With Huntington's disease (TV7820-IMG-10082; EudraCT2016-001757-41; NCT03019289). The open-label, single-group trial was initiated in March 2017 and enrolled 38 participants in Germany [72] .
In-vitro
studies showed pridopidine stabilising medium spiny neurons and brain-derived neurotrophic factor secretion in a S1R-dependent fashion, which suggested activity of pridopidine’s potential beyond improving motor symptoms [64] .
Other indications
Astellas Pharma began dosing the first patients with schizophrenia in a placebo-controlled, multiple-dose phase Ib trial in April 2007. The study was enrolling up to 60 patients in the US. However development in this indication has been discontinued [9] [73] [10] [74] .
Financing information
In April 2022, Prilenia Therapeutics raised an additional $10 million. The proceeds will be used to continue the strong momentum of its lead drug candidate, pridopidine, for patients with Huntington’s Disease (HD) and Amyotrophic Lateral Sclerosis (ALS) through 2024 [75] .
In November 2021, Prilenia Therapeutics raised $US43 million in an oversubscribed Series B financing round. The proceeds will be used to prepare for potential registration and commercialisation of pridopidine for patients with Huntington’s Disease (HD) and Amyotrophic Lateral Sclerosis (ALS), and to accelerate timelines and expand the Company’s executive team and operations. The Series B financing brings the total capital invested in Prilenia Therapeutics since its founding in September 2018 to $US133.5 million [76] .
Prilenia Therapeutics, in June 2020, raised $US62.5 million in a Series A financing round led by Forbion, Morningside Venture Investments and Sectoral Asset Management. The proceeds from this offering will be used to launch Prilenia's registrational planned late-stage phase III clinical trials in Huntington's disease (HD) and Amyotrophic lateral sclerosis (ALS) [77]
Patent Information
In December 2018, Prilenia Therapeutics was granted patent number US 901 247 6B2 covering "hydrobromide salt of pridopidine" in the US [1] .
NeuroSearch was issued the composition-of-matter patent for pridopidine which expires in 2020.
In March 2010, NeuroSearch filed a patent application to cover pridopidine in the use of slowing Huntington's disease progression in addition to its symptomatic effects [78] .
The European Patent Office issued an European patent (No. EP 1240142) to Carlsson Research in April 2005 covering compounds for the treatment of psychiatric and neurological disorders. This patent originates from the company's PCT/WO01/46145 patent application, which has been filed in 25 countries, and has been issued in Australia and New Zealand [79] .
Drug Properties & Chemical Synopsis
- Route of administration PO
- Formulation Capsule, Tablet, unspecified
- Class Antidementias, Antiparkinsonians, Antipsychotics, Eye disorder therapies, Neuropsychotherapeutics, Piperidines, Small molecules, Sulfones
- Target Dopamine D2 receptor; Glutamate; Sigma-1 receptor
- Mechanism of Action Dopamine D2 receptor antagonists; Glutamate modulators; Sigma-1 receptor agonists
-
WHO ATC code
N04B-X (Other dopaminergic agents)
N05A (Antipsychotics)
N07X (Other Nervous System Drugs)
S01 (Ophthalmologicals)
-
EPhMRA code
N4 (Anti-Parkinson Drugs)
N5A (Antipsychotics)
N7X (All other CNS drugs)
S1 (Ophthalmologicals)
- Chemical name 4-[3-(Methylsulfonyl)phenyl]-1-propylpiperidin hydrochloride
- Molecular formula C15 H23 N O2 S
- SMILES C1=C(C=CC=C1C1CCN(CC1)CCC)S(C)(=O)=O
-
Chemical Structure
- CAS Registry Number 346688-38-8
Biomarkers Sourced From Trials
Biomarker
| Drug Name | Biomarker Name | Biomarker Function |
|---|---|---|
| Pridopidine - Prilenia Therapeutics | CYP2D6 | Eligibility Criteria |
| CYP2D7 | Eligibility Criteria | |
| Huntingtin protein (HTT) | Brief Title, Eligibility Criteria |
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| Alzheimer's disease | - | - | No development reported (Preclinical) | Israel | PO / unspecified | Prilenia Therapeutics | 28 Oct 2023 |
| Amyotrophic lateral sclerosis | - | - | Phase II/III | USA | PO / Capsule | Massachusetts General Hospital, Prilenia Therapeutics | 14 Jul 2020 |
| Amyotrophic lateral sclerosis | - | - | No development reported (I) | Israel | PO / unspecified | Prilenia Therapeutics | 28 Oct 2022 |
| Eye disorders | Neurodegenerative eye diseases | - | No development reported (Preclinical) | Israel | PO / unspecified | Prilenia Therapeutics | 28 Oct 2023 |
| Fragile X syndrome | - | - | No development reported (Preclinical) | Israel | PO / unspecified | Prilenia Therapeutics | 28 Oct 2023 |
| Huntington's disease | - | In adults, In the elderly | Phase III | Austria, Canada, Czech Republic, France, Germany, Italy, Netherlands, Poland, Spain, USA (fast track), United Kingdom | PO / Capsule | Prilenia Therapeutics | 21 Oct 2021 |
| Huntington's disease | - | - | Discontinued (III) | Austria, Belgium, France, Germany, Italy, Portugal, Spain, United Kingdom | PO / Tablet | Teva Pharmaceutical Industries | 16 May 2018 |
| Huntington's disease | - | - | Discontinued (II/III) | Canada, USA | PO / Tablet | Teva Pharmaceutical Industries | 16 May 2018 |
| Huntington's disease | - | - | Discontinued (II) | Australia, Austria, Canada, Denmark, France, Germany, Italy, Netherlands, Poland, Russia, USA, United Kingdom | PO / Capsule | Teva Pharmaceutical Industries | 16 May 2018 |
| Parkinson's disease | Levodopa induced dyskinesia (LID) in patients with Parkinson Disease | In adults, In the elderly | Phase II | USA | PO / Capsule | Prilenia Therapeutics | 26 Mar 2019 |
| Rett syndrome | - | - | No development reported (Preclinical) | Israel | PO / unspecified | Prilenia Therapeutics | 28 Oct 2023 |
| Schizophrenia | - | - | Discontinued (I) | Sweden | PO / unspecified | 02 Mar 2009 |
Priority Development Status
| Type | Region | Indication |
|---|---|---|
| Fast Track | USA | Huntington's disease |
Orphan Status
| Indication | Patient Segment | Country | Organisation | Event Date |
|---|---|---|---|---|
| Amyotrophic lateral sclerosis | - | USA | Prilenia Therapeutics | 12 Jul 2021 |
| Amyotrophic lateral sclerosis | - | Europe | Prilenia Therapeutics | 05 Jan 2022 |
| Huntington's disease | - | European Union | Teva Pharmaceutical Industries | 21 Jun 2005 |
| Huntington's disease | - | USA | Teva Pharmaceutical Industries | 13 Jan 2006 |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| NeuroSearch Sweden AB | Originator | Sweden |
| Prilenia Therapeutics | Owner | Israel |
| Massachusetts General Hospital | Collaborator | USA |
Brand Names
| Brand Name | Organisations | Indications | Countries |
|---|---|---|---|
| Huntexil | Teva Pharmaceutical Industries | Huntington's disease | - |
Scientific Summary
-
Adverse Events
Frequent:
Chorea
Occasional: Adjustment disorders; Bipolar disorders; Breast cancer; Depression; Diarrhoea; Dizziness; Fatigue; Headache; Insomnia; Nasopharyngitis; Nausea; Seizures; Suicidal ideation; Testicular disorders
Pharmacokinetics
Pridopidine antagonises dopamine-dependent D2 activation with fast-off kinetics and has no detectable agonist activity at the D2 receptor. These in vitro findings suggested that pridopidine could be active during the physiological effects of dopamine surges [86] .
Adverse Events
Huntington's disease
Phase III
pridopidine (45mg twice daily) had a similar adverse event profile to placebo during a randomised, double blind, placebo controlled, phase III trial (MermaiHD) involving 437 patients with Huntington's disease (NCT00665223). Overall approximately two thirds of patients reported adverse events, the most frequent of which were dizziness, Huntington's chorea, diarrhoea, nausea, nasopharyngitis, depression, fatigue and insomnia (3-9% of patients). These adverse events were distributed equally between treatment and control arms [82] [50] . Preliminary data from a 12-month safety extension of the MermaiHD trial showed that pridopidine was generally well tolerated based on assessments of vital signs, ECG parameters and adverse events. The most frequently reported adverse events were similar to those observed during the randomised phase of the study, with the exception of worsening of Huntington's chorea, which appeared to increase in frequency with longer duration of pridopidine treatment; the incidence of worsened chorea was 6.2% in patients treated for 6 months versus 12.5% in those treated for 12 months. There was no increase in the frequency of serious events over the 12 month period. The extension study included 353 patients who had completed the first 26 weeks of treatment with twice-daily pridopidine or placebo in the randomised part of the trial [54] .
Results from the phase III PROOF-HD study showed that pridopidine was well-tolerated with no serious treatment-related adverse events, with a safety and tolerability profile similar to placebo and consistent with previous clinical studies [37] [32]
Phase II
pridopidine was generally well tolerated in the randomised, phase II, double-blind, placebo-controlled HART trial involving 227 patients with Huntington's disease enrolled in the US and Canada. Treatment was discontinued due to adverse events for 7% of patients, and nine serious adverse events (recurrent breast cancer, suicidal ideation, depression, bipolar disorder, adjustment disorder, testicular torsion and three episodes of convulsions) were reported in six patients. No dose-dependent clinical patterns related to active treatment were observed. The most frequently reported adverse events across all treatment groups were falls, headache, diarrhoea and nausea with no apparent pattern related to active treatment. The adverse event findings were consistent with the observations in the MermaiHD study [58] .
In the phase II Pride-HD study, pridopidine was found to be generally well tolerated consistent with the safety profile seen in previous studies and compatible with continued development. No new safety findings were reported [65] [67] .
In a phase II trial of patients with Huntington's disease, pridopidine was well tolerated. In this study, 58 patients were randomised to receive pridopidine or placebo, for 4 weeks. No difference between the treatment groups was noted for the quality, frequency or severity of adverse events (AEs) [87] .
Parkinson's disease
In a phase II trial of patients with advanced Parkinson's disease, pridopidine was well tolerated. In this study, seven patients received pridopidine titrated in steps to 20, 50, 70 and 100 mg/day or the maximum tolerated dose over the first week. Treatment was administered once daily for 14 days. AEs were generally mild, transient and CNS-related, and included light-headedness [74] .
In volunteers
In a multiple-ascending dose (MAD) study, treatment with pridopidine was associated with a dose-dependent increase in the frequency, duration and severity of adverse events. The randomised, double-blind, placebo-controlled trial evaluated the tolerability of pridopidine at doses > 45mg in 36 healthy volunteers. The 45mg twice daily dose was well tolerated, however QT prolongation was higher than in previous large clinical studies. Both the 67.5mg and 90mg dose cohorts demonstrated higher levels of QT prolongation compared with placebo. Nausea, headache, dizziness and vomiting were reported as additional adverse effects, with psychiatric symptoms seen at the MTD of 90mg twice daily [42] .
Result from a phase II/III HEALEY ALS platform trial showed that the pridopidine was well-tolerated and safe [23] [22] .
Amyotrophic lateral sclerosis
Pridopidine was well-tolerated with no serious treatment-related adverse events in phase II/III HEALEY ALS platform trial. Safety and tolerability profile was similar to placebo and consistent with previous clinical studies [18] . [22]
Pharmacodynamics
Summary
Clinical
preliminary results from a clinical study in nine patients with early to moderate stage of Huntington's disease (HD) demonstrated that cortical D2 receptor binding potentials were generally well preserved in such patients, indicating that the pathology of HD does not affect extrastriatal D2 receptor baring neurons to the same degree as striatal neurons. Moreover, data showed that the molecular substrate for potential efficacy of dopaminergic agents such as pridopidine is intact in patients with HD [85] .
Preclinical
in vitro binding studies showed that pridopidine binds to the dopamine D2 receptor, with a slight preference towards the high affinity (activated) receptor state. In vivo, pridopidine was demonstrated to strengthen glutamate function in the frontal cortex. This may enhance in vivo behavioural effects in states of excessively high dopamine activity or excessively low glutamate activity, while not affecting behaviour under normal conditions [86] .
In vitro
pridopidine acted as a pure antagonist with no intrinsic activity; had antagonist activity surmountable by dopamine; and demonstrated fast recovery of receptor-mediated responsiveness. In vivo, pridopidine dose-dependently reduced locomotor activity in hyperactive rats. In addition, administration of pridopidine increased levels of dopamine and norepinephrine [84] .
In dopamine D2 receptor knockout mice, the actions of the dopamine stabiliser (pridopidine) relevant to the dopaminergic system and antipsychotic efficacy were not mediated solely through dopamine D2 receptors. Pridopidine (3−60 mg/kg), (-)-OSU 6162 (60 mg/kg) and haloperidol (0.05−0.6 mg/kg) significantly inhibited spontaneous locomotor and amphetamine-induced hyperactivity in wild-type mice. The effects of (-)-OSU 6162 and haloperidol were absent in mice lacking dopamine D2 receptors. However, pridopidine significantly inhibited spontaneous LMA- and amphetamine-induced hyperactivity in the D2 knockout mice. Neurochemical analysis of brain monoamine levels revealed that in the striatum of wild-type mice, all three compounds increased tissue levels of DOPAC and HVA. These effects were not present in the dopamine D2 receptor knockout mice. Furthermore, pridopidine, but not (-)-OSU 6162 or haloperidol, increased DOPAC, HVA and MHPG and decreased norepinephrine (NE) in the medial pre-frontal cortex of wild-type and D2 receptor knockout animals [83] .
Therapeutic Trials
Amyotrophic lateral sclerosis
Result from a phase II/III HEALEY ALS platform trial showed that the quantitative speech measures with significant improvement in speaking rate (p=0.028) and articulation rate (p=0.013) was observed from the pre-specified analyses [18] [23] [22] .
Huntington's disease
Phase III
meta-analysis of pooled datasets from the HART and MermaiHD studies supported the conclusions drawn from each individual trial. On the Total Motor Score (TMS), the analysis showed a significant improvement from treatment with pridopidine of -2.1 points and -3.3 points at week 12 and week 26, respectively. On the modified Motor Score (mMS), there was a -0.6 point change at week 12 and at week 26 a significant improvement of -1.2 points [80] .
Treatment with twice-daily pridopidine 45mg for 26 weeks improved motor function in the phase III MermaiHD trial, with a significance value of p < 0.042, which did not meet the prespecified significance level of p < 0.025 for the primary endpoint (NCT00665223). However, a modified analysis of the primary endpoint data, with inclusion of CAG repeats present in the Huntington gene, showed that the significance value for improvements in motor function with pridopidine versus placebo was p < 0.02. This randomised, double-blind, placebo controlled trial included 437 patients with Huntington's disease. In addition to the improvements in the mMS, twice-daily pridopidine treatment also significantly improved the TMS, eye movements and dystonia. Once-daily treatment did not significantly improve these symptoms [82] [50] . Pridopidine also appeared to have disease-modifying effects, according to an additional analysis of top-line results from MermaiHD. The data revealed that disease progression in placebo-treated patients was related to the number of CAG repeats present in the Huntington gene, whereas, patients treated with pridopidine showed no such trend [54] [78] [81] .
Results from the phase III PROOF-HD trial indicated that the study did not meet its primary endpoint, change from baseline compared to placebo at 65 weeks, as measured by the Unified Huntington Disease Rating Scale-Total Functional Capacity score (TFC), or the key secondary endpoint, measured by the Composite Unified Huntington’s Disease Rating Scale (cUHDRS). Effects on both of these measures were reduced by the use of concomitant medications. Pre-specified analyses that excluded participants taking neuroleptics and chorea medications showed clinically meaningful and nominally significant benefits for participants on pridopidine across multiple measures, including disease progression (cUHDRS) and cognition (Stroop Word Reading Test, SWR), at various timepoints. There were also positive trends in motor (TMS) and function (TFC). For many of these measures, this represented improvement from baseline values. Additionally, important secondary endpoints measuring Q-Motor, a quantitative, objective, rater-bias independent, computerized assessment of motor function, showed robust and nominally significant beneficial effects for participants on pridopidine and improvement from baseline. The effect was further strengthened when excluding participants taking neuroleptics and chorea medications [37] [32] .
Phase II: Compared with placebo, twice-daily pridopidine 45mg was not associated with a significant improvement from baseline in modified Motor Score at 12 weeks (primary endpoint; improvement of 1.2 points) in 227 patients with Huntington's disease from the US and Canada. Significant improvements, however, were observed in TMS. For both mMS and TMS, a significant improvement in from baseline was observed with increasing doses of pridopidine. The effect sizes for both mMS and TMS observed in this randomised, phase II, double-blind trial (HART) were consistent with those observed in the MermaiHD trial [58] .
Pridopidine (45mg, 67.5mg, 90mg and 112.5mg) did not improve motor function at Week 26 as compared with placebo, in the phase II Pride-HD study. Total motor score (TMS) (primary endpoint) at Week 26 was not met for any dosage. TFC declined less in patients treated with certain doses of pridopidine than placebo. TFC declined less at Week 52 with 45mg bid (n = 75) than placebo (n = 81) (LS mean difference: 0.87 [95% CI: 0.29 - 1.45], p = 0.003). Compared with placebo (n = 62), delay of TFC decline was particularly seen in the early-stage subpopulation treated with pridopidine 45mg bid (n = 59; Week 26: 0.56 [0.04 - 1.08], p = 0.036; Week 52: 1.16 [0.54 - 1.78], p = 0.0003) and 90mg bid (n = 56; Week 26: 0.61 [0.10 - 1.13], p = 0.020; Week 52: 0.72 [0.10 - 1.33], p = 0.0239) [64] . Topline results from the study demonstrated improvements in early stage Huntington's disease (HD) patients in patients in elements that make up TFC, such as the ability to undertake domestic chores, activities of daily living and impact on ability to manage finances. Patients' mobility and ambulation may have contributed to improved TFC scores, with multiple ambulation-related endpoints like gait, walking, ability to get up from sitting and walk and stair climbing demonstrating trends favouring pridopidine. The randomised, double-blind trial assessed the efficacy, safety and tolerability of pridopidine in 408 HD patients demonstrating signs of motor dysfunction [65] [67] .
Pridopidine improved symptoms in patients with Huntington's disease. In this phase II trial, 58 patients were randomised to receive pridopidine or placebo, for 4 weeks. Treatment with pridopidine improved motor function, in particular chorea, as well as gait and dysarthria; moreover, pridopidine reduced akinesia and produced a strong trend towards reductions symptoms of anxiety and depression. Patients who received pridopidine also experienced improvements in performance of the Trail Making test, a test of cognitive function [87] .
Interim data from the open-label, long term phase II OPEN-HART trial in patients with Huntington's disease (HD) demonstrated a slower total functional capacity (TFC) decline for pridopidine-treated HD patients compared with matched placebo controls from other studies. The mean change from baseline in total functional capacity (TFC) at 12, 24, and 36 months for Open-HART trial was –0.7 (1.8); –1.3 (2.1), –1.8 (2.3) and was comparable to matched placebo controls from 2CARE and CARE-HD trials. Open-HART had a significantly slower decline than 2CARE at 24 months ( P = 0.02) and CARE- HD at 30 months ( P = 0.04). The trial enrolled 235 patients who had completed the HART trial, including the follow-up period, or the PRIDE-HD trial [61] [63] .
Parkinson's disease
Adjunctive pridopidine increased on time in patients with advanced Parkinson's disease. In this phase II study, 7 patients received pridopidine titrated in steps to 20, 50, 70 and 100 mg/day or the maximum tolerated dose over the first week. Treatment was administered once daily for 14 days. Patients reported an increase in on time, without dyskinesias, and a corresponding decrease in on time with dyskinesias. However, total daily on and off time did not change significantly from baseline [74] .
Future Events
| Expected Date | Event Type | Description | Updated |
|---|---|---|---|
| 31 Dec 2024 | Trial Update | Prilenia Therapeutics plans the phase-III pivotal trial for Amyotrophic lateral sclerosis in the H2 2024 (PO). [18] | 25 Jan 2024 |
| 30 Jun 2024 | Regulatory Status | Prilenia Therapeutics plans to submit Marketing Authorization Application for Huntington’s disease in the EU in mid-2024 (9412224) [26] | 18 Apr 2024 |
| 31 Jul 2021 | Regulatory Status | Prilenia Therapeutics expects Orphan Drug Designation for pridopidine in Amyotrophic lateral sclerosis in Europe, by end-of July 2021 [16] | 01 Jul 2021 |
| 31 Dec 2020 | Trial Update | Prilenia plans a phase III trial for Huntington's disease in the second half of 2020 (PO) [77] | 03 Nov 2020 |
| 30 Nov 2020 | Trial Update | Prilenia Therapeutics plans a phase II/III trial for Amyotrophic lateral sclerosis (In adults, In the elderly) in November 2020 (NCT04615923) | 08 Jan 2021 |
| 30 Apr 2019 | Trial Update | Prilenia Therapeutics plans a phase II trial for Parkinson's disease (in adults, In the elderly) in April 2019 (NCT03922711) (700306779) | 20 Sep 2019 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 12 Apr 2024 | Regulatory Status | Prilenia Therapeutics plans to submit Marketing Authorization Application for Huntington’s disease in the EU in mid-2024 [28] [26] Updated 18 Apr 2024 |
| 12 Mar 2024 | Regulatory Status | Prilenia Therapeutics plans to submit global regulatory submissions for additional countries for Huntington’s disease [28] Updated 20 Mar 2024 |
| 19 Jan 2024 | Scientific Update | Efficacy and adverse events data from phase II/III HEALEY ALS platform trial in Amyotrophic lateral sclerosis released by Prilenia Therapeutics [18] Updated 25 Jan 2024 |
| 19 Jan 2024 | Trial Update | Prilenia Therapeutics plans the phase-III pivotal trial for Amyotrophic lateral sclerosis in the H2 2024 (PO). [18] Updated 25 Jan 2024 |
| 28 Oct 2023 | Phase Change - No development reported | No recent reports of development identified for preclinical development in Alzheimer's-disease in Israel (PO) Updated 28 Oct 2023 |
| 28 Oct 2023 | Phase Change - No development reported | No recent reports of development identified for preclinical development in Eye-disorders in Israel (PO) Updated 28 Oct 2023 |
| 28 Oct 2023 | Phase Change - No development reported | No recent reports of development identified for preclinical development in Fragile-X-syndrome in Israel (PO) Updated 28 Oct 2023 |
| 28 Oct 2023 | Phase Change - No development reported | No recent reports of development identified for preclinical development in Rett syndrome in Israel (PO) Updated 28 Oct 2023 |
| 06 Oct 2023 | Trial Update | Prilenia in collaboration with Massachusetts General Hospital, National Institute of Neurological Disorders and Stroke (NINDS) and National Institutes of Health (NIH) initiated expanded access for pridopidine for amyotrophic lateral sclerosis (NCT06069934) Updated 11 Oct 2023 |
| 26 Apr 2023 | Scientific Update | Efficacy and averse events data from a phase III trial for Huntington Disease presented at the 75th Annual Meeting of the American Academy of Neurology (AAN-2023) [37] Updated 27 Apr 2023 |
| 28 Mar 2023 | Trial Update | Prilenia Therapeutics completes a phase III trial for Huntington Disease (In Adults, In Elderly)in the US, Austria, Canada, Czech Republic, France, Germany, Italy, Netherlands, Poland, Spain and UK [29] (NCT04556656) (EudraCT2020-002822-10) Updated 02 Apr 2023 |
| 23 Feb 2023 | Scientific Update | Efficacy and adverse events data from a phase II/III trial in Amyotrophic lateral sclerosis released by Prilenia Therapeutics [23] Updated 02 Mar 2023 |
| 28 Oct 2022 | Phase Change - No development reported | No recent reports of development identified for phase-I development in Amyotrophic-lateral-sclerosis in Israel (PO) Updated 28 Oct 2022 |
| 14 Jul 2022 | Trial Update | Prilenia Therapeutics and Massachusetts General Hospital completes phase II/III HEALEY ALS platform trial in Amyotrophic lateral sclerosis in USA (PO) (NCT04615923) Updated 01 Sep 2023 |
| 05 Jan 2022 | Regulatory Status | Pridopidine receives Orphan Drug status for Amyotrophic lateral sclerosis in Europe, prior to January 2022 [15] Updated 10 Jan 2022 |
| 05 Jan 2022 | Trial Update | Prilenia Therapeutics and Massachusetts General Hospital complete enrolment in the phase II/III HEALEY ALS platform trial in Amyotrophic lateral sclerosis in USA (PO) [15] (NCT04615923) Updated 10 Jan 2022 |
| 17 Nov 2021 | Regulatory Status | Pridopidine - Prilenia Therapeutics receives Fast Track designation for Huntington's disease [PO,Capsule] (In the elderly, In adults) in USA [27] Updated 19 Nov 2021 |
| 21 Oct 2021 | Phase Change - III | Phase-III clinical trials in Huntington's disease (In adults, In the elderly) in Czech Republic (PO) [33] (NCT04556656) (EudraCT2020-002822-10) Updated 19 Nov 2021 |
| 21 Oct 2021 | Phase Change - III | Phase-III clinical trials in Huntington's disease (In adults, In the elderly) in France (PO) [33] (NCT04556656) (EudraCT2020-002822-10) Updated 19 Nov 2021 |
| 20 Oct 2021 | Trial Update | Prilenia Therapeutics completes enrolment in its phase III trial for Huntington Disease in the US, Austria, Canada, Czech Republic, France, Germany, Italy, Netherlands, Poland, Spain and UK [33] (NCT04556656) (EudraCT2020-002822-10) Updated 10 Nov 2021 |
| 24 Sep 2021 | Biomarker Update | Biomarkers information updated Updated 02 Oct 2021 |
| 12 Jul 2021 | Regulatory Status | Pridopidine - Prilenia Therapeutics receives Orphan Drug status for Amyotrophic lateral sclerosis in USA [14] Updated 14 Jul 2021 |
| 29 Jun 2021 | Regulatory Status | Prilenia Therapeutics expects Orphan Drug Designation for pridopidine in Amyotrophic lateral sclerosis in Europe, by end-of July 2021 [16] Updated 01 Jul 2021 |
| 29 Jun 2021 | Regulatory Status | Prilenia Therapeutics receives positive EMA opinion on Orphan Drug Designation for pridopidine in Amyotrophic lateral sclerosis [16] Updated 01 Jul 2021 |
| 04 May 2021 | Phase Change - III | Phase-III clinical trials in Huntington's disease (In adults, In the elderly) in Austria (PO) [35] (NCT04556656) (EudraCT2020-002822-10) Updated 21 May 2021 |
| 04 May 2021 | Phase Change - III | Phase-III clinical trials in Huntington's disease (In adults, In the elderly) in Canada (PO) [35] (NCT04556656) (EudraCT2020-002822-10) Updated 21 May 2021 |
| 04 May 2021 | Phase Change - III | Phase-III clinical trials in Huntington's disease (In adults, In the elderly) in Italy (PO) [35] (NCT04556656) (EudraCT2020-002822-10) Updated 21 May 2021 |
| 04 May 2021 | Phase Change - III | Phase-III clinical trials in Huntington's disease (In adults, In the elderly) in Netherlands (PO) [35] (NCT04556656) (EudraCT2020-002822-10) Updated 21 May 2021 |
| 04 May 2021 | Phase Change - III | Phase-III clinical trials in Huntington's disease (In adults, In the elderly) in Poland (PO) [35] (NCT04556656) (EudraCT2020-002822-10) Updated 21 May 2021 |
| 04 May 2021 | Phase Change - III | Phase-III clinical trials in Huntington's disease (In adults, In the elderly) in Spain (PO) [35] (NCT04556656) (EudraCT2020-002822-10) Updated 21 May 2021 |
| 04 May 2021 | Phase Change - III | Phase-III clinical trials in Huntington's disease (In adults, In the elderly) in United Kingdom (PO) [35] (NCT04556656) (EudraCT2020-002822-10) Updated 21 May 2021 |
| 29 Jan 2021 | Regulatory Status | Regulatory body approves IND application for Pridopidine in Italy, Austria, Czech Republic, France, Germany, Italy, the Netherlands, Spain and Poland [30] Updated 30 Jan 2021 |
| 11 Dec 2020 | Phase Change - III | Phase-III clinical trials in Huntington's disease (In adults, In the elderly) in Germany (PO) (EudraCT2020-002822-10) [30] Updated 30 Jan 2021 |
| 05 Nov 2020 | Trial Update | Prilenia Therapeutics terminates a phase-II trial in Parkinson's disease (In adults, In the elderly) in USA due to COVID-19 pandemic (PO) (NCT03922711) Updated 19 Nov 2020 |
| 04 Nov 2020 | Trial Update | Prilenia Therapeutics plans a phase II/III trial for Amyotrophic lateral sclerosis (In adults, In the elderly) in November 2020 (NCT04615923) Updated 08 Jan 2021 |
| 27 Oct 2020 | Phase Change - III | Phase-III clinical trials in Huntington's disease (In adults, In the elderly) in USA (PO) [31] (NCT04556656) Updated 03 Nov 2020 |
| 10 Sep 2020 | Regulatory Status | Prilenia Therapeutics plans to submit marketing authorisation applications for pridopidine [13] Updated 14 Sep 2020 |
| 10 Sep 2020 | Regulatory Status | Prilenia Therapeutics plans to commercialise pridopidine [13] Updated 14 Sep 2020 |
| 14 Jul 2020 | Phase Change - II/III | Phase-II/III clinical trials in Amyotrophic lateral sclerosis in USA (PO) (NCT04615923) (NCT04297683) Updated 08 Jan 2021 |
| 03 Jun 2020 | Trial Update | Prilenia plans a phase III trial for Huntington's disease in the second half of 2020 (PO) [77] Updated 03 Nov 2020 |
| 20 Sep 2019 | Phase Change - I | Phase-I clinical trials in Amyotrophic lateral sclerosis in Israel (PO) (Prilenia Therapeutics pipeline, September 2019) Updated 20 Sep 2019 |
| 20 Sep 2019 | Phase Change - Preclinical | Preclinical trials in Alzheimer's disease in Israel (PO) prior to September 2019 (Prilenia Therapeutics pipeline, September 2019) Updated 20 Sep 2019 |
| 20 Sep 2019 | Phase Change - Preclinical | Preclinical trials in Eye disorders in Israel (PO) prior to September 2019 (Prilenia Therapeutics pipeline, September 2019) Updated 20 Sep 2019 |
| 20 Sep 2019 | Phase Change - Preclinical | Preclinical trials in Fragile X syndrome in Israel (PO) prior to September 2019 (Prilenia Therapeutics pipeline, September 2019) Updated 20 Sep 2019 |
| 20 Sep 2019 | Phase Change - Preclinical | Preclinical trials in Rett syndrome in Israel (PO) prior to September 2019 (Prilenia Therapeutics pipeline, September 2019) Updated 20 Sep 2019 |
| 19 Sep 2019 | Phase Change - Preclinical | Preclinical trials in Amyotrophic lateral sclerosis in Israel (PO) prior to September 2019 [24] Updated 20 Sep 2019 |
| 19 Sep 2019 | Trial Update | Prilenia Therapeutics plans a clinical trial (the HEALEY ALS Platform trial) for Amyotrophic lateral sclerosis in USA [24] Updated 20 Sep 2019 |
| 30 Apr 2019 | Trial Update | Prilenia Therapeutics plans a phase II trial for Parkinson's disease (in adults, In the elderly) in April 2019 (NCT03922711) Updated 20 Sep 2019 |
| 30 Apr 2019 | Phase Change - Preclinical | Preclinical trials in Parkinson's disease in Israel (PO) Updated 30 Apr 2019 |
| 26 Mar 2019 | Phase Change - II | Phase-II clinical trials in Parkinson's disease (In adults, In the elderly) in USA (PO) (NCT03922711) Updated 22 May 2019 |
| 30 Dec 2018 | Patent Information | Prilenia Therapeutics has patent protection for pridopidine in USA [1] Updated 30 Apr 2019 |
| 16 May 2018 | Phase Change - Discontinued(II) | Discontinued - Phase-II for Huntington's disease in Australia, Poland, Poland, Russia, Denmark, USA, Canada, Austria, France, Germany, Italy, Italy, United Kingdom and Netherlands due to failure to meet primary endpoint (PO) [8] Updated 23 May 2018 |
| 16 May 2018 | Phase Change - Discontinued(II/III) | Discontinued - Phase-II/III for Huntington's disease in Canada and USA due to failure to meet primary endpoint (PO) [8] Updated 23 May 2018 |
| 16 May 2018 | Phase Change - Discontinued(III) | Discontinued - Phase-III for Huntington's disease in Austria, Belgium, United Kingdom, Germany, France, Italy, Spain and Portugal due to failure to meet primary endpoint (PO) [8] Updated 23 May 2018 |
| 31 Jan 2018 | Trial Update | Teva Branded Pharmaceutical Products, R&D completes a phase I trial for Huntington’s disease in Germany (PO, Capsule) (NCT03019289) Updated 22 May 2018 |
| 12 Jan 2018 | Trial Update | Teva Pharmaceutical terminates a phase II trial in Huntington's disease in USA, Australia, Austria, Canada, Russia, Netherlands, France, Germany, Italy, Poland and United Kingdom, as the study served its purpose in providing considerable safety data (PO, Capsule) (NCT02494778) Updated 05 Sep 2018 |
| 22 Apr 2017 | Scientific Update | Interim efficacy data from the phase II Open-HART trial in Huntington's disease presented at the 69th Annual Meeting of the American Academy of Neurology (AAN-2017) [61] Updated 12 Jul 2017 |
| 22 Apr 2017 | Scientific Update | Efficacy data from the phase II Pride-HD in Huntington's disease presented at the 69th Annual Meeting of the American Academy of Neurology (AAN-2017) [64] Updated 14 Jun 2017 |
| 17 Mar 2017 | Trial Update | Teva Branded Pharmaceutical Products, R&D initiates a phase I trial for Huntington’s disease in Germany (PO, Capsule) (NCT03019289) Updated 03 Apr 2017 |
| 11 Jan 2017 | Trial Update | Teva Branded Pharmaceutical Products, R&D plans a phase I trial for Huntington’s disease in Germany (PO, Capsule) (NCT03019289) Updated 16 Jan 2017 |
| 19 Sep 2016 | Scientific Update | Interim adverse events and efficacy data from phase II Pride-HD trial in Huntington's disease released by Teva [65] Updated 21 Sep 2016 |
| 01 Aug 2016 | Trial Update | Teva Pharmaceutical Industries completes a phase-II trial in Huntington's disease in USA, Australia, Austria, Canada, Denmark, France, Germany, Italy, Netherlands, Poland, Russia, United Kingdom (PO, capsule) (NCT02006472) Updated 30 Sep 2016 |
| 09 Sep 2015 | Active Status Review | Prilopidine is still in phase-II/III development for Huntington's disease in USA and Canada Updated 09 Sep 2015 |
| 01 Sep 2015 | Trial Update | Teva initiates a phase II trial for Huntington's disease in USA, Australia, Austria, Canada, Russia, Netherlands, France, Germany, Italy, Poland and United Kingdom (PO, Capsule) (NCT02494778) Updated 16 Jan 2017 |
| 13 Jul 2015 | Trial Update | Teva plans a phase II trial for Huntington's disease in USA, Austria, France, Denmark, Germany, Italy, Poland, Netherlands and United Kingdom (NCT02494778) Updated 13 Jul 2015 |
| 01 Feb 2014 | Phase Change - II | Phase-II clinical trials in Huntington's disease in USA, Australia, Austria, Canada, Denmark, France, Germany, Italy, Netherlands, Poland, Russia, United Kingdom (PO, capsule) (NCT02006472) Updated 30 Sep 2016 |
| 05 Dec 2013 | Trial Update | Teva Pharmaceutical Industries plans a phase II trial for Huntington disease in Australia, Austria, Canada, Czech Republic, Denmark, France, Germany, Italy, Netherlands, Poland, Russia, United Kingdom and USA (NCT02006472) Updated 17 Dec 2013 |
| 13 Mar 2013 | Trial Update | Teva Pharmaceutical Industries completes enrolment in the phase III OPEN-HART extension trial for Huntington's disease in USA & Canada (NCT01306929) Updated 10 Apr 2013 |
| 27 Sep 2012 | Licensing Status | NeuroSearch and Teva Pharmaceutical Industries enter into a conditional asset transfer agreement, whereby Teva acquired all rights, assets and obligations pertaining to pridopidine [3] , [5] , [4] Updated 01 Oct 2012 |
| 28 May 2012 | Scientific Update | Final adverse events data from a phase I trial in healthy volunteers released by NeuroSearch [42] Updated 30 May 2012 |
| 01 May 2012 | Trial Update | NeuroSearch completes a phase I trial in healthy volunteers [42] Updated 30 May 2012 |
| 28 Sep 2011 | Licensing Status | Pridopidine is available for licensing as of 27 Sep 2011. http://neurosearch.com Updated 28 Sep 2011 |
| 04 Jul 2011 | Active Status Review | Clinical development is ongoing in the European Union, USA and Canada Updated 04 Jul 2011 |
| 30 Jun 2011 | Trial Update | NeuroSearch completes the phase II/III HART trial in Huntington's disease in USA & Canada (NCT00724048) Updated 29 Jul 2011 |
| 05 Apr 2011 | Trial Update | NeuroSearch initiates enrolment in the open-label extension study (OPEN-HART) of pridopidine in patients with Huntington's disease in the US and Canada (NCT01306929) Updated 05 Apr 2011 |
| 25 Mar 2011 | Regulatory Status | NeuroSearch completes an End of Phase II meeting with the US FDA and provides an update on the development plan for pridopidine for the treatment of Huntington's disease [41] Updated 25 Mar 2011 |
| 30 Dec 2010 | Scientific Update | Meta-analysis efficacy data from pooled datasets from the HART and MermaiHD studies released by NeuroSearch [80] Updated 01 Jan 2011 |
| 15 Oct 2010 | Scientific Update | Efficacy and adverse events data from the HART trial in Huntington's disease released by NeuroSearch A/S [58] Updated 15 Oct 2010 |
| 15 Sep 2010 | Scientific Update | Interim adverse events data from the phase III MermaiHD extension trial in Huntington's disease released by NeuroSearch [54] Updated 17 Sep 2010 |
| 25 Aug 2010 | Regulatory Status | Pridopidine is available under European compassionate use programme for patients who participated in a phase III study in Huntington's disease [59] Updated 26 Aug 2010 |
| 12 Aug 2010 | Active Status Review | Pridopidine is still in a phase III trial for Huntington's disease in the EU Updated 12 Aug 2010 |
| 18 May 2010 | Trial Update | NeuroSearch completes enrolment in the phase II/III HART trial in Huntington's disease in USA and Canada (NCT00724048) Updated 17 Mar 2011 |
| 30 Apr 2010 | Scientific Update | The revised analysis of efficacy data from the phase III trial in Huntington's disease released by NeuroSearch [81] Updated 30 Apr 2010 |
| 08 Mar 2010 | Scientific Update | Additional efficacy data from a phase III trial in Huntington's disease released by NeuroSearch [78] Updated 11 Mar 2010 |
| 12 Feb 2010 | Scientific Update | Additional efficacy data from a phase III trial in Huntington's disease released by NeuroSearch [82] Updated 16 Feb 2010 |
| 03 Feb 2010 | Scientific Update | Interim efficacy and adverse events data from a phase III trial in Huntington's disease released by NeuroSearch [50] Updated 09 Feb 2010 |
| 21 Oct 2009 | Scientific Update | Pharmacodynamics data from a preclinical trial in Psychotic disorders presented at the 39th Annual Meeting of the Society for Neuroscience (SfN-2009) [83] Updated 02 Nov 2009 |
| 16 Sep 2009 | Scientific Update | Preclinical pharmacodynamics data presented at the World Congress on Huntington's Disease (WCHD-2009) [84] Updated 18 Sep 2009 |
| 11 Jun 2009 | Scientific Update | Pharmacodynamics data from a clinical trial in Huntington's disease presented at the 13th International Congress of Parkinson's Disease and Movement Disorders (PDMD-2009) [85] Updated 24 Jun 2009 |
| 29 Apr 2009 | Scientific Update | Pharmacodynamics and pharmacokinetics data from a preclinical trial in Huntington's disease released by NeuroSearch [86] Updated 01 May 2009 |
| 31 Mar 2009 | Trial Update | NeuroSearch completes enrolment in the phase III MermaiHD trial for Huntington's disease in the EU Updated 02 Apr 2009 |
| 04 Mar 2009 | Phase Change - III | Phase-III clinical trials in Huntington's disease in Portugal (PO) Updated 01 May 2013 |
| 02 Mar 2009 | Licensing Status | NeuroSearch regains global rights to ACR 16 for all indications after termination of the licensing agreement with Astellas [9] Updated 05 Mar 2009 |
| 02 Mar 2009 | Phase Change - Discontinued(I) | Discontinued - Phase-I for Schizophrenia in Sweden (PO) Updated 05 Mar 2009 |
| 27 Oct 2008 | Phase Change - II/III | Phase-II/III clinical trials in Huntington's disease in Canada (PO) Updated 17 Mar 2011 |
| 27 Oct 2008 | Phase Change - II/III | Phase-II/III clinical trials in Huntington's disease in USA (PO) Updated 17 Mar 2011 |
| 27 Oct 2008 | Trial Update | NeuroSearch initiates dosing in the phase II/III study (HART) for Huntington's disease Updated 29 Oct 2008 |
| 06 Oct 2008 | Phase Change - III | Phase-III clinical trials in Huntington's disease in France, Italy and Spain (PO) Updated 01 May 2013 |
| 07 Jul 2008 | Phase Change - III | Phase-III clinical trials in Huntington's disease in Germany (PO) Updated 01 May 2013 |
| 09 Jun 2008 | Phase Change - III | Phase-III clinical trials in Huntington's disease in Belgium (PO) Updated 01 May 2013 |
| 15 May 2008 | Phase Change - III | Phase-III clinical trials in Huntington's disease in Austria (PO) Updated 01 May 2013 |
| 15 May 2008 | Phase Change - III | Phase-III clinical trials in Huntington's disease in United Kingdom (PO) Updated 01 May 2013 |
| 01 Oct 2007 | Regulatory Status | NeuroSearch files a CTA with the EMEA for the initiation of a clinical phase III programme for Huntington's disease in the EU Updated 04 Oct 2007 |
| 21 Jun 2007 | Active Status Review | Clinical development is ongoing with ACR 16 for Huntington's disease and Schizophrenia Updated 21 Jun 2007 |
| 27 Nov 2006 | Phase Change - Discontinued(I) | Discontinued - Phase-I for Parkinson's disease in Sweden (PO) Updated 28 Nov 2006 |
| 03 Nov 2006 | Company Involvement | Carlsson Research is now called NeuroSearch AB Updated 03 Nov 2006 |
| 23 Oct 2006 | Company Involvement | Carlsson Research has been acquired by NeuroSearch Updated 30 Oct 2006 |
| 08 May 2006 | Scientific Update | Results from a phase II trial (ACR16C007) in Huntington's disease added to the adverse events and Parkinson's Disease and Movement Disorders therapeutic trials sections [87] Updated 24 Nov 2006 |
| 13 Jan 2006 | Phase Change - II | Phase-II clinical trials in Huntington's disease in USA (PO) Updated 22 Feb 2006 |
| 13 Jan 2006 | Regulatory Status | ACR 16 receives Orphan Drug Status for Huntington's disease in USA Updated 22 Feb 2006 |
| 21 Jun 2005 | Regulatory Status | ACR 16 receives Orphan Drug Status for Huntington's disease in European Union Updated 28 Nov 2006 |
| 23 Apr 2005 | Phase Change - II | Phase-II clinical trials in Huntington's disease in European Union (PO) Updated 22 Feb 2006 |
| 11 Apr 2005 | Company Involvement | Yamanouchi has merged with Fujisawa to form Astellas Pharma Updated 11 Apr 2005 |
| 09 Feb 2005 | Licensing Status | Exclusive rights to develop, manufacture and market ACR 16 worldwide has been licensed to Fujisawa Pharmaceuticals Updated 18 Feb 2005 |
| 07 Feb 2005 | Active Status Review | Phase I development is ongoing for Schizophrenia in Sweden Updated 22 Feb 2006 |
| 07 Feb 2005 | Phase Change - I | Phase-I clinical trials in Huntington's disease in Sweden (PO) Updated 22 Feb 2006 |
| 07 Feb 2005 | Phase Change - I | Phase-I clinical trials in Parkinson's disease in Sweden (PO) Updated 22 Feb 2006 |
| 14 Jun 2004 | Scientific Update | Data presented at the 8th International Congress of Parkinson's Disease and Movement Disorders (PDMD-2004) added to the adverse events and Parkinson's Disease and Movement Disorders therapeutic trials sections [74] Updated 24 Nov 2006 |
| 31 Mar 2003 | Licensing Status | Carlsson Research and Merck & Co have have entered into a research agreement that allows Merck to develop and market compounds from the dopamine stabiliser programme Updated 31 Mar 2003 |
| 19 Apr 2002 | Phase Change - I | Phase-I clinical trials in CNS disorders in Sweden (PO) Updated 10 Feb 2005 |
| 19 Apr 2002 | Phase Change - I | Phase-I clinical trials in Schizophrenia in Sweden (PO) Updated 10 Jul 2002 |
References
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Hydrobromide salt of pridopidine. Internet-Doc 2019;.
Available from: URL: https://patents.google.com/patent/US9012476B2/en -
NeuroSearch A/S receives notice of payment from Teva Pharmaceutical International GmbH regarding Pridopidine and changes financial outlook for 2018.
Media Release -
Teva Expands Central Nervous System (CNS) Development Pipeline with Acquisition of Huntexil(Rm) Development Program Rights from NeuroSearch A/S
Media Release -
NeuroSearch A/S closes the sale of Huntexil(RM) to Teva Pharmaceutical Industries Ltd. and adjusts the expectations to the full-year result.
Media Release -
NeuroSearch A/S and Teva Pharmaceutical Industries Ltd. sign Huntexil(Rm) asset transfer agreement conditional upon NeuroSearch shareholder approval
Media Release -
NeuroSearch receives notification on date for release of escrow relating to Huntexil.
Media Release -
NeuroSearch A/S - H1 report 2017.
Media Release -
NeuroSearch and Teva Pharmaceutical International enter into agreement on outstanding obligations.
Media Release -
NeuroSearch regains global rights to ACR16.
Media Release -
Fujisawa Obtains the Worldwide Rights on Antipsychotic Agent from Carlsson Research.
Media Release -
NeuroSearch to Acquire Carlsson Research.
Media Release -
NeuroSearch closes acquisition of A. Carlsson Research AB and adjusts its outlook for the full year and warrant programmes.
Media Release -
Henk Schuring Joins Prilenia as Chief Regulatory and Commercialization Officer.
Media Release -
Prilenia: FDA Grants Orphan Drug Designation for pridopidine for the Treatment of Amyotrophic Lateral Sclerosis (ALS).
Media Release -
Prilenia Announces Completion of Patient Enrollment Ahead of Schedule in the Pridopidine Arm of the HEALEY ALS Platform Trial.
Media Release -
Prilenia receives positive EMA opinion on Orphan Drug Designation for pridopidine in ALS.
Media Release -
A Second Intermediate-Size Expanded Access Protocol (EAP) for Pridopidine in People With Amyotrophic Lateral Sclerosis (Pridopidine EAP 2)
ctiprofile -
Prilenia Announces Clinical Data in Support of its Plans to Initiate Global Phase 3 Study in ALS.
Media Release -
Prilenia Announces First Patient Enrolled for Pridopidine Phase 2/3 Platform Trial for ALS.
Media Release -
HEALEY ALS Platform Trial - Regimen D Pridopidine
ctiprofile -
Aural Analytics Speech Technology Signaled Slowing of Decline in ALS Patients Speech and Bulbar Function in Platform Trial Evaluating Pridopidine.
Media Release -
HEALEY ALS Platform Trial
ctiprofile -
Prilenia Announces Topline Results for Pridopidine in Phase 2 ALS Study.
Media Release -
Prilenias Pridopidine Chosen to Participate in the First ALS Platform Trial.
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A Double-Blind, Randomized, Three-Arm, Parallel-Group Study to Assess the Efficacy and Safety of Two Doses of Pridopidine Versus Placebo for the Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson's Disease (gLIDe)
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Prilenia to Present Latest Research from its Pridopidine Programs for Huntington Disease and ALS at AAN 2024.
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Prilenia Receives Fast Track Designation for Pridopidine for the Treatment of Huntingtons Disease.
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Prilenia Plans to Submit Marketing Authorization Application (MAA) in the EU for Pridopidine in Huntington's Disease.
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Prilenia Achieves Last Patient Last Visit in Phase 3 PROOF-HD Clinical Study for Huntington's Disease.
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Prilenia Enrolls First Subject in Europe in its PROOF-HD Phase 3 Clinical Trial for Huntingtons Disease.
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Prilenia Enrolls First Patients Into its PROOF-HD Phase 3 Clinical Trial for Huntingtons Disease in the United States.
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A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Arm, Multicenter Study Evaluating the Efficacy and Safety of Pridopidine in Patients With Early Stage of Huntington Disease
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Prilenia and Huntington Study Group Announce Completion of Patient Enrollment Ahead of Schedule in Global Phase 3 PROOF-HD Huntingtons Disease Clinical Trial.
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Prilenias Phase 3 Huntingtons Disease Clinical Trial Achieves 50% Enrollment.
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Prilenia Achieves 25% Enrollment in its Phase 3 HD Trial and Appoints Dr. Goldberg as CSO.
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Goldberg YP, Reilmann R, Feigin A, Rosser A, Kostyk S, Cohen Y, et al. Topline results of the PROOF-HD pivotal phase 3 trial: PRidopidines Outcome On Function in Huntington Disease. AAN-2023 2023; abstr. N/A.
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Prilenia Shares Preliminary Topline Results from Phase 3 PROOF-HD Clinical Trial in Huntington's Disease and Data from Phase 2 HEALEY ALS Platform Trial of Pridopidine at the 75th American Academy of Neurology (AAN) Annual Meeting.
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NeuroSearch announces pridopidine as the generic name for ACR16, the company's novel drug in pivotal stage development for Huntington's disease.
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NeuroSearch A/S provides update on the process to secure financing to complete the Huntexil(Rm) development programme.
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NeuroSearch A/S - Interim report for Q1 2011.
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NeuroSearch provides an update on the development plan for Huntexil(Rm) in the treatment of Huntington's disease following the End of Phase II meeting with the FDA.
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NeuroSearch A/S reports conclusions from the Multiple Ascending Dose study (MAD) with Huntexil(Rm).
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NeuroSearch provides update on the Huntexil(Rm) development programme and plans a comprehensive restructuring of the company's operations.
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NeuroSearch A/S - Q3 report 2011.
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Phase III registrational trial of pridopidine in patients with Huntington's disease.
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A mandatory QT interval heart study of pridopidine in healthy volunteers.
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A study to assess the abuse potential of pridopidine in recreational drug abusers.
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A bioequivalence study of two formulations of pridopidine.
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NeuroSearch A/S - Quarterly report - NeuroSearch A/S - Interim report for Q1 2010.
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NeuroSearch announces positive top-line results from Phase III Huntexil(R) study in Huntington's disease (the MermaiHD study).
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Correction: NeuroSearch announces the issuance of an EHDN statement supporting the statistical conclusions on the primary endpoint of the MermaiHD study.
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NeuroSearch publishes the MermaiHD study in The Lancet Neurology.
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NeuroSearch A/S - Financial statements and release of Annual Report 2010.
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NeuroSearch announces results from an open-label safety extension to the Phase III MermaiHD study of Huntexil(Rm) in patients with Huntington's disease.
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A Multicentre, Multinational, Randomised, Double-Blind, Parallel-Group Study Comparing ACR16 45 mg Once-Daily or Twice-Daily Versus Placebo for the Symptomatic Treatment of Huntington's Disease
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NeuroSearch A/S - Interim report for the first half-year of 2009.
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NeuroSearch informs of the participation of the Huntington Study Group in the HART study with ACR16 in Huntington's disease.
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The HART study with Huntexil(Rm) shows significant effect on total motor function in patients with Huntington's disease although it did not meet the primary endpoint after 12 weeks of treatment.
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NeuroSearch A/S - Half Year financial report - NeuroSearch A/S - Interim report for H1 2010.
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A Multi-Center, North American, Randomized, Double-Blind, Parallel Group Study Comparing Three Doses of ACR16 Versus Placebo for the Symptomatic Treatment of Huntington Disease (HART)
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McGarry A, Abler V, Auinger P, Grachev I, Gandhi S, Papapetropoulos S. Effect of Pridopidine on Total Functional Capacity (TFC) in Huntington Disease (HD): A Comparison of Open-HART Subjects with Historical Placebo Controls. AAN-2017 2017; abstr. 3119.
Available from: URL: http://submissions.mirasmart.com/AAN2017/itinerary/login.asp -
NeuroSearch announces that the first patient has enrolled in the Open HART safety extension study with Huntexil(Rm).
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A Multi-Center, North American, Open-Label Extension Study of Pridopidine (ACR16) in the Symptomatic Treatment of Huntington's Disease (Open-HART)
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Kieburtz K, Landwehrmeyer GB, Reilmann R, Savola J, Eyal E, Grachev I, et al. Efficacy, Safety, and Tolerability of Pridopidine in Huntington Disease (HD): Results from the Phase II, Double-blind, Placebo-controlled, Dose-Ranging Study, Pride-HD. AAN-2017 2017; abstr. 3075.
Available from: URL: http://submissions.mirasmart.com/AAN2017/itinerary/login.asp -
Teva Announces Results from Exploratory 52-Week Phase 2 PRIDE-HD Study of Pridopidine in Huntington Disease.
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Pride-HD Study Enrolling Patients Globally to Further Evaluate Pridopidine for the Symptomatic Treatment of Huntingtons Disease.
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A Phase 2, Dose-Finding, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study, Evaluating the Safety and Efficacy of Pridopidine 45, 67.5, 90, and 112.5 mg Twice-Daily vs Placebo for Symptomatic Treatment in Patients With Huntington's Disease
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A Multi-Center, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Pridopidine in Patients With Huntington's Disease (Open PRIDE-HD)
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A multiple-ascending dose study of pridopidine in healthy volunteers.
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ACR16 receives Orphan Drug Designation in the US for Huntington's Disease.
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ACR16 receives Orphan Drug Designation in Europe for Huntington's Disease.
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A Phase I, Open-Label, Single-Dose, Adaptive (S)-(-)-[18F]Fluspidine and [18F]Fallypride Positron Emission Tomography Study to Evaluate Sigma-1 and Dopamine-2 Receptor Occupancy by Pridopidine in the Human Brain of Healthy Volunteers and in Patients With Huntington's Disease
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NeuroSearch's license partner Astellas initiates clinical Phase Ib study with ACR16 in patients with schizophrenia.
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Tedroff J, Sonesson C, Waters N, Waters S, Carlsson A. A pilot study of the novel dopamine stabiliser ACR16 in advanced Parkinson's disease. Mov-Disord 2004;19 (Suppl. 9)201-202.
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SV Health Investors Joins Prilenia Series B as the Company Prepares for ALS and HD Data Readouts in the Next 12 Months.
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Prilenia Closes Oversubscribed $43 Million in Series B Financing Round.
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Prilenia Therapeutics Raises $62.5m to Fund Late Stage Trials in HD and ALS.
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NeuroSearch announces new findings from the MermaiHD Phase III study supporting potential disease modifying properties of Huntexil(R).
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Patent approval for treatment of Central Nervous System disorders.
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NeuroSearch announces the results of a meta-analysis of data from a clinical Phase II/III programme with Huntexil(Rm) for Huntington's disease.
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NeuroSearch A/S announces the results of additional assessment and analysis of data from the Phase III MermaiHD study with Huntexil (Rm) in Huntington's disease.
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NeuroSearch presents additional data from the MermaiHD study with Huntexil® at the 5th Annual CHDI Conference on Huntington's disease.
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SVENSSON KA. The actions of the dopamine stabilizer ACR16, but not (-)-OSU6162, in behavioral and neurochemical assays are not dependent on the presence of functional dopamine D2 receptors. 39th-SFN-2009 2009; abstr. 645.16/V6.
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NeuroSearch presents supportive data on the novel therapy HuntexilTM at the World Congress on Huntington's disease.
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Esmaeilzadeh M, Karlsson P, Halldin C, Farde L, Tedroff J. Extrastriatal dopamine D(2) receptor distribution in Huntington's disease using PET. 13th-PDMD-2009 2009;164-165 abstr. Mo-113.
Available from: URL: http://www.movementdisorders.org -
NeuroSearch demonstrates the potential of ACR16 as a novel treatment for Huntington's disease.
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Carlsson Research Reports Positive Effects of ACR16 in Huntington Disease Phase II Study.
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