Crenezumab - AC Immune/Genentech/Universidad-de-Antioquia
Alternative Names: Anti-Abeta antibody; MABT5102A; R 5490245; RG 7412; RO 5490245Latest Information Update: 26 Feb 2024
At a glance
- Originator AC Immune; Universidad de Antioquia
- Developer AC Immune; Genentech; Universidad de Antioquia
- Class Antibodies; Antidementias; Monoclonal antibodies
- Mechanism of Action Amyloid beta-protein inhibitors
-
Orphan Drug Status
No
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- No development reported Alzheimer's disease
Most Recent Events
- 15 Feb 2024 Discontinued - Phase-II for Alzheimer's disease in Canada (SC) (Roche pipeline, February 2024)
- 15 Feb 2024 Discontinued - Phase-II for Alzheimer's disease in Colombia (IV) (Roche pipeline, February 2024)
- 15 Feb 2024 Discontinued - Phase-II for Alzheimer's disease in Colombia (SC) (Roche pipeline, February 2024)
Development Overview
Introduction
Crenezumab is a humanised monoclonal IgG4 antibody against human 1-40 and 1-42 beta amyloid, being developed by AC Immune Ltd and Genentech (a subsidiary of Roche) for Alzheimer's disease (AD). Crenezumab's preferential binding of oligomeric amyloid-beta species underlies its unique mechanism of action. The antibody targets monomeric and aggregated forms of amyloid-ß, and displays highest affinity for neurotoxic oligomers. An intravenous formulation of crenezumab is under clinical development in countries worldwide. Clinical development of a subcutaneous formulation is ongoing in Canada, Colombia, France, Germany, Spain, USA and UK.
Crenezumab is a lead candidate identified by AC Immune from a research programme to develop anti-Aβ monoclonal antibodies for AD treatment. AC Immune developed conformation specific antibodies against Aβ, a protein implicated in the pathogenesis of AD, through use of its SupraAntigen™ technology. Crenezumab was licensed to Genentech in 2006.
However, in February 2024, crenezumab was removed from the company pipeline, therefore, it appears that phase II development has been discontinued for Alzheimer's disease.
A of February 2023, no recent reports of development have been identified for phase III trials for Alzheimer's disease in the USA, Argentina, Austria, Australia, Belgium, Brazil, Bulgaria, Canada, Costa Rica, Croatia, Czech Republic, China, Denmark, Estonia, Finland, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, South Korea, Lithuania, Mexico, Norway, Peru, Poland, Portugal, Russia, Serbia, Slovenia, Spain, South Africa, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom (IV)
Company Agreements
In December 2006, AC Immune, Ltd. entered into an exclusive global license agreement and research collaboration with Genentech, Inc. for the development of anti-beta-amyloid antibodies for the potential treatment of Alzheimer′s Disease and other human diseases. Under the terms of this agreement, Genentech will make an upfront payment to AC Immune, with the potential for a total of over $US300 million in payments upon successful completion of clinical and regulatory milestones for Alzheimer′s and additional applications. Upon commercialization of a product, Genentech will pay AC Immune royalties on net sales of AC Immune′s antibodies in the field of Alzheimer′s or other human applications. Genentech will also provide funding for a multi-year collaborative research program and will cover all development and clinical costs of the lead antibody and subsequent antibody candidates. [1]
Key Development Milestones
According to Roche's pipeline as of February 2021, regulatory filings for crenezumab in treatment of Alzheimer's disease are expected post 2023.
In July 2020, Roche discontinued the phase III CREAD OLE trial due to an interim analysis in the BN29552 study, which indicated that crenezumab was unlikely to meet its primary endpoint (BN40031; EudraCT2017-002702-12; NCT03491150). The open-label study that was initiated in April 2018 to evaluate the safety and efficacy patients of long-term crenezumab IV infusion in patients with Alzheimer's disease. The trial enrolled 149 patients in Australia, Canada, Finland, France, Germany, Hong Kong, Italy, South Korea, Lithuania, Mexico, Poland, Russia, Spain, Turkey, the UK, the US, Sweden, Denmark, Hungary, and Belgium [2] .
Genentech, in January 2019 discontinued its phase III CREAD 1 trial of crenezumab that evaluated efficacy and safety of crenezumab IV infusion in participants with prodromal-to-mild Alzheimer's disease (BN29552; NCT02670083). The decision resulted from the recommendation of an independent Data Safety Monitoring Board (DSMB), based on a pre-planned interim analysis of efficacy and safety, which indicated that crenezumab was unlikely to meet the primary endpoint of change in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score baseline to week 105. The randomised, double-blind, placebo-controlled trial was initiated in March 2016, enrolled 813 patients in the US, Australia, Austria, Belgium, Bulgaria, Canada, Costa Rica, Croatia, the Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, Italy, South Korea, Lithuania, Mexico, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and the UK. Earlier, the recruitment in the trial was completed in the fourth quarter of 2017. In February 2017, the company reported that results from a phase Ib dose-escalation study and an exposure-response model supports the 60mg/kg dose in the trial. [3] [4] [5] [6] [7] [8] .
Genentech, in January 2019 discontinued its phase III CREAD 2 trial of crenezumab that evaluated efficacy and safety of crenezumab IV infusion in participants with prodromal-to-mild Alzheimer's disease (BN29553; EudraCT2016-003288-20; NCT03114657).The decision resulted from the recommendation of an independent Data Safety Monitoring Board (DSMB), based on a pre-planned interim analysis of efficacy and safety, which indicated that crenezumab was unlikely to meet the primary endpoint of change from baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score. Earlier, recruitment in the trial was completed in July 2018.The randomised, double-blind, placebo-controlled trial was initiated in March 2017 and enrolled 750 patients across Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Estonia, France, Germany, Israel, Italy, Japan, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Russia, Serbia, Slovakia, South Africa, Spain, Taiwan, Turkey, United Kingdom and the US [3] [4] [9] .
In April 2022, Genentech completed a phase II trial which evaluated the effect of crenezumab on the longitudinal tau burden in a subgroup of preclinical Presenilin1 (PSEN1) E280A mutation carriers and non-carriers, who were enrolled in study NCT01998841 (GN28352) (NCT03977584; BN40199). Participants received up to three intravenous (IV) injections of [^18F] Genentech Tau Probe 1 (GTP1) and underwent a tau positron emission tomography (PET) scan after each IV injection of [18^F]GTP1. The purpose of this substudy was to increase the understanding of disease progression in the preclinical stage of familial Alzheimer's Disease (AD). The double-blind, randomised trial initiated in June 2019, enroled 150 patients in Colombia [10] [11] .
As at July 2023, Genentech completed a phase II clinical trial that investigated the efficacy of crenezumab SC for the prevention of Alzheimer's disease in cognitively healthy participants who have a genetic predisposition to develop the disease (NCT01998841; GN28352).The double-blind trial was initiated in November 2013 and enrolled 252 patients, aged 30-60 years, in Colombia who have a genetic mutation that typically leads to the early onset of Alzheimer's disease symptoms. In December 2013, the first drug doses were administered to study participants [12] [13] [14] . PRA, a clinical research organisation, announced its participation in this trial in July 2012 [15] [16] . In June 2022, data from the trial was released by Genentech, which indicated that crenezumab did not prevent progression to dementia in cognitively healthy people at genetically high risk for developing Alzheimer’s disease [17] . In August 2022, updated efficacy data from the trial were released by the company [18] . In July 2022, results from the trial were presented at Alzheimer's Association International Conference 2022 (AAIC-2022) [19] . In July 2023, Genentech presented results from the trial at the Alzheimer's Association International Conference 2023 (AAIC-2023) [20]
In February 2017, Genentech completed a long-term safety and tolerability extension phase II trial of crenezumab in patients with mild to moderate Alzheimer's disease and who participated in and completed the BLAZE or ABBY trials (EudraCT2012-003242-33; NCT01723826; UKCRN13360; DeNDRoN066ext; GN28525). The trial was initiated in November 2012 and enrolled 360 patients in the US, Canada, France, Germany, Spain and the UK [21] .
Genentech completed the phase II BLAZE biomarker trial of crenezumab in patients with Alzheimer's disease in April 2014 (ABE4955g; NCT01397578). The primary endpoint of the trial was the change in brain amyloid load from baseline to week 69. The trial recruited 91 patients at sites in the US, France and Spain. The company reported data from this trial at the Alzheimer's Association International Conference (AAIC-2014) [22] [23] . The pooled analysis results from the ABBY and BLAZE phase II trials were presented at the Alzheimer's Association International Conference (AAIC-2018) [24] [25] .
In February 2014, Genentech completed the randomised, double-blind, placebo-controlled phase II ABBY trial that assessed the safety and efficacy of intravenous and subcutaneous formulations of crenezumab in patients with mild to moderate Alzheimer's disease (ABE4869g; NCT01343966). This 73-week trial enrolled 450 patients at sites in the US, Canada, France, Germany, Spain and the UK. Initiation of the trial triggered a milestone payment to AC Immune. In July 2014, the company reported that the trial failed to meet its co-primary endpoints and these data were presented at the Alzheimer's Association International Conference (AAIC-2014) [22] [26] .
In March 2016, Chugai Pharmaceutical initiated a long-term phase I trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of crenezumab IV infusion in patients with Alzheimer's disease (JapicCTI-163210). The placebo-controlled trial will enrol approximately eight patients in Japan [27] .
In June 2017, Genentech completed a phase Ib trial that investigated the safety and tolerability of intravenous crenezumab, in patients with mild to moderate Alzheimer's disease (GN29632; NCT02353598). The randomised, placebo-controlled, double-blind, trial was initiated in January 2015, and enrolled 77 patients in the US [28] . In December 2016, results from the trial were reported by the company. These safety and pharmacokinetic data of the study support the continued treatment of patients with crenezumab at a higher dose of 60mg/kg. An optional open-label extension portion, after completion of the double blind portion of the study, will be offered to patients [29] .
In July 2015, Genentech completed a phase I trial that assessed the relative bioavailability and tolerability of two formulations of crenezumab in healthy volunteers following subcutaneous administration (GP29172, NCT02427243). The single-dose, randomised, open-label, parallel group study was initiated in April 2015, that enrolled 60 volunteers in the US [30] .
Genentech completed a phase I trial of crenezumab in patients with mild-to-moderate AD in May 2010 (ABACUS; NCT00736775). The trial included 56 subjects, who were recruited at several sites throughout the US. Crenezumab was given as single and multiple IV doses. The enrolment of the first patient in the phase I trial triggered a milestone payment of an undisclosed amount to AC Immune by Genentech [31] [32] .
In May 2010, Genentech completed a phase I trial of subcutaneous and intravenous formulations of crenezumab in healthy subjects in the US (NCT00997919). The trial evaluated the safety, tolerability, pharmacokinetics and bioavailability of single doses of the drug [33] .
In October 2018, AC Immune released in vitro data that underscored the clinical rationale for crenezumab, as a potential therapy for treating Alzheimer's disease [34] .
Financing Information
In May 2012, the landmark trial was announced by the Alzheimer's Prevention Initiative (API), which is an international collaboration involving Genentech, the US National Institutes of Health (NIH), the Banner Alzheimer′s Institute (BAI), and the University of Antioquia in Colombia (NCT01998841; GN28352). The $US100 million study is funded primarily by Genentech, and by a 5-year $US16 million grant from the US NIH, and a $US15 million grant from the BAI [12] [13] . PRA, a clinical research organisation, announced its participation in this trial in July 2012 [15] . This research was funded in part by NIH grants RF1AG041705 and R01AG055444 from the National Institute on Aging, the primary US federal agency supporting and conducting Alzheimer's disease research [35] .
Patent Information
As at December 2021, AC Immune has 49 patent applications and and 15 patent applications in 34 countries, owned or co-owned for crenezumab that cover the its composition of matter which includes candidate's antibody or a fragment thereof, a polynucleotide encoding the crenezumab antibody or a fragment thereof, a cell line used to produce the crenezumab antibody as well as pharmaceutical compositions comprising the crenezumab antibody. The patents also cover the drug's ability to treat certain indications including Alzheimier's disease and method of manufacturing of the drug, which are expected to expire in 2027 [36] [37] .
Crenezumab is protected under US Patent US7 892 544, which was filed June 12, 2007 [38] .
Drug Properties & Chemical Synopsis
- Route of administration IV, SC
- Formulation Infusion, Injection
- Class Antibodies, Antidementias, Monoclonal antibodies
- Target Amyloid beta-protein
- Mechanism of Action Amyloid beta-protein inhibitors
-
WHO ATC code
N06D (Anti-Dementia Drugs)
N07 (Other Nervous System Drugs)
-
EPhMRA code
N7D (Anti-Alzheimer Products)
- Chemical name Immunoglobulin G4, anti-(human 1-40-β-amyloid/human 1-42-β-amyloid)(human-mouse monoclonal MABT5102A heavy chain), disulfide with human-mouse monoclonal MABT5102A light chain, dimer
- Molecular formula C6348 H9796 N1688 O2010 S44
- CAS Registry Number 1095207-05-8
Biomarkers Sourced From Trials
| Indication | Biomarker Function | Biomarker Name | Number of Trials |
|---|---|---|---|
|
Alzheimer's disease |
Outcome Measure |
SERPINF2 Ataxia telangiectasia mutated Amyloid beta precursor protein (APP) |
|
|
Alzheimer's disease |
Brief Title |
PSEN1 |
|
|
Alzheimer's disease |
Eligibility Criteria |
TNF alpha induced protein 1 Thyroid stimulating hormone beta (TSH) PSEN1 NADH dehydrogenase (ubiquinone) 1 beta subcomplex, 3, 12kDa Cyanocobalamin Cobalamin ApoE |
|
|
Alzheimer's disease |
Official Title |
PSEN1 |
|
|
Alzheimer's disease |
Brief Summary |
PSEN1 |
Biomarker
| Drug Name | Biomarker Name | Biomarker Function |
|---|---|---|
| Crenezumab - AC Immune/Genentech/Universidad-de-Antioquia | Amyloid beta precursor protein (APP) | Outcome Measure |
| ApoE | Eligibility Criteria | |
| Ataxia telangiectasia mutated | Outcome Measure | |
| Cobalamin | Eligibility Criteria | |
| Cyanocobalamin | Eligibility Criteria | |
| NADH dehydrogenase (ubiquinone) 1 beta subcomplex, 3, 12kDa | Eligibility Criteria | |
| PSEN1 | Brief Summary, Brief Title, Eligibility Criteria, Official Title | |
| SERPINF2 | Outcome Measure | |
| Thyroid stimulating hormone beta (TSH) | Eligibility Criteria | |
| TNF alpha induced protein 1 | Eligibility Criteria |
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| Alzheimer's disease | - | - | No development reported (III) | Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Russia, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey, USA, Ukraine, United Kingdom | IV / Infusion | Genentech | 22 Feb 2023 |
| Alzheimer's disease | - | - | No development reported (III) | Switzerland | IV / Infusion | AC Immune, Genentech | 22 Feb 2021 |
| Alzheimer's disease | - | - | Discontinued (II) | Canada, France, Germany, Spain, USA, United Kingdom | SC / Injection | AC Immune | 15 Feb 2024 |
| Alzheimer's disease | - | - | Discontinued (II) | Colombia | SC / Injection | Universidad de Antioquia | 15 Feb 2024 |
| Alzheimer's disease | - | - | Discontinued (II) | Colombia | IV / Infusion | Universidad de Antioquia | 15 Feb 2024 |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| Universidad de Antioquia | Originator | Colombia |
| AC Immune | Originator | Switzerland |
| AC Immune | Owner | Switzerland |
| Universidad de Antioquia | Owner | Colombia |
| Genentech | Licensee | USA |
| National Institutes of Health (USA) | Funder | USA |
| Banner Alzheimers Institute | Funder | USA |
| Chugai Pharmaceutical | Collaborator | Japan |
Credit Suisse Market Status
| Indication | Region | Company | Phase | Expected Launch Year | Probability of Success% | Patent Expiry Year | Expected Generic Entry | Last Update |
|---|---|---|---|---|---|---|---|---|
| Alzheimer's | Wrld (50% US) | AC Immune | Development Stopped | - | - | - | - | 05 Nov 2023 |
Scientific Summary
Pharmacokinetics
Results from a phase Ib trial of crenezumab in 52 patients with mild-to-moderate Alzheimer's disease demonstrated that the pharmacokinetic profile of crenezumab was dose proportional up to the 60 mg/kg dose and was consistent with historical data. The serum concentrations at this dose was four fold higher than in the 15 mg/kg IV every four weeks [29] [28] .
Adverse Events
Clinical
overall rate of adverse events (AEs) was similar in patients, with mild-to-moderate Alzheimer's disease (AD), treated with crenezumab or placebo in the phase II ABBY and BLAZE trials (NCT01343966 and NCT01397578, respectively). AEs were observed in 91.3% and 90.3% of the patients in crenezumab and placebo arms, respectively, and were transient and mild-to-moderate. The percentage of patients developing pneumonia were 3.2% and 0.6% in the respective arms, and there was an imbalance in the overall rate of non-serious and serious pneumonia events. Five deaths unrelated to treatment with crenezumab were reported in total in the two trials and the overall death rate was consistent with the background rate in elderly AD patients. One patient treated with high dose intravenous (IV) crenezumab, in the ABBY trial, showed asymptomatic amyloid-related imaging abnormalities. The ABBY study randomised 431 patients with a baseline mini-mental state examination (MMSE) score of 18-26 to 15mg/kg crenezumab every 4 weeks (high dose) or 300mg of subcutaneous (SC) crenezumab every other week or matching placebo arms for 68 weeks. The BLAZE trial randomised 91 patients with baseline MMSE score of 18-26 and a positive PET scan for amyloid to receive 15mg/kg IV crenezumab every four weeks or 300mg of SC crenezumab every other week for 68 weeks or matching placebos. Patients were followed for 73 weeks in both the trials [22] .
No dose-limiting toxicities were observed at 30, 45 and 60 mg/kg doses of crenezumab during the first two cohorts of a phase Ib trial in 52 patients with mild-to-moderate Alzheimer's disease. No events of Amyloid Related Imaging Abnormality-Oedema (ARIA-E) were observed and six patients showed asymptomatic Amyloid Related Imaging Abnormality-Hemsiderin (ARIA-H) which did not result in treatment discontinuation [29] [28] .
In phase II study of crenezumab for treatment of Alzheimer’s Disease no new safety issues were identified during the study [17] [13]
Pharmacodynamics
Summary
In vivo
studies in a human-induced pluripotent stem cell (iPSC) neuronal model demonstrated that neurons were protected by crenezumab from synaptic loss, tau phosphorylation, and neuronal death in a concentration-dependent manner [34] .
Therapeutic Trials
Crenezumab treatment did not show significant reduction in cognitive and global functional decline, the co-primary endpoints, in patients with mild-to-moderate Alzheimer's disease (AD), compared with treatment with placebo in the phase II ABBY trial (NCT01343966). Reduction in cognitive and global functional decline were measured by ADAS-Cog12 and CDR-SOB, respectively. High-dose intravenous (IV) crenezumab changed cognitive and global functional decline by 16.8 % (p = 0.19) and a 3.1% (p = 0.85), respectively. At all time points over the 18-month treatment period, rates of decline on ADAS-Cog12 were lower in patients treated with IV crenezumab compared with placebo. Low-dose subcutaneous (SC) crenezumab did not show significant reduction in cognitive measures. Patients with mild AD and treated with high-dose IV crenezumab demonstrated a 23.8% reduction (p = 0.13) in cognitive decline, in a pre-specified subgroup analysis, however not in global functional decline (-1.0%; p = 0.96). In an exploratory analysis in patients with milder symptoms, reduction in cognitive and global functional decline were 35.4% (p = 0.036) and 19.6% (p = 0.42). The study randomised 431 patients with a baseline mini-mental state examination (MMSE) score of 18-26 to 15mg/kg crenezumab every 4 weeks (high dose) or 300mg of SC crenezumab every other week or matching placebo arms for 68 weeks, and patients were followed from baseline to 73 weeks. Patients with MMSE score of 20-26 and 22-26 were defined as having mild AD and AD patients with milder symptoms, respectively [39] [22] [26] .
No significant reduction in cognitive and global functional decline was observed in patients with mild-to-moderate AD compared with those treated with placebo in the phase II BLAZE trial (NCT01397578). Treatment with high dose IV crenezumab showed a 10.3% (p = 0.84) and 7.4% (p = 0.84) reduction in cognitive and global functional decline, respectively, and no significant changes in cognitive measures were observed with low-dose SC crenezumab. A 52.0% (p = 0.29) and 41.5% (p = 0.44) reduction was observed in cognitive and global functional decline in patients with mild AD, in a post-hoc analysis. The trial randomised 91 patients with baseline MMSE score of 18-26 and a positive PET scan for amyloid to receive 15mg/kg IV crenezumab every four weeks or 300mg of SC crenezumab every alternate week for 68 weeks or matching placebos, and patients were followed from baseline to 73 weeks. Patients were stratified using MMSE scores as in the ABBY trial [22] [23] .
Updated data from a phase II study of crenezumab in patients with Alzheimer’s disease, showed that the use of pons for 2-year and cerebral white matter (WM) or pons reference region (RR) for 5-year changes may improve the power to track longitudinal increases and evaluate Aß-modifying treatments in 2 and 5-year studies, in the Autosomal Dominant Alzheimer’s Disease (ADAD) population. The analysis evaluated template-based (SPM12) cortical mean change using baseline, 2, and 5-year florbetapir PET standard-uptake value ratios (SUVRs) with three different RRs (whole cerebellum, pons, and WM) and compared carriers on placebo (placebo-carriers, n=82) with NC all on placebo (NC, n=83). Placebo-carriers had significantly greater standard-uptake value ratios (SUVR) change as compared with non-carriers (NC) for all three reference regions. The reference region of the pons was best at detecting 2-year changes =1.75[1.39-2.11]), and WM and pons were best at detecting 5-year changes in cortical-Aß levels between placebo-carriers and non-carriers (pons >=2.01[1.64-2.39], WM>=2.51[2.10-2.92]). Treatment-carriers had higher cerebellar-to-pons-SUVRs compared with placebo-carriers at baseline and 2-years, but not 5-years (p=.034, p=.027,& p=0.06,respectively). Both carrier groups had higher cerebellar-to-pons-SUVRs compared to non-carriers at each interval. Cerebellar-to-pons-SUVRs continued to increase within carrier groups at each interval and remained constant within the non-carrier-group [20] . Earlier results from phase II study of crenezumab for treatment of Alzheimer’s Disease did not demonstrate a statistically significant clinical benefit in either of its co-primary endpoints assessing the rate of change in cognitive abilities or episodic memory function, measured by the API ADAD composite cognitive score and the Free and Cued Selective Reminding Test (FCSRT) Cueing Index, respectively. Small numerical differences favoring crenezumab were observed across the co-primary and multiple secondary and exploratory endpoints, but these were not statistically significant. Crenezumab did not slow or prevent cognitive decline in people with a specific genetic mutation which causes early-onset Alzheimer’s disease. In updated data, clinical endpoints showed the following relative changes in annualized scores compared to placebo, in all cases favoring crenezumab though in all cases not statistically significant. Cognitive test scores measured by API ADAD composite was 22.9% (p = 0.43), FCSRT was 19.9% (p = 0.16) and RBANS total score was 43.8% (p = 0.55). Clinical/function showed that the time to MCI/dementia due to AD was 20.8% (p = 0.48), time to non-Zero in CDR-GS was 8.1% (p = 0.76) and CDR Sum of Boxes was 8.8% (p = 0.64) [18] [17] [13] . Findings from the study indicated that reproductive health data did not differ between carrier and non-carrier females, except for a slightly younger menarcheal age compared to non-carriers, and that menarcheal age may have a very limited impact on brain pathology and function at preclinical stages of ADAD(Autosomal Dominant AD). Carrier and non-carrier females did not differ on number of pregnancies, deliveries, miscarriages, or living children. Female carriers had a significantly younger menarcheal age than non-carriers (12.8 ±1.5 versus 13.7±1.6 years, p = 0.007, Bonferroni). Among carrier females, older menarcheal age was associated with lower scores on the Raven’s test (Bonferroni: r = ‒0.28, p =0.035). Menarcheal age was not associated with scores on the cognitive composite or other individual subtests, or with brain imaging measures [19] .
Pooled Analysis
Results from the pooled analysis of ABBY and BLAZE trials showed that crenezumab reduced Aβ oligomers (AβO) levels in CSF in 104 evaluated patients. Of the total samples analysed, 98 samples had baseline CSF AβO values above the lower limit of quantification (LLoQ). 86% of IV patients and 89% of SC patients had lower levels of abeta oligomers at week 69 than at baseline (p < 0.01 for IV and p < 0.001 for SC vs. placebo) The median change was -42% (p = 0.01) in those treated intravenously (IV) and -48% (p = 0.001) in those treated subcutaneously (SC), with 20% (IV) and 14% (SC) of patients falling below the LLoQ after treatment, respectively. In the placebo group, a median change of -13% and equivalent portions with negative and positive change (54% of the placebo patients had lower AβO levels at week 69) were observed [24] [25] [23] [26] .
Future Events
| Expected Date | Event Type | Description | Updated |
|---|---|---|---|
| 31 Jan 2025 | Regulatory Status | Roche plans to submit regulatory applications for marketing Crenezumab for Alzheimer's disease after 2024 (Roche pipeline, April 2022) | 04 Jul 2022 |
| 31 Dec 2017 | Trial Update | Genentech plans a phase III CREAD2 trial for Alzheimer's disease [6] | 13 Apr 2017 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 15 Feb 2024 | Phase Change - Discontinued(II) | Discontinued - Phase-II for Alzheimer's disease in Canada (SC) (Roche pipeline, February 2024) Updated 26 Feb 2024 |
| 15 Feb 2024 | Phase Change - Discontinued(II) | Discontinued - Phase-II for Alzheimer's disease in Colombia (IV) (Roche pipeline, February 2024) Updated 26 Feb 2024 |
| 15 Feb 2024 | Phase Change - Discontinued(II) | Discontinued - Phase-II for Alzheimer's disease in Colombia (SC) (Roche pipeline, February 2024) Updated 26 Feb 2024 |
| 15 Feb 2024 | Phase Change - Discontinued(II) | Discontinued - Phase-II for Alzheimer's disease in France (SC) (Roche pipeline, February 2024) Updated 26 Feb 2024 |
| 15 Feb 2024 | Phase Change - Discontinued(II) | Discontinued - Phase-II for Alzheimer's disease in Germany (SC) (Roche pipeline, February 2024) Updated 26 Feb 2024 |
| 15 Feb 2024 | Phase Change - Discontinued(II) | Discontinued - Phase-II for Alzheimer's disease in Spain (SC) (Roche pipeline, February 2024) Updated 26 Feb 2024 |
| 15 Feb 2024 | Phase Change - Discontinued(II) | Discontinued - Phase-II for Alzheimer's disease in United Kingdom (SC) (Roche pipeline, February 2024) Updated 26 Feb 2024 |
| 15 Feb 2024 | Phase Change - Discontinued(II) | Discontinued - Phase-II for Alzheimer's disease in USA (SC) (Roche pipeline, February 2024) Updated 26 Feb 2024 |
| 22 Jan 2024 | Licensing Status | AC Immune and Genentech plans to terminate licence agreement for Crenezumab in Alzheimer′s disease Updated 28 Jan 2024 |
| 05 Nov 2023 | Financial Update | Credit Suisse financial data update Updated 05 Nov 2023 |
| 16 Jul 2023 | Trial Update | Genentech completes a phase II trial in Alzheimer's disease in Colombia (SC) (IV) (NCT01998841) [20] Updated 21 Sep 2023 |
| 16 Jul 2023 | Scientific Update | Efficacy data from a phase II trial in Alzheimer's disease presented at the Alzheimer's Association International Conference 2023 (AAIC-2023) [20] Updated 28 Aug 2023 |
| 22 Feb 2023 | Phase Change - No development reported(III) | No development reported - Phase-III for Alzheimer's disease in USA, Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Hong Kong, Hungary, Italy, Japan, South Korea, Lithuania, Mexico, Poland, Russia, Spain, Sweden, Turkey, Ukraine, Ukraine, United Kingdom (IV) (NCT02670083) Updated 22 Feb 2023 |
| 22 Feb 2023 | Trial Update | No recent reports of development identified - Phase-III for Alzheimer's disease in Australia, Belgium, Canada, Denmark, France, Germany, South Korea, Poland, Portugal, Russia, Spain, Sweden, United Kingdom, Italy (IV) (NCT03114657) Updated 22 Feb 2023 |
| 02 Aug 2022 | Scientific Update | Updated efficacy data from a phase II trials for Alzheimer's disease was released by AC Immune [18] Updated 05 Aug 2022 |
| 31 Jul 2022 | Scientific Update | Efficacy data from the phase II trials for Alzheimer's disease was presented at Alzheimer's Association International Conference 2022 (AAIC-2022) [19] Updated 16 Sep 2022 |
| 16 Jun 2022 | Scientific Update | Safety and efficacy data from the phase II trials for Alzheimer's disease was released by Genentech [17] Updated 17 Jun 2022 |
| 25 Apr 2022 | Regulatory Status | Roche plans to submit regulatory applications for marketing Crenezumab for Alzheimer's disease after 2024 (Roche pipeline, April 2022) Updated 04 Jul 2022 |
| 19 Apr 2022 | Trial Update | Genentech completes a phase II trial for Alzheimer's disease in Colombia (IV) (SC) (NCT03977584) Updated 02 Jun 2022 |
| 01 Oct 2021 | Biomarker Update | Biomarkers information updated Updated 02 Oct 2021 |
| 06 Jul 2021 | Patent Information | AC Immune has patent protection for crenezumab in unknown countries [37] [36] Updated 07 Jul 2021 |
| 06 Jul 2021 | Patent Information | AC Immune has patent protection for crenezumab in USA [38] [36] Updated 07 Jul 2021 |
| 22 Feb 2021 | Phase Change - No development reported(III) | No recent reports of development identified - Phase-III for Alzheimer's disease in Bulgaria, Costa Rica, Croatia, Czech Republic, Portugal, Slovenia, Switzerland (IV) (NCT02670083) Updated 22 Feb 2021 |
| 22 Feb 2021 | Phase Change - No development reported(III) | No recent reports of development identified - Phase-III for Alzheimer's disease in Serbia, Argentina, Brazil, Chile, China, Estonia, Israel, Japan, Slovakia, Netherlands, Peru, South Africa, Taiwan, Norway (IV) (NCT03114657) Updated 22 Feb 2021 |
| 13 Jul 2020 | Trial Update | Roche terminates the phase III CREAD OLE trial in Alzheimer's disease in Australia, Canada, Finland, France, Germany, Hong Kong, Italy, South Korea, Lithuania, Mexico, Poland, Russia, Spain, Turkey, United Kingdom, USA, Sweden, Denmark, Hungary, Belgium (NCT03491150) (EudraCT2017-002702-12) Updated 22 Jul 2020 |
| 04 May 2020 | Trial Update | AC Immune temporarily halts a phase II trial in Alzheimer's disease due to COVID-2019 pandemic in the US [14] Updated 07 May 2020 |
| 30 Jun 2019 | Trial Update | Genentech initiates a phase II trial for Alzheimer's disease in Colombia (IV) (SC) (NCT03977584) Updated 29 Aug 2019 |
| 06 Jun 2019 | Trial Update | Genentech plans a phase II trial for Alzheimer's disease in June 2019 (NCT03977584) Updated 11 Jun 2019 |
| 29 Jan 2019 | Trial Update | Genentech discontinues the phase III CREAD1 and CREAD2 trials in Alzheimers disease in Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Costa Rica, Chile, China, Colombia, Croatia, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Hong Kong, Hungary, Italy, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Russia, Slovenia, Serbia, Slovakia, Spain, South Korea, Sweden, Switzerland, South Africa, Spain, Taiwan Turkey, Ukraine, the UK and the US due to unfavorable efficacy results [3] Updated 01 Feb 2019 |
| 29 Oct 2018 | Scientific Update | Pharmacodynamics data from an in vitro study in Alzheimer's disease released by AC Immune [34] Updated 02 Nov 2018 |
| 25 Jul 2018 | Scientific Update | Efficacy data from the ABBY and BLAZE phase II trials for Alzheimer's disease released by AC Immune [25] Updated 26 Jul 2018 |
| 22 Jul 2018 | Scientific Update | Updated efficacy data from the ABBY and BLAZE phase II trials for Alzheimer's disease presented at the Alzheimer's Association International Conference (AAIC-2018) [24] Updated 08 Oct 2018 |
| 17 Jul 2018 | Trial Update | Roche completes enrolment in the phase III CREAD 2 trial for Alzheimer's disease in Brazil, Chile, Argentina, China, England, Estonia, Israel, Japan, Norway, Peru, Scotland, Serbia, South Africa, Spain, Taiwan, Slovakia, Norway, Netherlands (EudraCT2016-003288-20; NCT03114657) Updated 23 Jul 2018 |
| 11 Apr 2018 | Trial Update | Roche initiates enrolment in the phase III CREAD OLE trial for Alzheimer's disease in Australia, Canada, Finland, France, Germany, Hong Kong, Italy, South Korea, Lithuania, Mexico, Poland, Russia, Spain, Turkey, United Kingdom, Sweden, Denmark, Hungary, Belgium(NCT03491150) Updated 22 Jul 2020 |
| 11 Apr 2018 | Trial Update | Roche initiates enrolment in the phase III CREAD OLE trial for Alzheimer's disease in the US and extend to Australia and Canada (NCT03491150) Updated 12 Apr 2018 |
| 31 Dec 2017 | Trial Update | Roche completes enrolment in the phase III CREAD 1 trial for Alzheimer's disease in Australia, Austria, Belgium, Bulgaria, Canada, Costa Rica, Croatia, the Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, Italy, South Korea, Lithuania, Mexico, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom and USA (NCT02670083) Updated 23 Jul 2018 |
| 26 Jun 2017 | Trial Update | Genentech completes a phase I trial in Alzheimer's disease in USA (NCT02353598) Updated 03 Aug 2017 |
| 21 Mar 2017 | Phase Change - III | Phase-III clinical trials in Alzheimer's disease in Brazil, Chile, Argentina, China, England, Estonia, Israel, Japan, Norway, Peru, Scotland, Serbia, South Africa, Taiwan, Slovakia, Norway, Netherlands (IV) after March 2017 (EudraCT2016-003288-20; NCT03114657) Updated 23 Jul 2018 |
| 21 Mar 2017 | Trial Update | Roche initiates the phase III CREAD 2 trial in Alzheimer's disease in Spain (EudraCT2016-003288-20; NCT03114657) Updated 04 Apr 2017 |
| 28 Feb 2017 | Trial Update | Genentech plans a phase III CREAD2 trial for Alzheimer's disease [6] Updated 13 Apr 2017 |
| 01 Feb 2017 | Trial Update | Genentech completes a phase II long-term safety extension trial for Alzheimer's disease in USA, Canada, France, Germany, Spain and United Kingdom (IV) (NCT01723826) Updated 11 May 2017 |
| 15 Dec 2016 | Scientific Update | Adverse events and pharmacokinetics data from a phase I trial in Alzheimer's disease released by AC Immune [29] Updated 15 Dec 2016 |
| 22 Mar 2016 | Phase Change - III | Phase-III clinical trials in Alzheimer's disease in Australia, Austria, Belgium, Bulgaria, Costa Rica, Czech Republic, Croatia, Denmark, Finland, Hong Kong, Hungary, Italy, South Korea, Lithuania, Mexico, Poland, Portugal, Russia, Slovenia, Sweden, Turkey, Ukraine (IV) (NCT02670083) Updated 04 Apr 2017 |
| 22 Mar 2016 | Phase Change - III | Phase-III clinical trials in Alzheimer's disease in Canada, France, Germany, Spain, United Kingdom, Switzerland (IV) (NCT02670083) Updated 04 Apr 2017 |
| 01 Mar 2016 | Phase Change - I | Phase-I clinical trials in Alzheimer's disease in Japan (IV) (JapicCTI-163210) Updated 22 Jun 2016 |
| 01 Jan 2016 | Phase Change - III | Phase-III clinical trials in Alzheimer's disease in USA (IV) (NCT02670083) Updated 12 Feb 2016 |
| 13 Aug 2015 | Trial Update | Roche plans a phase III trial for Alzheimer's disease [7] Updated 13 Aug 2015 |
| 20 Jul 2015 | Active Status Review | Crenezumab is still in phase II trials for Alzheimer's disease in the USA, Canada, France, Germany, Spain and United Kingdom (IV & SC) Updated 20 Jul 2015 |
| 01 Jul 2015 | Trial Update | Genentech completes a phase I trial in Volunteers in USA (SC, Injection) (NCT02427243) Updated 22 Mar 2016 |
| 01 Apr 2015 | Trial Update | Genentech initiates phase I trial in Volunteers in USA (SC, Injection)(NCT02427243) Updated 06 May 2015 |
| 30 Jan 2015 | Trial Update | Genentech initiates a phase I trial for Alzheimer's disease in USA (NCT02353598) Updated 07 Feb 2015 |
| 16 Jul 2014 | Scientific Update | Efficacy and adverse events data from the phase II ABBY and BLAZE trials in Alzheimer's disease presented at the Alzheimer's Association International Conference (AAIC-2014) [22] Updated 01 Sep 2014 |
| 01 Apr 2014 | Trial Update | Genentech completes the BLAZE trial for Alzheimer's disease in USA, France and Spain (NCT01397578) Updated 19 Jun 2014 |
| 01 Feb 2014 | Trial Update | Genentech completes the phase II ABBY trial for Alzheimer's disease in Canada, France, Germany, Spain, the United Kingdom and the USA (NCT01343966) Updated 16 May 2014 |
| 30 Nov 2013 | Phase Change - II | Phase-II clinical trials in Alzheimer's disease in Colombia (SC) (IV) (NCT01998841) Updated 10 Dec 2013 |
| 23 May 2013 | Trial Update | Genentech completes enrolment in the ABBY trial for Alzheimer's disease in Canada, France, Germany, Spain, the United Kingdom and the USA (NCT01343966) Updated 10 Dec 2013 |
| 23 May 2013 | Trial Update | Genentech completes enrolment in the BLAZE trial for Alzheimer's disease in USA, France and Spain (NCT01397578) Updated 10 Dec 2013 |
| 01 Nov 2012 | Trial Update | Genentech initiates enrolment in a phase II long-term safety extension trial for Alzheimer's disease in USA, Canada, France, Germany, Spain and United Kingdom (NCT01723826) (EudraCT2012-003242-33) Updated 08 Jan 2013 |
| 15 May 2012 | Company Involvement | Genentech establishes a collaboration with the US National Institutes of Health and the Banner Alzheimer's Institute for the development of crenezumab for prevention of Alzheimer's disease [12] Updated 17 May 2012 |
| 15 May 2012 | Phase Change - II | Phase-II clinical trials in Alzheimer's disease (prevention) in USA (IV) Updated 17 May 2012 |
| 15 May 2012 | Trial Update | Genentech and collaborators plan a landmark trial for the prevention of Alzheimer's disease in Colombia and USA [12] Updated 17 May 2012 |
| 09 Apr 2012 | Phase Change - II | Phase-II clinical trials in Alzheimer's disease in Canada (IV) Updated 17 May 2012 |
| 09 Apr 2012 | Phase Change - II | Phase-II clinical trials in Alzheimer's disease in Canada (SC) Updated 17 May 2012 |
| 09 Apr 2012 | Phase Change - II | Phase-II clinical trials in Alzheimer's disease in France (IV) Updated 17 May 2012 |
| 09 Apr 2012 | Phase Change - II | Phase-II clinical trials in Alzheimer's disease in France (SC) Updated 17 May 2012 |
| 09 Apr 2012 | Phase Change - II | Phase-II clinical trials in Alzheimer's disease in Germany (IV) Updated 17 May 2012 |
| 09 Apr 2012 | Phase Change - II | Phase-II clinical trials in Alzheimer's disease in Germany (SC) Updated 17 May 2012 |
| 09 Apr 2012 | Phase Change - II | Phase-II clinical trials in Alzheimer's disease in Spain (IV) Updated 17 May 2012 |
| 09 Apr 2012 | Phase Change - II | Phase-II clinical trials in Alzheimer's disease in Spain (SC) Updated 17 May 2012 |
| 09 Apr 2012 | Phase Change - II | Phase-II clinical trials in Alzheimer's disease in United Kingdom (IV) Updated 17 May 2012 |
| 09 Apr 2012 | Phase Change - II | Phase-II clinical trials in Alzheimer's disease in United Kingdom (SC) Updated 17 May 2012 |
| 17 Aug 2011 | Trial Update | Roche initiates enrolment in the phase II BLAZE trial for Alzheimer's disease in USA (NCT01397578) Updated 03 Nov 2011 |
| 30 Apr 2011 | Phase Change - II | Phase-II clinical trials in Alzheimer's disease in USA (IV) Updated 15 Jun 2011 |
| 30 Apr 2011 | Phase Change - II | Phase-II clinical trials in Alzheimer's disease in USA (SC) Updated 15 Jun 2011 |
| 31 May 2010 | Trial Update | Genentech completes a phase I trial in Alzheimer's disease in USA (IV) Updated 18 Nov 2010 |
| 30 Nov 2009 | Phase Change - I | Phase-I clinical trials in Alzheimer's disease in USA (SC) Updated 01 Jun 2010 |
| 21 Aug 2008 | Phase Change - I | Phase-I clinical trials in Alzheimer's disease in USA (IV) Updated 21 Aug 2008 |
| 25 Mar 2008 | Active Status Review | Preclinical development is ongoing Updated 25 Mar 2008 |
| 11 Dec 2006 | Phase Change - Preclinical | Preclinical trials in Alzheimer's disease in Switzerland (Parenteral) Updated 11 Dec 2006 |
| 11 Dec 2006 | Phase Change - Preclinical | Preclinical trials in Alzheimer's disease in USA (Parenteral) Updated 11 Dec 2006 |
| 07 Dec 2006 | Licensing Status | AC Immune enters into licence agreement with Genentech for the development of anti-beta-amyloid antibodies in Alzheimer′s disease [1] Updated 28 Jan 2024 |
References
-
Genentech and AC Immune: Exclusive License Agreement.
Media Release -
A Multicenter, Open-Label, Long-Term Extension Of Phase III Studies (BN29552/BN29553) Of Crenezumab In Patients With Alzheimer's Disease
ctiprofile -
Genentech to Discontinue Phase III CREAD 1 and 2 Clinical Studies of Crenezumab in Early Alzheimer's Disease (AD) - Other Company Programs in AD Continue.
Media Release -
Crenezumab's Second Phase 3 Trial (CREAD 2) Fully Recruited - Updates on AC Immune's Pipeline and Technology Platforms to be presented at AAIC in Chicago.
Media Release -
AC IMMUNE REPORTS FULL YEAR 2016 FINANCIAL RESULTS AND R&D UPDATE.
Media Release -
AC IMMUNE PARTNER GENENTECH TO START SECOND PHASE 3 CLINICAL TRIAL FOR ALZHEIMER'S THERAPY CRENEZUMAB.
Media Release -
Roche delivers strong performance in the first half of 2015.
Media Release -
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy And Safety Study of Crenezumab in Patients With Prodromal to Mild Alzheimer's Disease.
ctiprofile -
A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP, EFFICACY AND SAFETY STUDY OF CRENEZUMAB IN PATIENTS WITH PRODROMAL TO MILD ALZHEIMER'S DISEASE
ctiprofile -
AC Immune Reports Q2 2019 Financial Results, Business and Clinical Update.
Media Release -
Tau PET Longitudinal Substudy Associated With: A Double-Blind, Placebo-Controlled Parallel-Group Study in Preclinical PSEN1 E280A Mutation Carriers Randomized to Crenezumab or Placebo, and in Non-randomized, Placebo-treated Non-carriers From the Same Kindred, to Evaluate the Efficacy and Safety of Crenezumab in the Treatment of Autosomal-Dominant Alzheimer's Disease
ctiprofile -
Groundbreaking Alzheimer′s Disease Prevention Trial Announced.
Media Release -
A Double-Blind, Placebo-Controlled Parallel-Group Study in Preclinical PSEN1 E280A Mutation Carriers Randomized to Crenezumab or Placebo, and in Non-Randomized, Placebo-Treated Non-Carriers From the Same Kindred, to Evaluate the Efficacy and Safety of Crenezumab in the Treatment of Autosomal-Dominant Alzheimer's Disease
ctiprofile -
AC Immune Reports Q1 2020 Financial Results and Provides Business Update .
Media Release -
PRA Participates in Landmark Alzheimer's Prevention Clinical Trial.
Media Release -
ALZHEIMER'S PREVENTION INITIATIVE TRIAL MARKS MILESTONE.
Media Release -
Genentech Provides Update on Alzheimers Prevention Initiative Study Evaluating Crenezumab in Autosomal Dominant Alzheimers Disease.
Media Release -
Detailed Data From The Phase II Crenezumab Alzheimer's Prevention Initiative Study In Autosomal Dominant Alzheimer's Disease Presented At AAIC .
Media Release -
Ghisays V, Vila-Castelar C, Giraldo-Chica M, Acosta-Baena N, Protas HD, Malek-Ahmadi MH, et al. Reproductive health data and its relationship to baseline brain imaging and cognitive measurements in cognitively unimpaired female PSEN1 E280A mutation carriers and non-carriers from the API ADAD Trial. AAIC-2022 2022; abstr. P4-186.
Available from: URL: https://alz.confex.com/alz/2022/meetingapp.cgi/Paper/62000 -
Ghisays V, Lopera F, Su Y, Malek-Ahmadi MH, Chen Y, Protas HD, et al. Impact of reference region on longitudinal florbetapir PET SUVR changes from the API ADAD Colombia Trial. AAIC-2023 2023; abstr. P2-854.
Available from: URL: https://alz.confex.com/alz/2023/meetingapp.cgi/Paper/82317 -
A Multicenter, Open-Label, Long-Term Safety Extension of Phase II Studies ABE4869g and ABE4955g in Patients With Mild to Moderate Alzheimer's Disease
ctiprofile -
Roche announces phase II clinical results of crenezumab in Alzheimer's disease.
Media Release -
A Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter, Phase II Study to Evaluate the Impact of MABT5102A on Brain Amyloid Load and Related Biomarkers in Patients With Mild to Moderate Alzheimer's Disease
ctiprofile -
Yang T, Dang Y, Ostaszewski B, Mengel D, Steffen V, Rabe C, et al. Target Engagement in an AD Trial: Crenezumab Lowers Abeta Oligomer Levels in CSF. AAIC-2018 2018; abstr. 27194.
Available from: URL: https://ep70.eventpilotadmin.com/web/planner.php?id=AAIC18 -
New Phase 2 Data Analysis for Crenezumab Presented at Global Alzheimer's Conference Provides Strong Evidence for Engagement of the Principle Abeta Target.
Media Release -
A Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of MABT5102A in Patients With Mild to Moderate Alzheimer's Disease (ABBY)
ctiprofile -
Phase I Clinical Study of Crenezumab in Patients with Alzheimer's Disease
ctiprofile -
A Phase Ib, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-Arm, Multiple-Dose Study to Assess The Safety, Tolerability, And Pharmacokinetics of Intravenous Crenezumab Administered in Patients With Mild to Moderate Alzheimer's Disease
ctiprofile -
AC IMMUNE PARTNER GENENTECH PRESENTS IMPORTANT DATA ON ALZHEIMER'S THERAPY CRENEZUMAB.
Media Release -
A Phase 1, Single-Dose, Randomized, Open-Label, Parallel Group Study to Assess the Relative Bioavailability and Tolerability of Two Formulations of Crenezumab in Healthy Subjects Following Subcutaneous Administration
ctiprofile -
Technology Pioneer 2009 - AC Immune Highlights Significant Clinical Milestones in Alzheimer′s Disease Drug Development.
Media Release -
A Phase I, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Intravenous MABT5102A Administered in a Single-Dose, Dose-Escalation Stage Followed by a Multidose, Parallel-Treatment Stage in Patients With Mild to Moderate Alzheimer's Disease
ctiprofile -
A Phase I, Single-Dose, Randomized, Parallel-Group, Open-Label Study of the Safety, Tolerability, Pharmacokinetics, and Bioavailability of IV and SC MABT5102A in Healthy Volunteers
ctiprofile -
AC Immune SA: New Data Supporting Crenezumab as Potential Alzheimer's Therapy.
Media Release -
Landmark Alzheimer's Prevention Trial Unable to Show Significantly Slower Cognitive Decline in Inherited Form of Disease.
Media Release -
SEC. Internet-Doc 2022;.
Available from: URL: https://www.sec.gov/ix?doc=/Archives/edgar/data/1651625/000114036122010439/brhc10035387_20f.htm#overview -
AC Immune SEC 6th July. Internet-Doc 2021;.
Available from: URL: https://www.sec.gov/Archives/edgar/data/1651625/000095010321004378/dp148007_20f.htm -
Humanized anti-beta-amyloid antibody - US Patent. Internet-Doc 2021;.
Available from: URL: https://patents.google.com/patent/US7892544B2/en -
Crenezumab Phase II cognition data in Alzheimer's disease presented.
Media Release
Adis International Ltd. Part of Springer Science+Business Media
© Springer Nature Switzerland AG