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Crenezumab - AC Immune/Genentech/Universidad-de-Antioquia

Drug Profile

Crenezumab - AC Immune/Genentech/Universidad-de-Antioquia

Alternative Names: Anti-Abeta antibody; MABT5102A; R 5490245; RG 7412; RO 5490245

Latest Information Update: 29 Aug 2019

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

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Alzheimer's disease

Most Recent Events

  • 09 Aug 2019 Roche completes 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, Ukraine, United Kingdom and USA (NCT03491150) (EudraCT2017-002702-12)
  • 30 Jun 2019 Genentech initiates a phase II trial for Alzheimer's disease in USA (IV) (SC) (NCT03977584)
  • 06 Jun 2019 Genentech plans a phase II trial for Alzheimer's disease in June 2019 (NCT03977584)

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 phase III development in the US, the EU and several other countries. 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.

Company Agreements

In December 2006, AC Immune entered into an exclusive, worldwide licensing agreement with Genentech for the development of anti-beta-amyloid antibodies for the treatment of AD. Under the terms of the agreement, Genentech will gain full ownership of crenezumab and will be responsible for global development, manufacturing and commercialisation of the antibody. AC Immune received an upfront payment and clinical and regulatory milestone payments totalling over $US300 million, following initiation of phase I, II and III studies. Upon commercialisation, Genentech will pay AC Immune royalties on any product sales resulting from the collaboration [1] [2] .

Key Development Milestones

According to Roche's pipeline as at October 2014, regulatory filings for crenezumab in treatment of Alzheimer's disease are expected post 2017.

In May 2019, Roche completed the phase III CREAD OLE trial, long-term extension of phase III studies (BN29552/BN29553) [see below], which evaluated the safety and efficacy patients on of long-term crenezumab IV infusion in patients with Alzheimer's disease (BN40031; EudraCT2017-002702-12; NCT03491150). The open-label study that was initiated in April 2018 enrolled 149 patients in Australia, Canada, Finland, France, Germany, Hong Kong, Italy, South Korea, Lithuania, Mexico, Poland, Russia, Spain, Turkey, Ukraine, the UK and the US [3] .

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. [4] [5] [6] [7] [8] [9] .

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 [4] [5] [10] .

In June 2019, Genentech initiated a phase II trial to evaluate 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 will receive up to three intravenous (IV) injections of [^18F] Genentech Tau Probe 1 (GTP1) and will undergo a tau positron emission tomography (PET) scan after each IV injection of [18^F]GTP1. The purpose of this substudy is to increase the understanding of disease progression in the preclinical stage of familial Alzheimer's Disease (AD). The double-blind, randomised trial is enrolling approximately 150 patients in the US [11] [12] .

In November 2013, Genentech initiated a phase II clinical trial to investigate 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). Shortly afterward, in December 2013, the first drug doses were administered to study participants. The double-blind trial is recruiting approximately 300 participants, aged 30-60 years, from a large extended family in Colombia who have a genetic mutation that typically leads to the early onset of Alzheimer's disease symptoms. A small number of patients from the US will also be recruited. Participants will receive crenezumab injections SC at two-weekly intervals for up to five years. The trial will also include relatives who are non-carriers of the mutation; these individuals will receive placebo. The effects of crenezumab on the accumulation of amyloid and other key proteins are being evaluated using imaging techniques, cerebrospinal fluid tests and cognitive measures, including cognitive function. 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. 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 [13] [14] . PRA, a clinical research organisation, announced its participation in this trial in July 2012 [15] . The trial is expected to end in 2020; study results will be released soon after [16] .

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 [17] .

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) [18] [19] . The pooled analysis results from the ABBY and BLAZE phase II trials were presented at the Alzheimer's Association International Conference (AAIC-2018) [20] [21] .

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) [18] [22] .

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 [23] .

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 [24] . 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 [25] .

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 [26] .

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 [27] [28] .

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 [29] .

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 [30] .

Patent Information

Crenezumab is protected under US Patent US7892544, which was filed June 12, 2007.

Drug Properties & Chemical Synopsis

  • Route of administration IV, SC
  • Formulation Infusion, Injection
  • Class Antibodies, Antidementias, Monoclonal antibodies
  • Target Amyloid beta protein; 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

not specified

Tau protein

PSEN1

1

1

Alzheimer's disease

Inclusion

Amyloid beta

1

Alzheimer's disease

Outcome Measure

Tau protein

single-strand-selective monofunctional uracil-DNA glycosylase 1

sarcoglycan, alpha (50kDa dystrophin-associated glycoprotein)

Amyloid beta

2

1

1

2

Biomarker

Drug Name Biomarker Name Biomarker Function
Crenezumab - AC Immune/Genentech/Universidad-de-Antioquia Amyloid beta Inclusion, Outcome Measure
PSEN1 not specified
sarcoglycan, alpha (50kDa dystrophin-associated glycoprotein) Outcome Measure
Tau protein Outcome Measure
For more detail, check out BiomarkerBase: the leading source of information about biomarkers used in drug development and diagnostic tests, tracking a comprehensive list of biomarker uses worldwide by over 800 companies

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
Alzheimer's disease - - Phase III Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, England, Estonia, Finland, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Russia, Scotland, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey, USA, Ukraine, United Kingdom IV / Infusion Genentech 21 Mar 2017
Alzheimer's disease - - Phase III Switzerland IV / Infusion AC Immune, Genentech 22 Mar 2016
Alzheimer's disease - - Phase II Canada, France, Germany, Spain, USA, United Kingdom SC / Injection Genentech 09 Apr 2012
Alzheimer's disease - Prevention Phase II Colombia SC / Injection Genentech, Universidad de Antioquia 30 Nov 2013

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 World
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, Roche III 2022 20 - - 22 Oct 2018

Credit Suisse Financial Forecast

Indication Region 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 Last Update
Alzheimer's Wrld (50% US) 0 0 0 0 0 0 250 750 1875 2344 22 Oct 2018
Total 0 0 0 0 0 0 250 750 1875 2344

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 [25] [24] .

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 [18] .

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 [25] [24] .

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 [30] .

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 [31] [18] [22] .

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 [18] [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 [20] [21] [19] [22] .

Future Events

Expected Date Event Type Description Updated
31 Dec 2017 Trial Update Genentech plans a phase III CREAD2 trial for Alzheimer's disease [7] 13 Apr 2017

Development History

Event Date Update Type Comment
09 Aug 2019 Trial Update Roche completes 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, Ukraine, United Kingdom and USA (NCT03491150) (EudraCT2017-002702-12) Updated 09 Aug 2019
30 Jun 2019 Trial Update Genentech initiates a phase II trial for Alzheimer's disease in USA (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 [4] Updated 01 Feb 2019
29 Oct 2018 Scientific Update Pharmacodynamics data from an in vitro study in Alzheimer's disease released by AC Immune [30] Updated 02 Nov 2018
22 Oct 2018 Financial Update Credit Suisse financial data update Updated 04 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 [21] 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) [20] 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
24 Jun 2018 Biomarker Update Biomarkers information updated Updated 31 Aug 2018
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 [7] 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 [25] 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 [8] 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) [18] 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 (prevention) in Colombia (SC) 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 [13] 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 [13] 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

References

  1. AC Immune Therapy chosen for groundbreaking Alzheimer's Disease Trial in Colombia and USA.

    Media Release
  2. Genentech and AC Immune: Exclusive License Agreement.

    Media Release
  3. A Multicenter, Open-Label, Long-Term Extension Of Phase III Studies (BN29552/BN29553) Of Crenezumab In Patients With Alzheimer's Disease

    ctiprofile
  4. 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
  5. 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
  6. AC IMMUNE REPORTS FULL YEAR 2016 FINANCIAL RESULTS AND R&D UPDATE.

    Media Release
  7. AC IMMUNE PARTNER GENENTECH TO START SECOND PHASE 3 CLINICAL TRIAL FOR ALZHEIMER'S THERAPY CRENEZUMAB.

    Media Release
  8. Roche delivers strong performance in the first half of 2015.

    Media Release
  9. 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
  10. 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
  11. AC Immune Reports Q2 2019 Financial Results, Business and Clinical Update.

    Media Release
  12. 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
  13. Groundbreaking Alzheimer′s Disease Prevention Trial Announced.

    Media Release
  14. 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
  15. PRA Participates in Landmark Alzheimer's Prevention Clinical Trial.

    Media Release
  16. ALZHEIMER'S PREVENTION INITIATIVE TRIAL MARKS MILESTONE.

    Media Release
  17. 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
  18. Roche announces phase II clinical results of crenezumab in Alzheimer's disease.

    Media Release
  19. 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
  20. 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
  21. 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
  22. 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
  23. Phase I Clinical Study of Crenezumab in Patients with Alzheimer's Disease

    ctiprofile
  24. 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
  25. AC IMMUNE PARTNER GENENTECH PRESENTS IMPORTANT DATA ON ALZHEIMER'S THERAPY CRENEZUMAB.

    Media Release
  26. 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
  27. Technology Pioneer 2009 - AC Immune Highlights Significant Clinical Milestones in Alzheimer′s Disease Drug Development.

    Media Release
  28. 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
  29. 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
  30. AC Immune SA: New Data Supporting Crenezumab as Potential Alzheimer's Therapy.

    Media Release
  31. Crenezumab Phase II cognition data in Alzheimer's disease presented.

    Media Release
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