Date: 2012-08-06
Type of
information: Halting of the trial
phase: 3
Announcement: halting of of the trial
Company: Pfizer (USA - NY) Janssen AI (USA) Elan (Ireland)
Product: bapineuzumab
Action
mechanism: monoclonal antibody. Bapineuzumab is an antibody that targets beta-amyloid, a protein that can exert toxic effects in the brain and is believed to play a central role in the pathology of Alzheimer’s disease.
Disease: Alzheimer's disease
Therapeutic
area: Neurodegenerative diseases
Country:
Trial
details:
- The Alzheimer's Immunotherapy Program (AIP) of Janssen Alzheimer Immunotherapy and Pfizer is an equal collaboration committed to researching and developing selective products for the treatment and/or prevention of neurodegenerative conditions, including Alzheimer’s disease.
- Four placebo-controlled Phase 3 studies comprised the bapineuzumab IV clinical development program.
- Janssen AI led the two completed 18-month, Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety studies of patients who are ApoE4 carriers (Study 302) and ApoE4 non-carriers (Study 301). The two co-primary clinical endpoints were change in the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog), a validated measure of cognition, and the Disability Assessment for Dementia (DAD), a validated instrument to measure function.
- Study 302 included approximately 1,100 patients who carry the ApoE4 genotype. Additionally, Study 301 reported here included approximately 1,300 patients who do not carry the ApoE4 genotype.
- In addition to the Janssen AI-led studies, Pfizer led two primarily ex-North American 18-month, Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety studies of patients with mild-to-moderate Alzheimer’s disease who are ApoE4 non-carriers (Study 3000) and carriers (Study 3001).
Latest
news:
- Johnson & Johnson (J&J) and Pfizer have announced that phase 3 clinical development of bapineuzumab intravenous (IV) in mild-to-moderate Alzheimer’s disease is being discontinued. Based on the topline results of this study, together with the topline results of a Janssen AI-led Phase 3 study in patients who carry the ApoE4 genotype (Study 302) announced on July 23rd, the Janssen AI and Pfizer Joint Steering Committee for the AIP has decided to discontinue all other bapineuzumab IV studies in patients with mild-to-moderate Alzheimer’s disease. This includes not only the Pfizer-led, Phase 3 studies (Study 3000 and Study 3001), but also all follow-on extension studies in patients with mild-to-moderate Alzheimer’s disease receiving bapineuzumab IV. All patients in the discontinued studies will have a follow-up evaluation and the Alliance will conduct final data analyses.
These clinical findings and the decision to discontinue the bapineuzumab IV program in patients with mild-to-moderate Alzheimer’s disease have been shared with regulatory authorities and study investigators.
No new safety concerns were identified in Study 301. The most commonly observed serious adverse events which occurred in bapineuzumab-treated patients more commonly than in placebo-treated patients, and with an incidence of at least 1 percent in the combined 0.5 mg/kg and 1.0 mg/kg group, were pneumonia, ARIA-E (amyloid-related imaging abnormalities-edema or effusion), syncope, hip fracture and convulsion.
- Data from both Study 302 and Study 301 have been accepted as a late-breaker and will be presented in September at the European Federation of Neurological Societies (EFNS) meeting in Stockholm.
Specific details surrounding the anticipated reduction of Janssen AI’s future funding requirements will be determined after discussions with our equity co-investor, Johnson & Johnson and after the complete data set from Study 301 and 302 has been presented at the 16th Congress of the European Federation of Neurological Societies (EFNS) on September 11, 2012, the American Neurological Association (ANA) Annual Meeting on October 8, 2012 and the 5th Clinical Trials on Alzheimer’s Disease (CTAD) on October 29, 2012.
Is
general: Yes
