Posted on August 7, 2012 · Posted in Brain Injury

Here’s another discouraging setback in the research for a cure for Alzheimer’s disease.

On Monday Pfizer Inc. and Johnson & Johnson announced that they were shelving late-stage clinical trials of a drug, bapineuzumab, that many had believed would be the first to be approved by federal regulators to slow Alzheimer’s.

“We are obviously very disappointed in the outcomes of this trial,” Dr. Steven Romano, senior vice president, head, Medicines Development Group, Global Primary Care Business Unit, Pfizer, said in a statement. “We are also saddened by the lost opportunity to provide a meaningful advance for patients afflicted with mild-to-moderate Alzheimer’s disease and their caregivers. Yet these data, and the subgroup and biomarker analyses underway, will further inform our understanding of this complex disease and advance research in this field.”

Bapineuzumab was supposed to stop the buildup of plague in the brain that is one of the hallmarks of Alzheimer’s.

On Monday Pfizer said that  the co-primary clinical endpoints, change in cognitive and functional performance compared to placebo, were not met in J&J’s Janssen Alzheimer Immunotherapy R&D LLC -led Phase 3 trial of intravenous bapineuzumab in patients with mild-to-moderate Alzheimer’s disease who do not carry the ApoE4 (apolipoprotein E epsilon 4) genotype, which is a marker for the disease.

Based on the topline results of the study, together with the topline results of a Janssen AI-led Phase 3 study in patients who carry the ApoE4 genotype announced July 23, Janssen and Pfizer decided to discontinue all other bapineuzumab IV studies in patients with mild-to-moderate Alzheimer’s disease.

Two weeks ago Pfizer revealed that in one trial, bapineuzumab hadn’t stymied the mental decline in Alzheimer’s patients who carry the gene.

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.

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.

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.

Bapineuzumab IV, an investigational therapy studied for the treatment of mild-to-moderate Alzheimer’s disease, 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.

About the Author

Attorney Gordon S. Johnson, Jr.
Past Chair Traumatic Brain Injury Litigation Group, American Association of Justice :: 800-992-9447