Pfizer Inc. and Johnson & Johnson had bad news to report last week on one of four clinical trials of their Alzheimer’s disease drug bapineuzumab.
In a press release Pfizer announced that the drug didn’t improve cognition or function in patients with mild-to-moderate Alzheimer’s disease who carry the ApoE4 (apolipoprotein E epsilon 4) genotype in one of its trials. That gene variation is considered a major risk factor for Alzheimer’s.
Pfizer and Johnson & Johnson, via its Janssen AI unit, are partners in the Alzheimer’s Immunotherapy Program (AIP).
“These clinical findings have been shared with regulatory authorities and study investigators so that participants in the ongoing clinical program can be informed,” Pfizer said. “Because in this study clinical efficacy was not demonstrated in ApoE4 carriers, the Janssen AI and Pfizer Joint Steering Committee for the AIP has decided that participants from this study who enrolled in a follow-on extension study will no longer receive doses of bapineuzumab. However, these patients will have a follow-up evaluation.”
But the show will go on.
“Based on a comprehensive review of the data by the independent safety monitoring committee, all other ongoing Janssen AI and Pfizer bapineuzumab studies are continuing as planned and without modifications,” Pfizer said.
Pfizer and Johnson & Johnson have high hopes for another North American late-stage trial of bapineuzumab, of patients with mild-to-moderate Alzheimer’s disease who do not carry the ApoE4 genotype, are expected to be announced later this summer. All in all, there are three trials ongoing.
“While we are disappointed in the topline results of Study 302, a more complete understanding of bapineuzumab and its potential utility in mild-to-moderate Alzheimer’s disease will be gained following the availability of additional data, including data from the soon-to-be available non-carrier Study 301,” said Dr. Steven Romano, senior vice president and head, Pfizer’s Medicines Development Group, Global Primary Care Business Unit.
“We recognize that Alzheimer’s disease is very complex, but Pfizer, along with our partner Janssen AI, remains committed to advancing the science of Alzheimer’s disease, with the ultimate goal of delivering innovative and meaningful new treatment options to patients,” he said in a statement.
According to Pfizer, “The presence of the ApoE epsilon 4 genotype is a genetic risk factor for Alzheimer’s disease and is associated with increased beta-amyloid plaques in the brains of patients with the disease.
Bapineuzumab IV, is an investigational therapy being studied for the treatment of mild-to-moderate Alzheimer’s disease. It is is an antibody that targets beta-amyloid (Aβ), 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.