Pfizer/Janssen Alzheimer’s drug dropped after failure
pharmafile | August 7, 2012 | News story | Research and Development, Sales and Marketing | Alzheimer's, Janssen, Pfizer, bapineuzumab
Pfizer and Janssen have decided to drop their investigational Alzheimer’s drug bapineuzumab after it failed a second late-stage study.
The two firms said that bapineuzumab IV failed to significantly change cognitive and functional performance in patients with mild-to-moderate Alzheimer’s disease when compared to placebo.
The Phase III study was specifically looking at Alzheimer’s patients who do not carry the ApoE4 genotype.
Just two weeks ago both firms announced the failure of another study for the drug, which was being tested in patients who do carry the ApoE4 gene, and makes them more likely to get the disease.
There too the study found that the drug was no better than placebo.
Bapineuzumab is an injectable monoclonal antibody that works by attacking the beta-amyloid protein, which is believed to play a key role in Alzheimer’s disease.
The drug was in a race with Lilly’s solanezumab, a similar treatment in Phase III, which now looks more likely to become the first therapy to target the cause of Alzheimer’s, rather than just its symptoms.
Janssen told Bloomberg that although they will be ending the IV studies of the drug, a trial for subcutaneous use would continue.
Janssen had been confident that this new trial would be successful, saying last month that a Phase II trial suggested that ApoE4 non-carriers may have a better chance of benefiting from bapineuzumab than ApoE4 carriers – but this has not been the case.
Steven Romano, senior VP and head of the medicines development group at Pfizer, said: “We are obviously very disappointed in the outcomes of this trial. 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.”
Pfizer and its partners may eventually test this version of bapineuzumab in pre-Alzheimer’s patients, if the results of the second stage trial are favourable, according to a research note from Tim Anderson, a Sanford C. Bernstein & Co. analyst in New York.
Ben Adams
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