In yet another research disappointment, US drug major Bristol-Myers Squibb (NYSE: BMY) recently assessed data on avagacestat from a completed Phase II study in mild-to-moderate Alzheimer's disease and an ongoing Phase II study in pre-dementia Alzheimer’s disease.
The evaluation did not establish a profile that supported advancement to Phase III development. In light of this finding, B-MS has decided to terminate the avagacestat clinical development program. Dosing in the ongoing Phase II study in pre-dementia Alzheimer’s disease (CN156-018) will be discontinued as soon as operationally feasible.
Avagacestat is the latest experimental Alzheimer's drug to fail in clinical testing. Earlier, Johnson & Johnson (NYSE: JNJ) and Pfizer (NYSE: PFE) ended development of an intravenous formulation of bapineuzumab after it failed to show significant benefit in Phase III trials (The Pharma Letter August 7). The co-primary clinical endpoints, change in cognitive and functional performance compared to placebo, were not met in the studies. Also, Eli Lilly’s solanezumab showed mixed results in two recent Phase III studies (TPL October 9). On a positive note for the Alzheimer’s community, Merck & Co yesterday said it was progressing its AD candidate MK-8931 into Phase II/III (see separate story today).
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