By Peter Loftus
Bristol-Myers Squibb Co. (BMY) has terminated its development of an experimental Alzheimer's disease treatment, saying the efficacy results of clinical testing so far didn't justify further development.
The company recently assessed results from a midstage, or phase 2, clinical study of avagacestat in mild-to-moderate Alzheimer's patients, as well as an ongoing phase 2 study in predementia patients.
"The evaluation did not establish a profile that supported advancement to Phase 3 development," the New York-based drug maker said in a statement posted on its website Friday.
Bristol said dosing in the ongoing phase 2 study will be discontinued as soon as it's feasible.
The company conducted an interim analysis in November of the study in predementia patients. "No new safety issues emerged in this interim analysis; however, the efficacy observed did not justify further development when evaluated in the context of all avagacestat data," the company said.
Bristol-Myers had previously expressed hope that testing avagacestat in patients with few or no symptoms of Alzheimer's would yield promising results. Standard practice has been to test experimental treatments in mild-to-moderate Alzheimer's.
Avagacestat is the latest experimental Alzheimer's drug to fail in clinical testing. Earlier this year, Johnson & Johnson (JNJ) and Pfizer Inc. (PFE) ended development of an intravenous formulation of bapineuzumab after it failed to show significant benefit in testing.
Current treatments don't stop the progression of the underlying disease, which impairs memory and cognitive skills primarily in the elderly. About 5 million Americans are estimated to have Alzheimer's.
Drug makers are continuing to study potential new treatments, however. On Monday, Merck & Co. (MRK) announced it is starting a new clinical trial of experimental Alzheimer's drug MK-8931.
And Eli Lilly & Co. (LLY) hasn't given up on its experimental Alzheimer's drug solanezumab after reporting mixed efficacy results from clinical testing.
Write to Peter Loftus at [email protected]
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