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 peter.loftus@dowjones.com
Subscribe to WSJ: http://online.wsj.com?mod=djnwires