Bristol-Myers Squibb Company announced the results of a Phase II study evaluating the safety and tolerability of the investigational gamma secretase inhibitor BMS-708163 in patients with mild-to-moderate Alzheimer’s disease.
BMS-708163 is an oral gamma secretase inhibitor designed for selective inhibition of amyloid beta (A?) synthesis. A? is hypothesized to play a central role in the development of Alzheimer’s disease. In healthy people, A? breaks down and is eliminated; but in people with Alzheimer’s disease, A? accumulates and forms “amyloid plaques” in the brain. While the chain of events that lead to the development of Alzheimer’s is still unclear, the accumulation of A? and the resulting formation of amyloid plaques are considered hallmarks of the disease pathology.
The randomized, double-blind, placebo-controlled study (CN156-013) demonstrated that BMS-708163 doses below 100 mg/day provide a potential therapeutic window for further evaluation in Phase III registrational studies.
Of the four BMS-708163 doses evaluated in the study (25 mg, 50 mg, 100 mg and 125 mg/day), doses below 100 mg/day demonstrated acceptable tolerability profiles for further development and were associated with discontinuation rates comparable with placebo. BMS-708163 doses at or above 100 mg were associated with higher discontinuation rates, most commonly due to gastrointestinal and dermatological side effects.
“The safety and tolerability results of this Phase II study in mild-to-moderate Alzheimer’s disease support the further clinical evaluation of Bristol-Myers Squibb’s gamma secretase inhibitor,” says Stephen Salloway, MD, professor of neurology and psychiatry, Brown University, and director, The Butler Hospital Memory and Aging Program.
Release Date: July 20, 2011
Source: Bristol-Myers Squibb Company
Filed Under: Drug Discovery