Eli Lilly and Company presented data from the first of two Phase III trials of semagacestat, including data from a 32 week follow-up period after dosing was halted in August 2010.
Semagacestat is a gamma secretase inhibitor that had been studied as a potential treatment for Alzheimer’s disease. The results shown provide patient outcomes from the active treatment portion of the study and from a modified portion of the study conducted after dosing with semagacestat was stopped.
The study data confirmed preliminary results that showed that during the period of dosing, patients receiving semagacestat declined at a greater rate than patients taking placebo. During the follow-up period after dosing was halted, the cognitive and functional deficits of the patients initially treated with semagacestat remained worse than the deficits of patients initially treated with placebo. However, the course of the decline over time in the two groups did not diverge further after dosing was stopped.
The dosing in both semagacestat trials was halted in August 2010 because preliminary results from the two Phase III trials showed semagacestat did not slow Alzheimer’s disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living. Lilly continued to gather data, including cognitive scores, for 32 weeks after dosing was stopped.
“When we made the decision to halt dosing in the trials, we committed to collecting this data in an effort to benefit future Alzheimer’s research and to provide safety follow-up for the patients,” says Eric Siemers, MD, senior medical director for the Alzheimer’s team at Lilly.
Release Date: July 19, 2011
Source: Eli Lilly and Company
Filed Under: Drug Discovery