Eli Lilly and Co. will stop development of semagacestat, a gamma secretase inhibitor in Phase III development as a potential treatment for Alzheimer's disease. Two ongoing Phase III studies showed the drug did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform daily activities.
In the two Phase III trials, semagacestat was compared with placebo in more than 2,600 patients with mild-to-moderate Alzheimer's disease. This interim analysis showed that cognition and the ability to complete activities of daily living of placebo-treated patients worsened, as expected. However, patients treated with semagacestat worsened to a greater degree than those treated with placebo. In addition, data showed semagacestat is associated with an increased risk of skin cancer compared with those who received placebo.
"This is disappointing news for the millions of Alzheimer's patients and their families worldwide who anxiously await a successful treatment for this devastating illness," said Jan M. Lundberg, Ph.D., executive vice president, Science and Technology, and President, Lilly Research Laboratories. "This is a setback, but Lilly's commitment to beating Alzheimer's will not waver.”