As preliminary results of Phase III clinical trials showed no benefits regarding Alzheimer’s disease progression, and some worsening of symptoms, Eli Lilly & Co. (Lilly) announced that it has stopped the development of semagacestat, a gamma secretase inhibitor, its Alzheimer’s disease medication.
Eli Lilly said that two ongoing long-term Phase III studies:
..showed it did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living.
In a press release Lilly said its decision to halt development does not affect the ongoing clinical trials of solanezumab, another compound which is also in Phase III trials as a possible Alzheimer’s treatment. While both solanezumab and semagacestat focus on amyloid-beta proteins, which are thought to play a critical role in Alzheimer’s disease, they have different mechanisms of action.
Semagacestat was compared with a placebo (dummy drug) in over 2,600 patients with mild-to-moderate Alzheimer’s disease.
An interim analysis reveal that, as expected, cognition and the ability to complete activities of daily living worsened for those on the placebo. However, those on semagacestat “worsened to a statistically significantly 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,”, according to Lilly.
Jan M. Lundberg, Ph.D., Executive Vice President, Science and Technology, and President, Lilly Research Laboratories, said:
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. This is a setback, but Lilly’s commitment to beating Alzheimer’s will not waver.
Lilly has told all clinical trial investigators for all semagacestat studies to tell their study participants to stop taking the medication immediately. Participants or their caregivers (UK: carers) should call their study physician and make an appointment. The company says it has informed relevant regulatory agencies and is sending instructions to investigators on the process for finalizing the studies.
Lilly says that its decision to halt development will probably result in a third-quarter charge to earnings of approximately $.03 to $.04 per share.
John C. Lechleiter Ph.D., Lilly’s chairman and chief executive officer, said:
We are clearly disappointed by the results we are announcing today. However, Lilly’s innovation strategy, based on advancing a pipeline of nearly 70 molecules currently in clinical development, does not rest on the success or failure of any single compound. Pharmaceutical research always carries risk, as these results show. But it offers as well the potential for tremendous reward for millions of patients who await new medicines. Despite this and other recent setbacks, Eli Lilly and Company remains financially strong and is even more determined to prevail in our quest to provide new treatments for Alzheimer’s and other serious diseases.
Source: Elli Lilly
Written by Christian Nordqvist