Cassava Sciences announced that the phase 3 trial of its Alzheimer's drug, simufilam, did not meet its primary endpoints.
The trial, which involved patients with mild-to-moderate Alzheimer's disease, failed to show significant improvement in cognition and daily functioning compared to a placebo after 52 weeks, according to a Nov. 25 news release from the company.
Despite the disappointing results, the drug demonstrated an overall favorable safety profile. As a result, Cassava has decided to discontinue its second phase 3 trial and halt the open-label extension study.
CEO Rick Barry acknowledged the setback, noting that the study's outcome has implications for the company's ongoing research and said Cassava will continue to analyze the data and plans to present detailed results at a future medical meeting.
Simufilam's development history has been dogged by controversy and has garnered scrutiny from the Securities and Exchange Commission and the Department of Justice.