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 after lead researcher Hoau-Yan Wang, PhD, for the drug candidate was indicted June 27, in a case alleging he fabricated data. The trial has also garnered scrutiny from the Securities and Exchange Commission and the Department of Justice.
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