Cassava has faced scientific scrutiny — and federal charges — over allegations of fraud around simufilam. Now, the company is throwing in the towel on Alzheimer’s treatments altogether.
In November of last year, Cassava Sciences announced their experimental Alzheimer’s drug simufilam failed to slow cognitive or functional decline in its 52-week Phase 3 trial. The trial that failed is over, and the company has also shut down a second ongoing Phase 3 trial because of this negative data. Last week, the company shared data from its halted Phase 3 trial, showing again that the drug had no effect on Alzheimer’s disease.
“We are disappointed that the results of REFOCUS-ALZ and RETHINK-ALZ showed no treatment benefit for patients with mild-to-moderate Alzheimer’s disease,” said Rick Barry, president and CEO of Cassava. “These results were unambiguous.”
The company will phase out its work on Alzheimer’s disease and will pivot to test the drug to treat epilepsy caused by a rare genetic disease called tuberous sclerosis complex.
Cassava Sciences has faced intense scrutiny from researchers and regulators in the last several years, accusing researchers who developed simufilam of committing data manipulation and fraud. Earlier this year, Hoau-Yan Wang, the drug’s co-developer and former paid advisor who was indicted by the Department of Justice for fraud and was also charged by the Securities and Exchange Commission with manipulating clinical trial results.
Meanwhile, the former CEO Remi Barbier and vice president of neurosciences Lindsay Burns settled with the SEC for making misleading statements about the drug, before stepping down from the company.
Some experts have criticized regulators for allowing Cassava’s drug to continue through Phase 3 clinical trials, questioning the ethics of continuing to run the study despite the serious allegations of fraud.
No participants in clinical trials are any longer taking simufilam. Cassava Sciences said they will present the negative trial data and make it available to other researchers.