Cassava Sciences drug company executives and researchers have faced scrutiny from researchers and federal regulators over their drug simufilam. Today, the company announced the drug had failed its first Phase 3 trial and shut down its only other ongoing trial.
On November 25th, 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.
“The results are disappointing for patients and their families who are living with this disease and physicians who have been looking for novel treatment options,” said Rick Barry, president and CEO of Cassava. “We have a special gratitude for the patients and their families and caregivers who participated in our clinical program for Alzheimer’s Disease.”
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.