In This Article:
In March, pharmaceutical company Cassava Sciences made headlines for a report by the Food and Drug Administration (FDA) that cast doubt on the positive trial results of its novel Alzheimer’s drug, simufilam.
Most Read from Fast Company
-
Housing market shift: Where home prices are actually falling
-
18-year-old Butterball turkey video haunts company at its busiest time of the year
Then, in September, the Securities and Exchange Commission (SEC) settled with Cassava over charges that the company had misled investors about the effectiveness of its new drug.
And today, Cassava announced that its Phase 3 trials of simufilam failed to meet all of its main goals.
This latest disappointing news came in the form of a company press release, which noted that “the topline results from the Phase 3 ReThink-ALZ study of simufilam in mild-to-moderate AD did not meet each of the pre-specified co-primary, secondary and exploratory biomarker endpoints.”
The release went on to note that in the wake of these results, Cassava decided to discontinue a planned second Phase 3 trial of the drug.
Cassava Sciences’ stock (NASDAQ: SAVA) plummeted on Monday by a staggering 85%.
“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,” Cassava president and CEO Rick Barry said in a statement. “We took careful measures to enroll patients with mild-to-moderate AD. Despite that, the loss of cognition in the placebo group was less pronounced than was previously reported in other placebo-controlled studies in AD. We are working to understand this better.”
A litany of troubles and allegations
The study’s failure comes after multiple federal agencies called Cassava’s methods into question. Earlier this year, Science reported that an FDA inspection found that City University of New York (CUNY) researcher Hoau-Yan Wang, who was involved in Cassava’s clinical tests on simufilam, had used questionable data collection practices.
Then, in June, Wang was indicted by the Department of Justice (DOJ) for allegedly “defrauding the National Institutes of Health (NIH) of approximately $16 million.” The DOJ’s release claimed that Wang had participated in “a scheme to fabricate and falsify scientific data in grant applications made to the NIH on behalf of himself and [Cassava Sciences].”
Wang does not appear to have commented on the indictment. We reached out to his attorney for comment.