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.
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.
Cassava said in a statement at the time that “Dr. Wang and his former public university medical school have had no involvement in the Company’s Phase 3 clinical trials of simufilam.”
Then, in September, Cassava and two of its former executives agreed to pay $40 million in a settlement with the SEC after the agency accused Cassava of “misleading statements made in September 2020 about the results of a Phase 2 clinical trial for the company’s purported therapeutic for the treatment of Alzheimer’s disease.” That same SEC order also charged Wang for “manipulating the reported clinical trial results.”
Vanderbilt University neuroscientist Matthew Schrag has previously blown the whistle on potentially objectionable data and images from both Wang and Cassava.
In an interview with Science this September, Schrag said, “There is strong evidence of corruption of the basic science and pharmacology data on which the Phase 2 trials were based. Now, there is strong evidence of corruption of the Phase 2 trial data on which the Phase 3 trials are based.”