Following years of accusations of scientific malfeasance, Alzheimer’s drug developer Cassava Sciences disclosed Monday that two of its senior employees are being investigated by the US Securities and Exchange Commission and the Department of Justice.
The company’s announcement comes after former science advisor Hoau-Yan Wang was indicted last week by a federal grand jury for allegedly defrauding the US government. In response to findings from those charges and “new information” provided by the SEC, Cassava says its board has begun its own internal probe. Cassava said that it’s cooperating with the DOJ and SEC.
The company has been dogged by allegations of misconduct for years, stemming from reports in 2021 and 2022 that federal agencies were investigating it for manipulating research of its investigational Alzheimer’s medication. Many of those questions have since centered on Wang, including an inspection from the FDA and an investigation from his employer, the City University of New York (CUNY).
In a July 2022 statement, Cassava CEO Remi Barbier said that “allegations of research misconduct are false.”
“No government agency has informed us that it has found supporting evidence of research misconduct or any other wrong-doing, and for good reason — there is no supporting evidence for allegations of research misconduct,” he said at the time.
Wang, a paid science advisor for Cassava conducting research on behalf of the company while at CUNY, allegedly defrauded the National Institutes of Health out of $16 million in grants from 2017 to 2021 using falsified research. Cassava said in a statement Friday that Wang’s work “was related to the early development phases of the company’s drug candidate and diagnostic test and how these were intended to work.”
That research, co-authored with Cassava SVP of neuroscience Lindsay Burns, contributed to the discovery of the company’s lead asset, simufilam. Cassava said that for more than 10 years, Wang was paid $2,000 a month as an advisor. He was also given stock options, all of which were granted between 2015 to 2019.
The company says neither Wang nor CUNY have been involved in the ongoing Phase 3 studies of simufilam. But he did contribute to a prior Phase 2b study, conducting bioanalysis of cerebrospinal fluid biomarker data. Cassava reported that patients given simufilam had statistically significant improvements in the biomarkers compared to placebo.
Cassava also said in its disclosure that “certain statistical information” was emailed to Wang by a senior employee that could’ve unblinded him to some of the participants in the Phase 2b trial. The biotech says that bioanalysis of Phase 3 data will be assessed by an independent third-party consulting firm.