The Department of Justice and Securities and Exchange Commission are investigating two senior employees of Cassava Sciences in connection with allegations of data manipulation for its Alzheimer’s disease candidate simufilam.
Cassava Sciences disclosed on Monday that two of its senior employees are under investigation by federal agencies in connection with alleged scientific misconduct in its Alzheimer’s disease studies.
The Department of Justice (DOJ) and the Securities and Exchange Commission (SEC) are both investigating the two senior employees, according to Cassava. As part of the federal probes, Cassava’s board of directors has created an ad hoc committee of independent directors to conduct its own internal investigation.
“Cassava is cooperating with the DOJ and SEC in connection with these investigations,” the company said in a statement.
Monday’s announcement comes after a federal grand jury in the District Court of Maryland last week indicted Hoau-Yan Wang, who previously acted as a scientific collaborator and advisor at Cassava. Wang allegedly “caused Cassava to submit grant applications … that contained false and fraudulent representations about his research,” according to the company’s SEC filing.
The indictment against Wang alleged that he made “materially false, fraudulent and misleading” claims regarding the mechanism of action of simufilam, Cassava’s Alzheimer’s disease candidate. According to the indictment, he also allegedly “manipulated or otherwise fabricated research results” including Western Blot data.
Wang worked with Cassava for more than a decade, during which time he was paid a “cash stipend” of $2,000 per month, according to the company’s SEC filing.
Simufilam is an investigational small molecule drug that works by binding to altered filamin A, which is involved in the neurodegeneration process typically seen in Alzheimer’s disease. Cassava is currently running two Phase III trials for simufilam in mild-to-moderate Alzheimer’s disease.
In late 2021, Cassava and simufilam became embroiled in controversy after a whistleblower alleged that that biotech had doctored some of its data. Questions about Cassava’s data manipulation continued over the following months, eventually involving both the SEC and DOJ. In June 2022, the controversy forced journal publisher Springer to pull a paper co-authored by Wang.
Cassava has always maintained that it did not engage in questionable scientific practices. In August 2022, the Journal of Prevention of Alzheimer’s Disease took Cassava’s side, saying that it had found no evidence to support the allegations of data manipulation by the company. Cassava in November 2022 claimed the controversy was started by short-sellers to manipulate the company’s stock price.
Since then, the biotech has doubled down on its defense of simufilam and insisting that it is “confident in the underlying science” of the candidate.
