The U.S. Justice Department has opened a criminal investigation into Cassava Sciences probing whether the company manipulated research data for its experimental Alzheimer's drug, according to a Reuters report.
According to two sources familiar with the matter, who spoke on condition of anonymity with Reuters, the DOJ is investigating whether the company or individuals misled or defrauded investors, government agencies or patients.
Claims that Texas-based Cassava presented misleading data for its Alzheimer’s candidate, simufilam, surfaced last August through an FDA whistleblower submission letter with “extensive details” surrounding the “accuracy and integrity of clinical and preclinical data supporting the ongoing clinical evaluation” of the drug. The small molecule drug was developed to restore the normal shape and function of altered filamin A, a scaffolding protein, that is believed to become misshapen in the brains of Alzheimer’s patients.
Following the letter, the company quickly fired back, calling the allegations “false and misleading.”
Then, last Nov., the Wall Street Journal reported that Cassava was being investigated by the Securities and Exchange Commission.
Cassava has maintained its innocence throughout the saga, and it seems will continue to do so. A lawyer representing the company would not confirm nor deny the newest DOJ probe to Reuters, but did make it clear that Cassava Sciences denies all allegations of wrongdoing.
