The drama surrounding an Alzheimer’s treatment being developed by Cassava Sciences deepened this week with a report that the company is being investigated by the Securities and Exchange Commission.
According to the Wall Street Journal, the SEC has opened an investigation into claims that the company manipulated trial data for its Alzheimer’s candidate, simufilam. 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.
Claims that the company presented misleading data for the drug surfaced in 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 company quickly fired back, calling the allegations “false and misleading.”
Along with the whistleblower submission, two doctors also filed a public petition in August to end clinical trials of the drug, saying that they don’t buy Cassava’s data and that they have shorted the stock, believing that it will plummet once investors learn that they’ve been duped.
Now, the SEC along with the National Institutes of Health — who awarded Cassava $20 million in grants to study the drug — are digging into the claims. Part of the controversy is centered around debate about whether or not the company manipulated images of western blots, which are frequently used by labs to display proteins in samples of tissue or blood.
In a recent securities filing, Cassava said that it is under investigation but did not name a specific government agency. The company’s CEO denied the allegations, calling them “outlandish.”
