Danger Dust

The troubled biopharma company Cassava Sciences agreed last week to pay $40 million to settle U.S. Securities and Exchange Commission (SEC) charges that it had misled investors about early clinical results for its experimental Alzheimer’s disease drug, simufilam. The compound is now in pivotal phase 3 trials, but SEC’s announcement may fuel calls to halt those studies.

SEC’s moves follow Wang’s recent indictment by the U.S. Department of Justice for alleged research fraud in laboratory work associated with simufilam, which Wang and Burns invented. The Food and Drug Administration (FDA) had identified a raft of serious deficiencies in Wang’s lab procedures, strongly suggesting some tests he ran on simufilam clinical trial samples were invalid. CUNY itself found Wang had committed “egregious” scientific misconduct associated with his work for Cassava and other studies.

The SEC complaint said Cassava and Barbier knew Wang’s lab was not qualified to conduct the biomarker testing that suggested simufilam was effective for Alzheimer’s, among other problems. The agency also charged that Wang had been “unblinded” for patient fluid samples that he tested. That means he would have known which samples came from those given the drug rather than a placebo, potentially biasing his data.