The US Securities and Exchange Commission (SEC) has announced that US-based biotech firm Cassava Sciences Inc., along with its founder and former CEO Remi Barbier, and a former vice-president of neuroscience, have consented to pay in excess of USD 40 million to settle allegations of misleading statements concerning the efficacy of their lead Alzheimer’s disease pipeline candidate, simufilam. The settlement, as per Cassava’s statement, does not constitute an admission or denial of the charges but signifies the company’s comprehensive cooperation with the SEC’s inquiry.
The SEC’s investigation focused on statements issued in September 2020 regarding the outcomes of a Phase II clinical trial for simufilam. It was alleged that data from this trial had been manipulated by a Cassava consultant, Dr. Hoau-Yan Wang, a medical professor at the City University of New York. Wang is said to have received unblinded information during the analysis phase, which he used to overstate the effects of simufilam on total tau and phosphorylated tau levels. The company subsequently published these analyses.
Cassava has indicated that simufilam is still under evaluation in a Phase III clinical trial and maintains optimism about potentially delivering a novel treatment option for Alzheimer’s disease patients in the future.- Flcube.com
