In September 2022, FDA officials conducted an inspection at a research facility affiliated with the City University of New York (CUNY), uncovering significant deficiencies in the lab of pharmacologist Hoau-Yan Wang. Wang's lab had been involved in analyzing samples for an experimental Alzheimer’s drug, simufilam, developed by Cassava Sciences.
The inspection revealed that Wang had failed to adhere to routine calibration procedures and utilized improper statistical tests, casting doubt on the accuracy of the trial results. Despite these findings, Cassava Sciences had publicly touted the trial as successful, leading to ongoing phase 3 trials of the drug.
The recently disclosed FDA report raises concerns about the credibility of Wang's work and calls into question the integrity of claims surrounding simufilam. Previous investigations into Wang's research practices have also raised suspicions of scientific misconduct.
Cassava Sciences maintains that Wang's lab was not obligated to comply with FDA regulations for Good Laboratory Practices (GLPs) and asserts that subsequent academic research has validated their findings. However, critics argue that the FDA findings undermine confidence in the clinical trials of simufilam.
The report highlights lapses in data management and record-keeping practices, as well as concerns regarding the handling of outlier data. Despite attempts to rectify errors, the FDA inspectors identified additional discrepancies, further eroding confidence in the trial results.
The implications of the FDA inspection on the ongoing phase 3 trials of simufilam remain uncertain. However, experts emphasize that the findings raise serious doubts about the reliability of the data generated from Wang's lab.
In response to inquiries, neither the FDA nor CUNY provided comments regarding the report. Cassava Sciences declined to address specific questions but affirmed that the data corrections made did not materially alter the results.
The revelations from the FDA inspection underscore the need for rigorous oversight in clinical trials and prompt calls for increased scrutiny in Alzheimer’s drug development.
