The credibility of clinical trial results for an experimental Alzheimer’s drug has come under scrutiny following a critical inspection report by the Food and Drug Administration (FDA). The report highlighted several issues with the work conducted by pharmacologist Hoau-Yan Wang at the City University of New York (CUNY).
Wang’s lab had analyzed samples of patients’ blood and cerebrospinal fluid from a key trial of the drug, simufilam, developed by his longtime collaborator, Cassava Sciences Inc. The FDA inspectors found that Wang had not performed routine calibration of his equipment, used improper statistical tests, and failed to complete verification experiments. These issues led to an inaccurate determination of sample concentrations, raising concerns about the reliability of the trial results.
Despite the FDA’s findings, Cassava Sciences publicly reported the trial’s findings as positive and used them to proceed with phase 3 trials of the drug, which are currently ongoing. Critics of Cassava argue that the FDA findings amplify worries regarding the lack of robust support for human trials of simufilam. Neuroscientist Matthew Schrag expressed his concerns, stating that this report adds to a series of data that lack rigor and reliability, further eroding trust in any clinical trial outcomes from this initiative.
This report is the latest in a series of setbacks for the Alzheimer’s drug. In February, Cassava Sciences’ stock soared after the company reported positive results from a two-year clinical safety study of simufilam. However, the recent FDA report raises questions about the accuracy of these findings, adding to the scrutiny the drug has faced.
Despite the setbacks, Cassava Sciences has continued with its phase 3 trials. The FDA’s decision on these trials will be crucial for the future of simufilam and the company. The scrutiny surrounding this drug highlights the challenges and complexities of developing treatments for Alzheimer’s disease.
In conclusion, the FDA inspection report has raised significant concerns about the reliability of the clinical trial results for the experimental Alzheimer’s drug, simufilam. The ongoing phase 3 trials will be closely watched to determine the future of the drug and the company behind it. As the field of biotech and genetic research continues to evolve, ensuring the integrity and accuracy of clinical trial data is essential for the development of effective treatments for complex diseases like Alzheimer’s.
