The credibility of the clinical trial results for an experimental Alzheimer’s drug has been called into question following a critical inspection report by the Food and Drug Administration (FDA).

What Happened: The FDA report, which was released under the Freedom of Information Act, highlighted several issues with the clinical trial work conducted by pharmacologist Hoau-Yan Wang at the City University of New York (CUNY), reported Science.org.

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 (NASDAQ:SAVA).

Cassava Sciences Inc, Hoau-Yan Wang And FDA did not immediately respond to Benzinga's request for comment. (edited)

The 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.

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Despite the FDA’s findings, Cassava 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 expresses his concerns, stating, that this report adds to a series of data that lack rigor and reliability, further eroding my trust in any clinical trial outcomes from this initiative.

Schrag, a professor at Vanderbilt University, who previously flagged what he considered problematic data from the company and Wang, independently reviewed the FDA report for Science. "As I've said before, I think that the simufilam clinical trials should be shut down," he said.

Why It Matters: 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. The drug was intended for the treatment of Alzheimer’s disease dementia.

However, the recent FDA report raises questions about the accuracy of these findings, adding to the scrutiny the drug has faced. This scrutiny includes a new era in Alzheimer’s diagnosis and the ongoing development of vaccines targeting the removal of toxic proteins from the brain.

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.

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