Cassava Sciences has chalked up one win in an ongoing battle over the integrity of its clinical trials for Alzheimer’s disease. The FDA is declining to intervene in a citizen petition's plea to halt ongoing clinical trials of the company's drug, simufilam, saying the petition was not the appropriate venue for such a complaint.
That still leaves a federal investigation from the U.S. Securities and Exchange Commission and other unnamed government agencies, which are looking into allegations that the biotech manipulated data for the experimental Alzheimer's med called simufilam.
Cassava CEO Remi Barbier called the FDA’s decision “very welcome but not surprising,” in a statement Thursday.
“We said from the outset that the allegations are false. I think the message may be that the FDA’s citizen petition privilege is not to be trifled with by stock market participants,” Barbier said.
The original complaint was filed in August by a lawyer representing short sellers of Cassava’s stock, with supplemental requests added through the year. The group detailed “grave concerns about the quality and integrity of the laboratory-based studies surrounding this drug candidate and supporting the claims for its efficacy.”
Simufilam does not attempt to clear amyloid from the brain like other common Alzheimer’s treatment in development but instead tries to stabilize a scaffolding protein called filamin A. The petition claimed that no lab has confirmed a link between filamin A and Alzheimer’s disease or its effect on models for the disease. The petitioners further alleged data anomalies and manipulation including image alteration in Cassava’s clinical work.
While the FDA said it wouldn't intervene in the petition's request to halt ongoing clinical trials, the agency was clear that it was not ruling on the allegations.
“We take the issues you raise seriously. Please note that your petitions are being denied solely on the grounds that your requests are not the appropriate subject of a citizen petition,” wrote Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research.
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Cassava is enrolling mild to moderate Alzheimer’s in two phase 3 simufilam trials.
As for the government inquiries, Cassava reported in a November 2021 filing to the SEC that the company has received requests from “certain government agencies” for corporate information and documents. The agencies have not informed the company of any wrongdoing, according to the filing.