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FDA Denies Petition to Grant Simufilam Breakthrough Designation

FDA Denies Petition to Grant Simufilam Breakthrough Designation

The FDA has denied a citizen petition to grant a breakthrough therapy designation for Cassava Science’s investigational Alzheimer’s therapy, simufilam, because the petition was submitted by an individual rather than the company.

In denying the petition submitted last October by Paul Efron, an investor in Cassava, Patrizia Cavazzoni, director of the Center for Drug Evaluation and Research, noted that any request for breakthrough designation could only come from Cassava.

The FDA “denies your request for breakthrough therapy designation of simufilam because you are not the drug sponsor,” she wrote, adding that the Food, Drug and Cosmetic Act specifies that requests for breakthrough therapy designation must be submitted by the sponsor.

A Cassava spokesperson said the company is “broadly aware” that citizen petitions were filed in support of simufilam but that “Cassava is not affiliated with the individuals and is not connected in any way to the filings.”

Cassava Sciences is an American pharmaceutical company based in Austin, Texas. The company was founded in 1998 by chief executive officer and president Remi Barbier as Pain Therapeutics, Inc., changing its name in 2019.

Cassava is developing simufilam (previously known as PTI-125 and sumifilam), an oral-tablet drug candidate for the treatment of Alzheimer's disease; simufilam is in phase III clinical trials as of 2022. Reuters reported on July 27, 2022, that the United States Department of Justice (DOJ) is investigating Cassava Sciences over research results related to the experimental drug. A citizen petition attempting to suspend the clinical trials was filed with the Food and Drug Administration (FDA), but the FDA said that the citizen petition "was not a proper avenue" to stop the trials in February 2022. Cassava Sciences has denied any wrongdoing and raised concerns about the motivations behind the FDA petition. The U.S. Securities and Exchange Commission (SEC), the U.S. National Institutes of Health (NIH), and City University of New York (CUNY) were also investigating allegations of manipulated data.

Cassava (as Pain Therapeutics) initially worked on three drugs: the pain drugs Oxytrex and Remoxy, and PTI-901, which aimed to treat irritable bowel syndrome. The company had no drug approved as of 2021, and no product revenues between 2013 and 2021; with 25 employees, the company's stock was the sixth-best performing in 2021 before falling after the FDA petition.

March 7, 2023


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