Tempest Therapeutics (TPST), a clinical-stage biotechnology company focused on cancer therapies, announced Thursday that it has received a "Study May Proceed" letter from the U.S. Food and Drug Administration or FDA for its Phase 2 clinical trial of TPST-1495, a novel dual receptor inhibitor of prostaglandin or PGE2 signaling, for the treatment of Familial Adenomatous Polyposis or FAP.
The clearance follows the successful submission of the IND application for evaluating TPST-1495 in patients with FAP, a high-risk condition that significantly increases the risk of gastrointestinal cancers.
The Phase 2 trial will be conducted in collaboration with the Cancer Prevention Clinical Trials Network and supported by the National Cancer Institute or NCI.
The study aims to evaluate the efficacy and safety of TPST-1495 in reducing duodenal polyp burden in FAP patients, with additional objectives to assess polyp burden reduction in the retained rectum or IPAA.
This IND clearance represents a significant milestone for Tempest and its commitment to developing innovative treatments for cancer prevention. The trial is set to begin later this year, with results expected in 2026.
Currently, TPST is trading at $0.85 up by 5.19 percent on the Nasdaq.
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