- Tempest Therapeutics (TPST, Financial) has been granted Orphan Drug Designation by the FDA for TPST-1495, aiming to treat Familial Adenomatous Polyposis (FAP).
- The Phase 2 clinical trial, starting in 2025, is funded by the National Cancer Institute.
- Study results are anticipated in 2026, marking a regulatory milestone for Tempest's second clinical program.
Tempest Therapeutics, Inc. (TPST), a clinical-stage biotechnology company, has announced an important regulatory achievement with the U.S. Food and Drug Administration (FDA) granting Orphan Drug Designation to TPST-1495, intended for the treatment of Familial Adenomatous Polyposis (FAP). TPST-1495 is a novel dual receptor inhibitor targeting prostaglandin (PGE2) signaling. This designation facilitates development by potentially offering benefits such as tax credits and seven years of market exclusivity upon approval.
A Phase 2 clinical trial for TPST-1495 is scheduled to commence in 2025, led by the Cancer Prevention Clinical Trials Network and financed by the National Cancer Institute Division of Cancer Prevention. This study represents Tempest’s second clinical program, with results expected in 2026.
FAP, characterized by the development of numerous adenomatous polyps in the gastrointestinal tract, is a genetic syndrome predisposing individuals to a high risk of cancer. Currently, surgical removal of the colon (colectomy) is the standard care method to prevent cancer, though ongoing surveillance is necessary due to the potential for cancer development elsewhere in the GI tract.
Tempest Therapeutics continues its mission to innovate in the biopharmaceutical sector, advancing small molecule therapeutics for cancer treatment. The company's evolving pipeline ranges from early research to later-stage studies in cancer treatment, underpinning its strategic focus on advancing effective therapies for unmet medical needs.
