Tempest Therapeutics has received FDA clearance for a Phase 2 clinical trial of TPST-1495, a dual prostaglandin E2 (PGE2) receptor inhibitor, for Familial Adenomatous Polyposis (FAP). The trial, funded by the National Cancer Institute and conducted by the Cancer Prevention Clinical Trials Network, will begin in 2025 with data expected in 2026. This marks Tempest’s second clinical program to enter Phase 2.
This development is particularly important for FAP patients who have undergone colectomy, as they face a high risk of developing duodenal polyps and subsequent cancers. Current treatment options are limited, highlighting the need for novel preventative therapies. The initiation of this Phase 2 trial addresses this unmet need by exploring the potential of TPST-1495 to reduce duodenal polyp burden and improve patient outcomes. This collaboration between Tempest, the NCI, and the Cancer Prevention Clinical Trials Network underscores the importance of public-private partnerships in accelerating the development of cancer prevention strategies.
The Phase 2 trial will evaluate TPST-1495’s efficacy and safety in FAP patients post-colectomy. The primary endpoint is the reduction in duodenal polyp burden after six months of treatment. Secondary endpoints include assessing polyp reduction in the retained rectum or ileal pouch-anal anastomosis (IPAA) and the drug’s overall safety profile.
A successful Phase 2 trial could significantly advance TPST-1495 towards potential FDA approval, offering a much-needed preventative treatment option for FAP patients. Positive results would validate Tempest’s approach to targeting PGE2 signaling in cancer and potentially open avenues for its application in other cancer types. This advancement strengthens Tempest’s pipeline and positions them as a key player in developing innovative cancer therapies.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
