Promontory Therapeutics Announces Successful End of Phase 2 Meeting with US FDA on Phase 3 Registrational Study Design for PT-112 in Patients with Metastatic Castration-Resistant Prostate Cancer
Agreement broadly reached on PT-112 Recommended Phase 3 Dose (RP3D), patient population, study comparator and key study endpoints
Interim analysis allows potential for drug approval prior to study completion
Preliminary PT-112 Phase 2 clinical outcomes in metastatic castration-resistant prostate cancer patients will be presented at the ASCO 2025 Annual Meeting
NEW YORK, May 20, 2025 /PRNewswire/ -- Promontory Therapeutics Inc., a clinical stage pharmaceutical company advancing small molecule oncology approaches with immunotherapeutic effects, today announced a successful in-person End of Phase 2 (EOP2) Meeting with the U.S. Food and Drug Administration (FDA), allowing the company to prepare and submit a registrational Phase 3 study of PT-112 monotherapy in patients with metastatic castration-resistant prostate cancer (mCRPC).
Consistent with FDA Project Optimus, the FDA agreed with the proposed dosing regimen for use in a prospective, randomized controlled Phase 3 registrational study, on the basis of the completed Phase 2 clinical trial. The study design and endpoints, along with the proposed comparator and statistical framework, were agreed in principle, as were Promontory's proposed patient population within mCRPC, and proposal for an interim analysis. The latter would allow a potential pathway for drug approval prior to the full completion of the Phase 3 study.
Promontory will now prepare its full Phase 3 study submission for final review on the basis of FDA's guidance, and conduct similar meetings with international regulatory authorities.
The proof of concept and dose optimization Phase 2 study of PT-112 monotherapy in advanced mCRPC was conducted in the U.S. and France and included three randomized dosing arms of PT-112. Immune response biomarker data were recently presented at the American Association of Cancer Research (AACR) 2025 Annual Meeting, and preliminary clinical outcomes will be presented on June 2nd at the upcoming American Society of Clinical Oncology (ASCO) 2025 Annual Meeting.
For more information about Promontory Therapeutics and PT-112 visit www.PromontoryTx.com.
About Promontory Therapeutics
Promontory Therapeutics Inc. is a privately held, clinical stage drug development company based in New York, focused on small molecules with anti-cancer immune effects. Clinical data generated across six studies of lead molecule PT-112 have demonstrated single-agent and combination anti-cancer activity and an attractive tolerability profile. The Company's lead Phase 2 study in late-stage metastatic castration-resistant prostate cancer patients in the United States and France was the subject of an End of Phase 2 (EOP2) meeting with FDA, with pending regulatory meetings in other jurisdictions. The company has conducted research and development programs in the United States, Europe and Asia. As part of its recent clinical expansion into France, Promontory was selected as the first international company member of the Paris-Saclay Cancer Cluster, Europe's emerging biotech hub for oncology. The company also has an active Phase 2 trial underway at the National Cancer Institute under a Collaborative Research and Development Agreement, assessing PT-112 monotherapy in thymic epithelial tumors, a rare disease with no FDA approved drug, for which Promontory holds FDA Orphan Drug designation.
CONTACTS:
Promontory Therapeutics
Email: info@promontorytx.com
Media
Alexis Feinberg
Email: promontoryPR@icrhealthcare.com
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SOURCE Promontory Therapeutics Inc.