Clinical stage pharmaceutical company Promontory Therapeutics Inc on Tuesday announced a successful in-person End of Phase 2 (EOP2) Meeting with the US Food and Drug Administration (FDA), enabling the company to prepare and submit a registrational Phase 3 study of PT-112 monotherapy in patients with metastatic castration-resistant prostate cancer (mCRPC).

In the meeting, the FDA agreed with the proposed dosing regimen for use in a prospective, randomised controlled Phase 3 registrational study. The company will now prepare its full Phase 3 study submission for final review on the basis of the FDA's guidance, and conduct similar meetings with international regulatory authorities.

The proof of concept and dose optimisation Phase 2 study of PT-112 monotherapy in advanced mCRPC was conducted in the United States and France, and included three randomised dosing arms of PT-112.