CinCor Pharma Announces Receipt Of Minutes From End-Of-Phase 2 Meeting With The U.S. Food And Drug Administration On Planned Phase 3 Program Of Baxdrostat
CinCor Pharma, Inc. ("CinCor" or the "Company") announced today completion of an End-of-Phase 2 meeting with the U.S. Food and Drug Administration ("FDA") on the anticipated Phase 3 program for baxdrostat in hypertension. Baxdrostat is a once daily potentially first-in-class, highly selective aldosterone synthase inhibitor.
On February 17, 2023, the Company received the official meeting minutes from the End-of-Phase 2 meeting with the FDA held on January 18, 2023 reflecting that the FDA has agreed with the Company on (1) the dosing cohorts to be used in the planned Phase 3 program, (2) the size of the required treated patient population for purposes of determining safety and (3) the overall endpoints and patient population size to be treated in the anticipated Phase 3 clinical program. In addition, the FDA indicated that no further Phase 1 or Phase 2 clinical trials are needed prior to initiation of the pivotal Phase 3 program. The Company anticipates that the Phase 3 program is on track to initiate in the first half of 2023.