CinCor Pharma, Inc. announced 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. Baxdrostat (CIN-107) is a highly selective, oral small molecule inhibitor of aldosterone synthase, the enzyme responsible for the synthesis of aldosterone in the adrenal gland, in development for patient populations with significant unmet medical needs, including treatment-resistant hypertension and primary aldosteronism.

Hypertension, which is defined by the American College of Cardiology and the American Heart Association as resting blood pressure above 130/80 mm Hg, is generally acknowledged to be one of the most common preventable risk factors for premature death worldwide. Though often asymptomatic, hypertension significantly increases the risk of heart disease, stroke, and kidney disease, amongst other diseases. It is estimated that as much as 20% of the global population suffers from hypertension, including nearly one-half of the adult population in the U.S., or 116 million hypertensive patients.