CinCor Pharma Announces Topline Data for Phase 2 HALO Trial Evaluating Selective Aldosterone Synthase Inhibitor Baxdrostat in Uncontrolled Hypertension

Primary endpoint in Intention to Treat (ITT) was not met despite large absolute reductions in Systolic Blood Pressure (SBP)

12.6 mmHg placebo-adjusted reduction in SBP with 2 mg baxdrostat in a pre-specified subgroup that represents approximately 81-89% of the U.S. hypertension population (nominal p-value = 0.001)

Safety profile and tolerability consistent with BrigHtn Phase 2 data; no patient discontinued due to treatment-related adverse events; low hyperkalemia incidence

HALO in combination with BrigHtn informs the dose and study populations anticipated to be recruited into Phase 3 trials pending confirmation by FDA at planned end of Phase 2 meeting in January 2023; Phase 3 trials expected to begin first half of 2023

Baxdrostat’s clinical program remains on track for a potential NDA submission in 2025

Excerpt from the Press Release:

WALTHAM, Mass., Nov. 28, 2022 (GLOBE NEWSWIRE) —  CinCor Pharma, Inc. (“CinCor”) announced today the topline results and completion of its Phase 2 HALO trial evaluating the efficacy and safety of baxdrostat in patients with uncontrolled hypertension taking up to two blood pressure medications at the maximally tolerated doses. Baxdrostat is a once daily potentially first-in-class, highly selective aldosterone synthase inhibitor. While HALO did not achieve statistical significance on its primary endpoint evaluating change from baseline in mean seated systolic blood pressure (SBP) in the intention to treat (ITT) population (n = 249), a pre-specified subgroup analysis of non-Hispanic patients (47%, 116/249) representing approximately 81-89% of the hypertension population in the United States, demonstrated a placebo-adjusted reduction in SBP of 12.6 mmHg (nominal p-value = 0.001) at the 2 mg dose. The safety profile and tolerability of baxdrostat was consistent with previously reported Phase 2 BrigHtn data in resistant hypertension.

“We are pleased HALO has achieved our prospective goal of better understanding which patients respond best to baxdrostat, as well as further confirming baxdrostat’s safety profile and tolerability,” said Marc de Garidel, Chief Executive Officer at CinCor. “The results of the two Phase 2 trials, involving over 500 patients of diverse backgrounds, enable us to maintain our previously announced plans to meet with the FDA in January 2023 at an end of Phase 2 meeting to discuss our Phase 3 program plans. Following that meeting, we anticipate initiating our pivotal Phase 3 trials in the first half of 2023. We are very excited about developing a potentially well differentiated drug to address the unmet medical need of tens of millions of uncontrolled and resistant hypertension patients in the U.S. alone.”

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