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CinCor Pharma announces topline data for Phase 2 HALO Trial evaluating selective aldosterone synthase inhibitor baxdrostat in uncontrolled hypertension

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CinCor Pharma
  • 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
  • Conference call and live webcast Nov. 28 at 8:00 AM Eastern Time

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.”

Mason Freeman, M.D., Chief Medical Officer at CinCor added, “While we still need to learn more about the factors driving different responses in our pre-specified sub-group analyses, it is clear that baxdrostat generated double-digit SBP reductions in study sub-groups, which include Black/African American patients, representative of approximately 81-89% of the hypertensive population of the U.S. The data also demonstrate a favorable safety profile and tolerability across the treated patient groups. Patients in HALO were not pre-selected for inclusion on the basis of aldosterone, renin, or other hormonal characteristics, suggesting baxdrostat’s utility in the uncontrolled hypertensive population may be broader than expected. When combined with data from our BrigHtn study of treatment resistant patients, the HALO trial has provided key insights needed to select patient populations and dosing of baxdrostat that we plan to propose to the FDA for our Phase 3 program. We want to thank all the patients and healthcare providers who have contributed to a better understanding of this new mechanistic class.”

Deepak L. Bhatt, M.D., M.P.H., Executive Director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital and Professor of Medicine at Harvard Medical School, further added, “The reductions in systolic blood pressure levels among the patients from HALO who were adherent to study drug are consistent with the overall positive data from BrigHtn. HALO also reconfirms the safety profile of baxdrostat. The data from these two trials provides the necessary dosing, safety, and target population information CinCor needs to design and execute its Phase 3 programs in resistant and uncontrolled hypertension. I am excited to continue working with the Company to help them investigate the safety and effectiveness of baxdrostat in potentially providing improved treatment options for the large numbers of patients whose hypertension remains refractory to current therapies.”

Read the full press release on CinCor.com

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