- CinCor Pharma Inc CINC announced topline results and completion of its Phase 2 HALO trial of baxdrostat in patients with uncontrolled hypertension taking up to two blood pressure medications at the maximally tolerated doses.
- The study 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.
- The data exhibited a placebo-adjusted reduction in SBP of 12.6 mmHg at the 2 mg dose. The safety profile and tolerability of baxdrostat were consistent with previously reported Phase 2 BrigHtn data in resistant hypertension.
- The trial showed a statistically significant reduction in SBP in the prespecified non-Hispanic subgroup analysis.
- The non-Hispanic population of HALO represented 46% (116/249) of the ITT population in the study but represented approximately 81-89% of the hypertensive population of the U.S.
- In combination with BrigHtn, HALO informs the dose and study populations anticipated to be recruited into Phase 3 trials pending confirmation by the FDA at the planned end of Phase 2 meeting in January 2023. Phase 3 trials are expected to begin in the first half of 2023.
- Baxdrostat’s clinical program remains on track for a potential NDA submission in 2025.
- Price Action: CINC shares are down 47.68% at $13.88 on the last check Monday.
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