CinCor Pharma Sinks After Disappointing Data From Hypertension Trial
CinCor Pharma Inc (NASDAQ: 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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