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Cardio-renal drug developer CinCor Pharma (NASDAQ:CINC) lost ~27% pre-market Monday after announcing that its Phase 2 HALO trial for antihypertensive agent baxdrostat did not meet the main goal.
The randomized, multicenter trial was designed to evaluate three doses of baxdrostat (0.5 mg, 1.0 mg, and 2.0 mg) in 249 subjects with uncontrolled hypertension who are under up to two antihypertensive agents at maximally tolerated dosages.
Per the topline data, HALO did not achieve the primary endpoint that tested the change of mean seated systolic blood pressure (SBP) in the intention to treat (ITT) population (n = 249) with statistical significance.
However, a group of non-Hispanic patients (47%, 116/249) representing about 81-89% of the U.S. hypertension population showed a placebo-adjusted SBP reduction of 12.6 mmHg (nominal p-value = 0.001) at the 2 mg dose.
“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,” the medical chief of CinCor (CINC) Mason Freeman said.
In August, the company announced that the BrigHtn trial for baxdrostat met the main goal in patients with treatment-resistant hypertension.
