CinCor Pharma, Inc., Doses First Patient in HALO, a Phase 2 Clinical Trial Evaluating Selective Aldosterone Synthase Inhibitor in Patients With Uncontrolled Hypertension & High Plasma Aldosterone

CinCor Pharma, Inc. recently announced the dosing of the first patient in its Phase 2 clinical trial evaluating CIN-107, a highly selective, oral small molecule inhibitor of aldosterone synthase, in patients with uncontrolled hypertension and elevated plasma aldosterone levels, referred to as the High ALdOsterone (HALO) trial.

The HALO trial is a randomized, double-blind, placebo-controlled, multicenter, parallel-group, clinical trial designed to assess the safety and efficacy of CIN-107. Two-hundred-fifty patients with systolic blood pressure (SBP) greater than 140 mm Hg, or greater than 130 mm Hg if the patient is diabetic, will be enrolled. All patients will be on one antihypertensive agent and have a plasma aldosterone level greater than 6 or 7 ng/dL depending on which background anti-hypertensive they are taking. Patients will be randomly assigned to four cohorts (placebo, 0.5 mg, 1.0 mg and 2.0 mg of CIN-107). The primary endpoint is the change in SBP after eight weeks of treatment. The study is being conducted at approximately 70 clinical sites in the US. More information on the trial can be found on clinicaltrials.gov at NCT5137002.

“Elevated levels of aldosterone stimulate salt and water retention, which can result in elevated blood pressure,” said Mason Freeman, MD, Executive Vice President, Clinical Development at CinCor. “HALO is testing the hypothesis that hypertensive patients with higher levels of circulating aldosterone may achieve substantial blood pressure reductions when dosed with CIN-107, which is designed to specifically inhibit aldosterone synthesis and lower blood aldosterone levels. This trial, along with our ongoing Phase 2 BrigHtn clinical trial in patients with treatment resistant hypertension, are intended to generate data that we believe could position CIN-107 as a differentiated and important treatment option for several groups of hypertensive patients who struggle to lower their blood pressure to recommended levels.”

CIN-107 is a highly selective, oral small molecule inhibitor of aldosterone synthase, the enzyme responsible for the synthesis of aldosterone in the adrenal gland. Hypertension, which is defined by the American College of Cardiology and the American Heart Association as resting blood pressure above 130/80 mm Hg, is generally acknowledged to be one of the most common preventable risk factors for premature death worldwide. Though often asymptomatic, hypertension significantly increases the risk of heart disease, stroke and kidney disease, amongst other diseases. It is estimated that as much as 20% of the global population suffers from hypertension, including nearly one-half of the adult population in the US (108 million patients).

CinCor, founded in 2018, is a clinical-stage biopharmaceutical company with a mission to bring innovation to the pharmaceutical treatment of cardio-renal diseases. Our lead asset, CIN-107, a highly selective, oral small molecule inhibitor of aldosterone synthase, is in clinical development for the treatment of hypertension and primary aldosteronism. CinCor has raised $192 million to date.