Mineralys Therapeutics, Inc. announced positive data from the Target-HTN Phase 2 study that demonstrated clinically meaningful blood pressure reduction with once-daily dosing of lorundrostat at the American College of Cardiology's 72nd Annual Scientific Session together with the World Congress of Cardiology (ACC.23/WCC) going on now in New Orleans, LA. In a pre-specified analysis, hypertensive subjects with a BMI =30 kg/m2, demonstrated a statistically significant reduction of placebo-adjusted change in systolic blood pressure (BP) of 16.7 mmHg (p=0.002) with 50mg QD and a reduction of 12.3 mmHg (p=0.030) with 100 mg QD in Part 1 of the study. The data from this sub-analysis of the Phase 2 study were presented in a moderated poster titled, ‘Highly Effective Blood Pressure Lowering with lorundrostat, a New Aldosterone Synthase Inhibitor, in Individuals with Obesity and RAAS Dysregulation' at the ACC.23/WCC.

Initial topline results from the Target-HTN Phase 2 trial demonstrated that treatment with lorundrostat at doses of 50 mg and 100 mg once daily (QD) led to a statistically significant reduction in systolic BP in inadequately controlled hypertensive patients on at least two background antihypertensive medications. Robust placebo-adjusted reductions in systolic BP and diastolic BP were observed in the office, as well as in the home with 24-hour ambulatory blood pressure monitoring demonstrating reduction of 24-hour average systolic BP, night-time systolic BP, and central systolic BP. The Target-HTN (NCT05001945) study was a Phase 2 randomized, double-blind, placebo-controlled, dose-ranging, multicenter trial conducted in the U.S. The trial was designed to evaluate the safety, efficacy, and tolerability of orally administered lorundrostat on BP for the treatment of uncontrolled and resistant hypertension when used as add-on therapy to stable background treatment of two or more antihypertensive agents in 200 male and female subjects 18 years of age or older.

Five active doses of lorundrostat (12.5 mg QD, 50 mg QD, 100 mg QD, 12.5 mg twice daily [BID], and 25 mg BID) were compared to placebo in hypertensive subjects. Adverse events observed were a modest increase in serum potassium, decrease in estimated glomerular filtration rate, urinary tract infection and hypertension with one serious adverse event possibly related to study drug being hyponatremia. During ACC.23/WCC, the Company will also present Phase 1 data for lorundrostat that is included in a poster titled, ‘First-In-Human Study of lorundrostat, a Potent and Highly Selective Aldosterone Synthase Inhibitor'.