Mineralys Therapeutics Announces Late-Breaking Data from Advance-HTN Pivotal Trial of Lorundrostat in Uncontrolled and Resistant Hypertension Presented at the American College of Cardiology's Annual Scientific Session & Expo (ACC.25)

Core Insights - Lorundrostat 50 mg achieved a 15.4 mmHg absolute reduction and a 7.9 mmHg placebo-adjusted reduction in blood pressure at week 12, demonstrating a favorable safety and tolerability profile [1][3] - Lorundrostat is a selective aldosterone synthase inhibitor that targets aldosterone biosynthesis, making it a potential best-in-class treatment for high-risk patients with uncontrolled or resistant hypertension [1][12] - The Advance-HTN trial results support lorundrostat's clinical utility across diverse care settings, addressing a significant unmet need in hypertension management [2][7] Efficacy Results - The Advance-HTN trial was a randomized, double-blind, placebo-controlled Phase 2 trial evaluating lorundrostat's efficacy and safety in patients with uncontrolled or resistant hypertension [3][14] - The primary endpoint was the change in 24-hour average systolic blood pressure (SBP) at week 12, with significant reductions observed [4][14] - Key secondary endpoints included a 7.9 mmHg placebo-adjusted change at week 4, with a notable proportion of patients achieving SBP < 125 mmHg [5][4] Safety and Tolerability - Lorundrostat exhibited a favorable safety profile with modest changes in potassium, sodium, and estimated glomerular filtration rate (eGFR), alongside a low discontinuation rate [6][7] - The incidence of serious adverse events was very low, reinforcing lorundrostat's potential as a well-tolerated therapy for high-risk patients [7][10] - Hyperkalemia incidence was confirmed at 2.1% and 3.2% for the 50 mg and 50 to 100 mg arms, respectively, after validation procedures [10] Company Overview - Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for hypertension, chronic kidney disease, and obstructive sleep apnea driven by dysregulated aldosterone [15] - The company is based in Radnor, Pennsylvania, and aims to address significant health issues related to hypertension, which has a substantial economic burden in the U.S. [9][15] - Mineralys plans to present additional data from the Phase 3 Launch-HTN trial at upcoming medical conferences [7]