Mineralys Therapeutics Announces Journal of the American Medical Association (JAMA) Publication of Pivotal Phase 3 Launch-HTN Trial for Lorundrostat

Core Insights - The Launch-HTN trial is the largest trial of an aldosterone synthase inhibitor for uncontrolled or treatment-resistant hypertension [1][2] - Lorundrostat 50 mg once daily showed significant reductions in systolic blood pressure, with a 16.9 mmHg reduction at Week 6 and a 19.0 mmHg reduction at Week 12 [1][5] - The trial demonstrated a favorable safety profile, with treatment-emergent adverse events being mostly mild and transient [1][6] Company Overview - Mineralys Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing treatments for hypertension, chronic kidney disease (CKD), and obstructive sleep apnea (OSA) driven by dysregulated aldosterone [1][11] - The company’s lead product candidate, lorundrostat, is a highly selective aldosterone synthase inhibitor designed to reduce aldosterone levels [10][11] Trial Details - The Launch-HTN trial was a global, randomized, double-blinded, placebo-controlled Phase 3 trial involving 1,083 participants who were on two to five antihypertensive medications [4] - The trial utilized automated office blood pressure measurements and allowed participants to continue their existing medications, reflecting real-world clinical practice [4] Efficacy Results - Lorundrostat demonstrated statistically significant mean reductions in automated office blood pressure, with a placebo-adjusted reduction of -9.1 mmHg at Week 6 and -11.7 mmHg at Week 12 [5] - The efficacy of lorundrostat was consistent across various demographics, including age, sex, race, body mass index, and baseline medication regimen [5] Safety Profile - The safety and tolerability profile of lorundrostat was favorable, with only a small percentage of participants experiencing elevated serum potassium levels [6][7] - There was no observed suppression of cortisol production, and serious adverse events leading to discontinuation were very low [7] Industry Context - Hypertension is a leading cause of cardiovascular disease, with less than 50% of patients achieving their blood pressure goals with current medications [8][9] - Dysregulated aldosterone levels contribute to hypertension in approximately 30% of hypertensive patients, highlighting the need for effective treatments like lorundrostat [9]