Mineralys Therapeutics Unveils Positive Data From Two Trials For Hypertension Drug Candidate

Core Insights - Mineralys Therapeutics, Inc. released positive topline data from its pivotal Launch-HTN Phase 3 and Advance-HTN Phase 2 trials for lorundrostat, indicating significant efficacy in treating uncontrolled and resistant hypertension [1] Group 1: Trial Results - The Launch-HTN trial achieved its primary endpoint, with a 50 mg dose of lorundrostat resulting in a 16.9 mmHg reduction in systolic blood pressure and a 9.1 mmHg placebo-adjusted reduction at week 6 [2] - An alternative report from the Launch-HTN trial indicated a 19.0 mmHg reduction in systolic blood pressure and an 11.7 mmHg placebo-adjusted reduction [3] - The Advance-HTN trial also met its primary endpoint, showing a placebo-adjusted reduction of 7.9 mmHg in systolic blood pressure at week 12 [4] Group 2: Safety Profile - Clinical safety findings from both pivotal trials indicated a favorable benefit-risk profile, with assessments of hypotension, serum potassium, eGFR, and serum cortisol [4] Group 3: Future Developments - In February, the company completed enrollment in the Explore-CKD Phase 2 trial, which evaluates lorundrostat's efficacy and safety for hypertension in subjects with chronic kidney disease and albuminuria [5] - The FDA cleared an Investigational New Drug (IND) application for a Phase 2 trial of lorundrostat targeting moderate-to-severe obstructive sleep apnea and hypertension, with the trial expected to start in Q1 2025 [6] Group 4: Market Reaction - Following the positive trial results, MLYS stock increased by 65.70%, reaching $17.43 [6]