Mineralys Therapeutics(MLYS) Newsfilter·2025-03-10 11:00Core Insights - Mineralys Therapeutics announced positive topline data from its pivotal Launch-HTN Phase 3 and Advance-HTN Phase 2 trials for lorundrostat, demonstrating significant efficacy and safety in treating uncontrolled and resistant hypertension [2][3] Efficacy Results - The Launch-HTN trial achieved a 16.9 mmHg reduction in systolic blood pressure at week 6 and a 19.0 mmHg reduction at week 12, with placebo-adjusted reductions of 9.1 mmHg and 11.7 mmHg respectively (p-value < 0.0001) [1][5] - The Advance-HTN trial reported a 7.9 mmHg placebo-adjusted reduction in systolic blood pressure at week 12 [1][6] - Both trials demonstrated clinically meaningful and statistically significant results, supporting the potential of lorundrostat as a new treatment option for approximately 15 to 20 million patients with uncontrolled hypertension in the U.S. [3][4] Safety and Tolerability - Lorundrostat exhibited a favorable safety and tolerability profile across both pivotal trials, with low incidences of serious adverse events and manageable side effects [8][14] - The incidence of hyperkalemia was reported at 1.1% and 1.5% in the Launch-HTN trial and 5.3% and 7.4% in the Advance-HTN trial [14] Future Developments - Full results from the Advance-HTN trial are scheduled to be presented on March 29, 2025, at the American College of Cardiology Scientific Sessions [1][7] - The ongoing Transform-HTN open-label extension trial will continue to gather safety and efficacy data for lorundrostat [10] Company Overview - Mineralys Therapeutics is focused on developing treatments for hypertension, chronic kidney disease, and obstructive sleep apnea, with lorundrostat being its lead candidate [2][19] - The company aims to address the significant unmet medical need in hypertension, where less than 50% of patients achieve their blood pressure goals with current medications [12][13]