Mineralys Therapeutics(US:MLYS) Globenewswireยท2025-04-23 21:23Core Insights - Mineralys Therapeutics has published significant results from the Phase 2 Advance-HTN trial, demonstrating the efficacy of lorundrostat in reducing blood pressure in patients with uncontrolled or resistant hypertension [1][3] - The publication in the New England Journal of Medicine highlights the potential of lorundrostat as a transformative treatment targeting dysregulated aldosterone, a key factor in hypertension [3][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 [1][10] - The company's lead product, lorundrostat, is a highly selective aldosterone synthase inhibitor designed to lower aldosterone levels and improve blood pressure control [7][10] Clinical Trial Results - The Advance-HTN trial showed that lorundrostat 50 mg resulted in a 15.4 mmHg absolute reduction and a 7.9 mmHg placebo-adjusted reduction in 24-hour ambulatory blood pressure at week 12 [2][9] - The trial included patients on optimized antihypertensive regimens, demonstrating that lorundrostat is effective regardless of the number of baseline medications [2][3] Safety and Tolerability - Lorundrostat exhibited a favorable safety profile with modest changes in potassium, sodium, and estimated glomerular filtration rate (eGFR) [2][3] - Adverse events reported in the trials included a modest increase in serum potassium and a decrease in eGFR, with one serious adverse event of hyponatremia possibly related to the study drug [8][9] Future Developments - Mineralys plans to present additional data from the Phase 3 Launch-HTN trial at an upcoming medical conference and in a peer-reviewed publication [4] - The ongoing Transform-HTN trial will provide further safety and efficacy data as subjects continue to receive lorundrostat [4]