Mineralys Therapeutics(US:MLYS) Newsfilterยท2025-09-05 13:00Core Insights - The Launch-HTN trial of lorundrostat, a novel aldosterone synthase inhibitor, shows significant blood pressure reductions in diverse high-risk populations with uncontrolled hypertension [1][2][3] - The trial enrolled 1,083 participants, making it the largest global Phase 3 trial for uncontrolled or resistant hypertension [7] - Lorundrostat demonstrated a favorable safety and tolerability profile, with no new safety signals observed [6][9] Company Overview - Mineralys Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing treatments for hypertension and related conditions driven by dysregulated aldosterone [1][15] - The company plans to file a New Drug Application (NDA) for lorundrostat in late 2025 or early 2026 [10] Trial Details - The Launch-HTN trial utilized automated office blood pressure measurements and allowed participants to continue existing antihypertensive medications [7][12] - Key demographics included 29% Black/African American, 41% aged 65 or older, and 63% with obesity [2][3] Efficacy Results - Lorundrostat 50 mg showed consistent, statistically significant reductions in blood pressure across various subgroups, including a 16.9 mmHg reduction at Week 6 [8][4] - The trial results indicated that lorundrostat could address critical unmet medical needs in high-risk patient cohorts [3][4] Safety Profile - The safety outcomes were favorable, with adverse events generally mild or moderate, and no significant new safety concerns identified [6][9] - The incidence of serious adverse events leading to discontinuation was very low [9] Future Directions - Mineralys is moving forward with its NDA filing strategy and has scheduled a pre-NDA meeting with the FDA [10] - The company aims to evaluate lorundrostat for potential treatment of chronic kidney disease and obstructive sleep apnea in addition to hypertension [13][15]