Mineralys Therapeutics(US:MLYS) Globenewswireยท2025-11-07 23:10Core Insights - Mineralys Therapeutics presented clinical data for lorundrostat at ASN Kidney Week 2025, highlighting its potential in treating hypertension and chronic kidney disease (CKD) [1][2] - The Explore-CKD trial demonstrated significant reductions in blood pressure and albuminuria, supporting the drug's efficacy [2][4] - The Launch-HTN trial was recognized in the "Best of JAMA and NEJM" session, showcasing lorundrostat's robust performance in managing resistant hypertension [2][4] Clinical Trial Results - The Explore-CKD trial (NCT06150924) showed a 9.3 mmHg reduction in automated office systolic blood pressure (AOSBP) and a 25.6% reduction in urinary albumin-to-creatinine ratio (UACR) after four weeks of treatment with lorundrostat [2][7] - The Launch-HTN trial reported a 16.9 mmHg absolute reduction in systolic blood pressure at week 6 and a 19 mmHg reduction at week 12, with significant placebo-adjusted results [4][10] Safety and Tolerability - Lorundrostat exhibited a favorable safety profile, with serious adverse events occurring in only 3% of participants during treatment, compared to none in the placebo group [3][5] - Discontinuations due to treatment-emergent adverse events were low, indicating good tolerability among participants [3] Broader Implications - The results from both trials suggest that lorundrostat could address the growing burden of cardio-renal-metabolic diseases, particularly in high-risk populations [2][5] - The ongoing Transform-HTN study aims to evaluate the long-term safety and efficacy of lorundrostat, further supporting its clinical potential [5][6] Company Overview - Mineralys Therapeutics is focused on developing therapies targeting hypertension and related comorbidities, with lorundrostat as its lead candidate [1][16] - The company aims to file a New Drug Application (NDA) with the FDA by late 2025 or early 2026, based on the promising results from its clinical trials [2][15]