RADNOR, PA — Mineralys Therapeutics, Inc. (Nasdaq: MLYS) has announced that the findings from its pivotal Phase 3 Launch-HTN trial on lorundrostat, a novel medication targeting uncontrolled hypertension (uHTN) and resistant hypertension (rHTN), will be presented during a late-breaking clinical trials session at the upcoming 34th European Meeting on Hypertension and Cardiovascular Protection (ESH 2025). The session will take place on May 24 from 10 to 11 a.m. CEST at the MICO Congress Center in Milan.
The Launch-HTN study evaluates lorundrostat, an orally administered, highly selective aldosterone synthase inhibitor. By targeting CYP11B2, the enzyme responsible for aldosterone production, lorundrostat is designed to significantly reduce plasma aldosterone levels. The drug demonstrated a 374-fold selectivity for aldosterone-synthase inhibition over cortisol-synthase inhibition in preclinical studies.
A Promising Treatment for Hypertension
Hypertension remains a critical global health challenge, particularly for patients whose conditions are uncontrolled or resistant to existing therapies. Lorundrostat exhibited encouraging results in the prior Phase 2 Target-HTN trial. Patients recorded substantial reductions in blood pressure through both automated office blood pressure measurements and 24-hour ambulatory monitoring.
Additional findings from the Target-HTN trial revealed notable safety data, with manageable side effects including modest increases in serum potassium levels, minor kidney filtration changes, and isolated adverse events like urinary tract infections and, in one serious case, hyponatremia.
Dr. Manish Saxena, a renowned hypertension specialist, will deliver the presentation, titled Phase 3 Efficacy and Safety of a Novel Aldosterone Synthase Inhibitor in Patients with Uncontrolled and Treatment-Resistant Hypertension, at the MICO venue’s Aqua 1 location. Dr. Saxena is affiliated with Barts Health NHS Trust and the William Harvey Heart Centre at Queen Mary University London.
Advancing the Hypertension Treatment Landscape
Lorundrostat’s potential to directly address aldosterone levels positions the drug as a game-changing therapy, particularly for patients who struggle to control blood pressure despite multiple medications. With an observed half-life of 10-12 hours and the ability to achieve a 70% reduction in plasma aldosterone concentration, Mineralys aims to broaden the treatment landscape for uHTN and rHTN patients as well as those with chronic kidney disease (CKD).
The Phase 3 Launch-HTN trial reflects Mineralys’ commitment to addressing an unmet medical need for innovative hypertension solutions. Its focus on advancing precision therapeutics places lorundrostat at the forefront of efforts to improve outcomes in cardiovascular health.
For healthcare providers, researchers, and patients alike, the presentation at ESH 2025 marks a significant step toward realizing the potential of lorundrostat in improving the quality of life for those living with challenging hypertensive conditions.
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