RADNOR, PA — Mineralys Therapeutics, Inc. (Nasdaq: MLYS) announced the publication of groundbreaking Phase 2 trial results for its medication lorundrostat in the New England Journal of Medicine (NEJM). The Advance-HTN trial evaluated the drug’s effectiveness in patients with uncontrolled hypertension (uHTN) and resistant hypertension (rHTN).
According to the study, lorundrostat 50 mg demonstrated a reduction of 15.4 mmHg in ambulatory systolic blood pressure over 24 hours, with a placebo-adjusted reduction of 7.9 mmHg after 12 weeks (p=0.001). These results were consistent across diverse patient groups, regardless of sex, race, or baseline medication regimen. Additionally, lorundrostat presented a favorable safety profile with minimal effects on potassium, sodium, and kidney function.
“The publication of our Advance-HTN trial results in the New England Journal of Medicine is a significant milestone,” said Jon Congleton, CEO of Mineralys Therapeutics. “The findings underscore the potential of lorundrostat to address dysregulated aldosterone, a key driver of hypertension.”
Dr. Luke Laffin, lead author of the study and co-director at Cleveland Clinic’s Center for Blood Pressure Disorders, highlighted the drug’s unique mechanism. “Currently available therapies do not target aldosterone production, which is crucial in cases of uncontrolled or resistant hypertension. The results further validate aldosterone’s role in hypertension pathogenesis,” he stated.
Lorundrostat, an aldosterone synthase inhibitor, is designed to reduce elevated aldosterone levels by targeting CYP11B2, an enzyme responsible for its production. The drug offers a novel approach to treating hypertension, which affects nearly half of U.S. adults and contributes to over 670,000 deaths annually. Existing treatments fail to control blood pressure in more than 50% of patients, highlighting the need for innovative solutions like lorundrostat.
The Advance-HTN results follow a presentation at the American College of Cardiology’s Annual Scientific Session and mark a stepping-stone toward Mineralys’ Phase 3 Launch-HTN trial, with findings expected to be shared at an upcoming medical conference. The company also continues its Transform-HTN extension trial to gather additional safety and efficacy data.
Mineralys Therapeutics remains focused on addressing unmet medical needs in hypertension management, with lorundrostat paving the way for more targeted and effective treatments in this critical healthcare space.
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