Mineralys Therapeutics announces publication of Phase 3 Launch-HTN trial results

Mineralys Therapeutics (MLYS) announced the publication of the results from the pivotal Phase 3 Launch-HTN trial in the Journal of the American Medical Association. The manuscript titled “Lorundrostat in Participants with Uncontrolled and Treatment-Resistant Hypertension” is featured in the June 30, 2025 issue. The Launch-HTN trial evaluated the efficacy and safety of lorundrostat, a novel aldosterone synthase inhibitor, when added to existing background treatment in 1,083 participants with uncontrolled or treatment resistant hypertension. The trial demonstrated that lorundrostat significantly reduced systolic blood pressure with a favorable safety and tolerability profile. The Launch-HTN trial was a global, randomized, double-blinded, placebo-controlled Phase 3 trial, which enrolled 1,083 eligible adult participants who failed to achieve their BP goal despite being on two to five antihypertensive medications. Launch-HTN reflects the real-world setting for clinicians by utilizing automated office blood pressure measurements and allowing participants to stay on their existing medications. Authors noted that the trial recruited a diverse population as reflected in the high proportion of females, Black or African American and elderly participants. When added to existing background treatment, lorundrostat 50 mg dosed once daily demonstrated clinically meaningful, statistically significant mean reductions in AOBP with a 16.9 mmHg reduction at Week 6 that was sustained with a reduction of 19.0 mmHg at Week 12. These benefits were consistent across age, sex, race, body mass index, and baseline medication regimen. Lorundrostat demonstrated a favorable safety and tolerability profile in the Launch-HTN trial. The anticipated on-target effects on serum electrolytes, increased serum potassium and reduced serum sodium were modest and rapidly reversible upon discontinuation of lorundrostat. A confirmed serum potassium level of greater than 6.0 mmol/L occurred in three subjects on lorundrostat 50 mg once daily, as compared to one subject on placebo. Suppression of cortisol production was not observed, and there was a very low incidence of drug-related serious adverse events resulting in discontinuation or dose-adjustment of study medication.