Mineralys Therapeutics, Inc. (Nasdaq: MLYS) has announced the completion of enrollment in its pivotal Advance-HTN and Phase 3 Launch-HTN trials evaluating lorundrostat for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN). The company anticipates topline data from these trials in the first half of 2025, which will form the basis for a potential NDA submission to the FDA.
Advance-HTN Trial
The Advance-HTN trial is evaluating the efficacy and safety of lorundrostat as an add-on therapy to a standardized background treatment in patients with uHTN or rHTN. The trial has completed enrollment, and topline data is expected in March 2025. Key characteristics of the enrolled subjects include a diverse population with over 66% having a BMI equal to or greater than 30kg/m2, more than 40% women, and more than 50% of Black or African American race. The primary endpoint is the change in 24-hour ambulatory systolic blood pressure at week twelve from baseline for active cohorts versus placebo.
Launch-HTN Phase 3 Trial
The Launch-HTN trial, the second pivotal trial of lorundrostat, has also completed enrollment ahead of schedule. This trial is assessing lorundrostat as an add-on therapy for subjects with uHTN or rHTN who have not achieved blood pressure control on their existing regimen of two to five antihypertensive medications. Topline data is anticipated in mid first half of 2025. The primary endpoint is the change from baseline in systolic blood pressure versus placebo after six weeks of treatment, measured by automated office blood pressure monitoring.
Explore-CKD Phase 2 Trial
Enrollment is ongoing in the Explore-CKD Phase 2 trial, with topline data expected in the second quarter of 2025. This trial is designed to evaluate the safety and efficacy of lorundrostat when added to background treatment with an SGLT2 inhibitor as a potential therapy for patients with uHTN or rHTN and Stage 2 to 3b CKD.
Transform-HTN Open-Label Extension Trial
The company’s ongoing open-label extension trial allows subjects to continue to receive lorundrostat and obtain additional safety and efficacy data.
Financial Highlights
As of September 30, 2024, Mineralys Therapeutics reported cash, cash equivalents, and investments of $263.6 million, compared to $239.0 million as of December 31, 2023. The company believes its current financial resources will be sufficient to fund planned clinical studies and support corporate operations into 2026.
About Lorundrostat
Lorundrostat is an orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uHTN, rHTN, and CKD. It is designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for aldosterone production. In a Phase 2 trial (Target-HTN), lorundrostat demonstrated clinically meaningful blood pressure reduction in uncontrolled or resistant hypertensive subjects.
