RADNOR, PA — Mineralys Therapeutics, Inc. (Nasdaq: MLYS) has reached a critical milestone in its quest to revolutionize hypertension treatment. The company recently announced that the first subject in the Launch-HTN pivotal trial has been administered lorundrostat, an investigational drug for uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), as an add-on therapy.
Jon Congleton, Chief Executive Officer of Mineralys, expressed optimism about the progress. He underscored the importance of identifying potential responders to lorundrostat, indicating a targeted approach to hypertension care. Congleton also noted the growing evidence pointing towards aldosterone as a crucial factor in cardiorenal disease.
The Launch-HTN trial is the second of two clinical studies designed to evaluate lorundrostat’s safety and efficacy when added to existing hypertension treatments. The trial aims to reflect real-world treatment scenarios for uHTN and rHTN in primary care settings. A global, randomized, double-blinded, placebo-controlled Phase 3 study, Launch-HTN plans to enroll up to approximately 1,000 eligible adult participants who aren’t achieving their blood pressure goals despite taking two to five antihypertensive medications.
Participants will be randomized into one of three groups: a placebo group, a group receiving a once-daily dose of 50mg lorundrostat, and a group starting with a 50mg dose of lorundrostat and potentially titrating up to 100mg at week six. The trial’s primary endpoint is the change in systolic blood pressure from baseline versus placebo after 12 weeks of treatment, measured by automated office blood pressure monitoring.
This development follows the company’s announcement in May 2023 that the first subject was dosed in the first pivotal trial, Advance-HTN. Mineralys expects to release topline data from the Advance-HTN trial in the second half of 2024. Participants in both the Advance-HTN and Launch-HTN trials are given the opportunity to participate in the open-label extension trial, Transform-HTN.
This significant progress in Mineralys’ pivotal trials brings the company one step closer to potentially offering a new add-on therapy for hypertension treatment, which could be a game-changer for patients struggling with uncontrolled and resistant hypertension.
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