Mineralys Therapeutics, Inc. (NASDAQ: MLYS) has announced that it has successfully completed enrollment in the launch-htn trial ahead of schedule. The trial is the second of two trials under the planned pivotal program evaluating the efficacy and safety of lorundrostat for the treatment of uncontrolled hypertension (UHTN) or resistant hypertension (RHTN).
The company expects the trial to be completed earlier than planned, with topline data now anticipated in mid first half of 2025. The launch-htn trial is a global, randomized, double-blinded, placebo-controlled phase 3 trial that enrolled eligible adult participants who had failed to achieve their blood pressure goal despite being on two to five background antihypertensive medications.
Participants were randomized to one of three arms: placebo, lorundrostat 50 mg once daily (QD), and lorundrostat 50 mg QD and then titrated to 100 mg QD, as needed, at week six. The primary endpoint of the trial is the change from baseline in systolic blood pressure versus placebo after six weeks of treatment, as measured by automated office blood pressure monitoring.
Lorundrostat is a proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of UHTN and chronic kidney disease (CKD). In a phase 2, proof-of-concept trial (target-htn) in uncontrolled or resistant hypertensive subjects, once-daily lorundrostat demonstrated clinically meaningful blood pressure reduction in both automated office blood pressure measurement and 24-hour ambulatory blood pressure monitoring.
The completion of enrollment ahead of schedule is a significant milestone for Mineralys Therapeutics, and the anticipation of topline data in mid first half of 2025 indicates progress in the development of lorundrostat. The company's management will be hosting a virtual KOL event to discuss the unmet need in hypertension, as well as a review of the ongoing pivotal clinical program for lorundrostat in hypertension.
Hypertension is a critical health issue, with sustained elevated blood pressure increasing the risk of heart disease, heart attack, and stroke. Mineralys Therapeutics aims to address this unmet need with its focus on developing medicines to target hypertension, CKD, and other diseases driven by dysregulated aldosterone. Following these announcements, the company's shares moved -0.8%, and are now trading at a price of $13.85. For the full picture, make sure to review Mineralys Therapeutics's 8-K report.
