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Mineralys Therapeutics Announces First Subject Dosed in Launch-HTN, the Second Pivotal Trial of Lorundrostat for the Treatment of Hypertension
– Topline data from confirmatory Launch-HTN trial expected in 2H 2025 – – Topline data from ongoing Advance-HTN pivotal trial expected in 2H 2024 – RADNOR,
About this update from Mineralys Therapeutics, Inc.
[{"type":"text","content":"– Topline data from confirmatory Launch-HTN trial expected in 2H 2025 – – Topline data from ongoing Advance-HTN pivotal trial expected in 2H 2024 – RADNOR, Pa., Dec. 21, 2023 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases driven by abnormally elevated aldosterone, today announced that the first subject has been dosed in the Launch-HTN (NCT06153693) pivotal trial to evaluate the safety and efficacy of lorundrostat for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), when used as an add-on therapy to prescribed background treatment. “Initiating this second pivotal trial demonstrates the continued progress we’re making towards introducing a targeted approach to care in hypertension by identifying and profiling potential responders to lorundrostat,” stated Jon Congleton, Chief Executive Officer of Mineralys. “In parallel with our development of lorundrostat, we have been pleased to see accumulating evidence generated by the medical community highlighting aldosterone as a key driver in cardiorenal disease.” Launch-HTN is the second of two clinical trials under the planned pivotal program to evaluate the safety and efficacy of lorundrostat when added to subjects’ existing background hypertension treatment. This trial is designed to model real world treatment of uHTN and rHTN in the primary care setting. Launch-HTN is a global, randomized, double-blinded, placebo-controlled Phase 3 trial that is designed to enroll up to approximately 1,000 eligible adult participants who are failing to achieve their blood pressure goal on two to five background antihypertensive medications. Eligible subjects will be 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 change from baseline in systolic blood pressure versus placebo after 12 weeks of treatment, as measured by automated office blood pressure monitoring. Previously, in May 2023, the Company announced the first subject dosed in the first pivotal trial, Advance-HTN. The Company expects to announce topline data from the Advance-HTN trial in the second half...