Business
Mineralys Therapeutics Reports Second Quarter 2024 Financial Results and Provides Corporate Update
– Advance-HTN trial is approximately 90% enrolled; trial is anticipated to deliver topline data in Q1 2025 – – Enrollment ahead of schedule in Phase 3 pivotal
About this update from Mineralys Therapeutics, Inc.
[{"type":"text","content":"– Advance-HTN trial is approximately 90% enrolled; trial is anticipated to deliver topline data in Q1 2025 – – Enrollment ahead of schedule in Phase 3 pivotal Launch-HTN trial and on track to deliver topline data as anticipated in 2H 2025 – – Ongoing Explore-CKD Phase 2 trial is ramping up enrollment under the amended protocol and is anticipated to deliver topline data in 1H 2025 – – Conference call today at 4:30 p.m. ET – RADNOR, Pa., Aug. 13, 2024 (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 dysregulated aldosterone, today announced financial results for the second quarter ending June 30, 2024, and provided a corporate update. “During the first half of 2024, we continued to make progress executing our pivotal development program for lorundrostat to treat uHTN or rHTN. Considering the current pace of enrollment in the Advance-HTN trial, which is approximately 90 percent enrolled, we anticipate announcing topline data during the first quarter of 2025. To our knowledge, this will be one of the most rigorous trials ever completed for an aldosterone targeted therapy,” stated Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. “In addition, we have significantly ramped up enrollment in our pivotal Launch-HTN trial, which is well ahead of schedule compared to our enrollment projections.” Recent Clinical Highlights and Upcoming Milestones Pivotal Advance-HTN Trial – Based on the anticipated timing of full enrollment, the Company is guiding to announce top-line data in the first quarter of 2025. The trial is evaluating the efficacy and safety of lorundrostat for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), when used as an add-on therapy to a standardized background treatment of two or three antihypertensive medications. In August 2024, the Company met with the FDA and aligned on maintaining the primary endpoint for the Advance-HTN trial as the change in 24-hour ambulatory systolic blood pressure (BP) at week twelve from baseline for active cohorts versus placebo.Pivotal Launch-HTN Phase 3 Trial – Enrollment in the Launch-HTN Phase 3 trial is ahead of schedule, with topline data on track to be available in the ...