Business
Mineralys Therapeutics Reports Third Quarter 2023 Financial Results and Provides Corporate Update
– On track to initiate planned Phase 3 pivotal Launch-HTN trial of lorundrostat to treat patients with uncontrolled or resistant hypertension in 2H 2023 – –
About this update from Mineralys Therapeutics, Inc.
[{"type":"text","content":"– On track to initiate planned Phase 3 pivotal Launch-HTN trial of lorundrostat to treat patients with uncontrolled or resistant hypertension in 2H 2023 – – Expect to initiate planned Phase 2 Explore-CKD trial of lorundrostat alone and in combination with SGLT2 inhibitor to treat hypertensive patients with chronic kidney disease (CKD) in 2H 2023 – – Conference call today at 4:30 p.m. ET – RADNOR, Pa., Nov. 07, 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 financial results for the quarter ending September 30, 2023, and provided a corporate update. “The third quarter was productive for Mineralys with ongoing progress in our clinical development of lorundrostat, the publication of our proof-of-concept study, Target-HTN, in the Journal of the American Medical Association and the addition of two new Board members. We have finalized the designs of Launch-HTN and Explore-CKD, which we believe strengthens our ability to generate data that will support patients’ real-world needs. We continue to anticipate that the Phase 3 Launch-HTN and the Phase 2 Explore-CKD trials will be initiated by the end of 2023,” stated Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. Recent Corporate and Clinical Highlights Pivotal Advance-HTN trial – The ongoing trial is evaluating 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 standardized background treatment of two or three antihypertensive medications. For subjects in the Advance-HTN trial, the treatment withdrawal component of the program has been moved forward from week 48 of treatment in the open-label extension trial to week 12 of Advance-HTN. This amendment was implemented to characterize the durability of changes in blood pressure and other pharmacodynamic measures of efficacy following the double-blind treatment period. Due to this protocol amendment and the Company’s current visibility into the enrollment curve, the Company’s expectations for topline data have been revised from the first half of 2024 to the second half of 2024. Open-Label Ext...