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Mineralys Therapeutics Completes Enrollment in Explore-CKD Phase 2 Trial of Lorundrostat for the Treatment of Hypertension in Subjects with Stage 2 to 3b CKD and Albuminuria
Continues to anticipate announcing topline data from Explore-CKD trial in Q2 2025 RADNOR, Pa., Feb. 04, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc.
About this update from Mineralys Therapeutics, Inc.
[{"type":"text","content":"Continues to anticipate announcing topline data from Explore-CKD trial in Q2 2025\nRADNOR, Pa., Feb. 04, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced that it has completed enrollment in the Explore-CKD Phase 2 trial evaluating the efficacy and safety of lorundrostat for the treatment of hypertension in subjects with CKD and albuminuria, despite receiving stable treatment with an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB) and an SGLT2 inhibitor. “We are pleased to have completed enrollment in Explore-CKD and be on track to share topline data in the second quarter of 2025. This is our third trial to recently complete enrollment and we are grateful to all of the study participants, investigators, and our staff who made this possible,” stated David Rodman, MD, Chief Medical Officer of Mineralys Therapeutics. “In concert with our Target-HTN, Advance-HTN and recently announced Explore-OSA trials, Explore-CKD expands the spectrum of high-risk patients with poorly controlled hypertension who may benefit from this novel treatment modality. Poorly controlled hypertension, and hypertensive nephropathy, are a leading cause of renal failure in the United States and a strong predictor of major adverse cardiovascular events and premature death.” The Explore-CKD trial (NCT06150924) is a randomized, double-blind, placebo controlled, two-period, two-sequence (2x2) crossover trial. This proof-of-concept trial is designed to evaluate blood pressure reduction and safety of 25 mg once daily (QD) lorundrostat added to RAAS inhibition and an SGLT2 inhibitor for the treatment of hypertension in subjects with Stage 2 to 3b CKD and albuminuria. The primary efficacy endpoint of the trial is change from baseline in systolic blood pressure at week four in the active versus placebo treatment period. An exploratory endpoint will be to evaluate change from baseline in urine albumin-to-creatinine ratio at week four in the active versus placebo treatment period. About CKD CKD, which is characterized by the gradual loss of kidney function, is estimated to affect more th...