RADNOR, PA — Mineralys Therapeutics, Inc. (Nasdaq: MLYS) has announced the completion of enrollment for its Explore-CKD Phase 2 trial. The study is evaluating the efficacy and safety of lorundrostat, a novel aldosterone synthase inhibitor, in treating hypertension in patients with chronic kidney disease (CKD) and albuminuria.
The randomized, double-blind, placebo-controlled trial involves a two-period, two-sequence crossover design to assess blood pressure reduction with 25 mg of lorundrostat added to RAAS inhibitors and SGLT2 inhibitors. The trial’s primary endpoint is the change in systolic blood pressure from baseline after four weeks of treatment, while exploratory endpoints include assessing changes in urinary albumin-to-creatinine ratio at the same period.
“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,” said David Rodman, MD, Chief Medical Officer of Mineralys Therapeutics. “Explore-CKD expands the spectrum of high-risk patients with poorly controlled hypertension who may benefit from this novel treatment modality.”
CKD and hypertension remain significant global health challenges. CKD affects more than 10% of the global population and 15% of U.S. adults, according to estimates. Diabetes and hypertension together account for about two-thirds of CKD cases. Sustained hypertension is a leading contributor to heart disease, stroke, and kidney failure worldwide, with an economic burden of approximately $130 billion per year in the U.S. alone.
Lorundrostat offers a targeted approach to addressing hypertension by selectively reducing aldosterone levels through aldosterone synthase inhibition. With demonstrated efficacy in earlier studies, the drug has shown potential for clinically meaningful blood pressure reductions in challenging, uncontrolled hypertensive populations.
The company’s Explore-CKD trial builds on its broader development initiatives, including other trials such as Target-HTN, Advance-HTN, and Explore-OSA. The topline data expected in mid-2025 could highlight lorundrostat’s role in addressing unmet needs for patients with hypertension and CKD, offering hope for improved health outcomes and quality of life.
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