Mineralys Therapeutics Announces Publication of Phase 2 Explore-CKD Trial Results for Lorundrostat in Kidney International
– Explore-CKD met its primary endpoint; lorundrostat 25 mg once daily added to an SGLT2 inhibitor achieved a statistically significant reduction in systolic blood pressure at four weeks – – New hormonal and urinary protein data show a 41.5% reduction in serum aldosterone with additional significant reductions in albuminuria and proteinuria – RADNOR, Pa., Oct. 28, 2026 (GLOBE NEWSWIRE) — Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and aldosterone-related adverse outcomes in comorbid conditions such as chronic kidney disease (CKD), obstructive sleep apnea and other diseases driven by dysregulated aldosterone, today announced that the full results from the Phase 2 Explore-CKD trial of lorundrostat in participants with uncontrolled hypertension, CKD and albuminuria have been published in Kidney International and are available online. The Explore-CKD trial evaluated the efficacy and safety of lorundrostat, an aldosterone synthase inhibitor, added to guideline-directed background therapy in 59 participants with uncontrolled hypertension, stage 1 to 3b CKD and albuminuria (albumin loss in the urine), an early manifestation of kidney damage. “Chronic kidney disease and hypertension are pathologically linked, and approximately 76% of patients with both CKD and hypertension have uncontrolled blood pressure despite treatment with multiple antihypertensive medications,” said Matthew R. Weir, MD, Director of the Division of Nephrology at the University of Maryland Medical Center, Professor of Medicine at the University of Maryland School of Medicine, lead author of the publication and scientific consultant for Mineralys. “The Explore-CKD results demonstrate that lorundrostat may help CKD patients reduce otherwise uncontrolled high blood pressure and potentially improve their kidney function.” “With this publication we have additional peer-reviewed evidence demonstrating the potential benefits of lorundrostat for people living with uncontrolled or resistant hypertension and CKD, a population that is especially difficult to treat,” said Terry Ferguson, MD, Chief Medical Officer of Mineralys Therapeutics. “There were consistent reductions in urinary protein loss, along with the expected reductions in serum aldosterone levels. Further evaluation of lorundrostat as a therapeutic approach for lowering blood pressure and reducing albuminuria in participants with CKD will follow shortly, with longer-term data from Explore-CKD participants enrolled in the Transform-HTN open-label extension study.” Key Findings from Explore-CKD Explore-CKD randomized 59 participants at 42 sites in the United States. Participants had a mean age of 64.6 years and a mean body mass index of 33.1 kg/m2, and 76% had type 2 diabetes. Of the participants, 30.5% were female, 16.9% were Black or African American and 42.4% were Hispanic or Latino. At baseline, mean automated office systolic blood pressure (AOSBP) was 149 mmHg, UACR (urinary albumin-to-creatinine ratio, an indicator of kidney protein loss) was 516.8 mg/g and mean estimated glomerular filtration rate (eGFR) was 43 mL/min/1.73m2 based on cystatin C. Overall, 64.4% of participants were taking three or more antihypertensive medications. The primary efficacy endpoint was the change from baseline in systolic blood pressure at week four in the active versus placebo treatment period. At week four, lorundrostat 25 mg once daily achieved a 9.3 mmHg reduction in AOSBP, compared with a 1.8 mmHg reduction for placebo, yielding a placebo-adjusted reduction of 7.5 mmHg (95% CI, -12.3 to -2.7; p=0.0024). Automated office diastolic blood pressure was reduced by 3.9 mmHg with lorundrostat and 1.4 mm Hg with placebo. Lorundrostat also reduced UACR by 30.5% from baseline and by 25.6% placebo-adjusted (p=0.0015) at week four. The placebo-adjusted reductions were also significant for 24-hour UACR (26.1%; p
