Data for Lorundrostat in Chronic Kidney Disease and Hypertension Presented at American Society of Nephrology (ASN) Kidney Week 2025

– Late-breaking presentation of Explore-CKD trial at ASN Kidney Week –

– Pivotal Phase 3 Launch-HTN trial featured in the “Best of JAMA and NEJM” session -

RADNOR, Pa., Nov. 07, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company developing therapies to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced that clinical data for lorundrostat were presented at the American Society of Nephrology (ASN) Kidney Week 2025. Findings included a late-breaking oral presentation of the Phase 2 Explore-CKD trial and recognition of the pivotal Phase 3 Launch-HTN trial in the “Best of the Journal of the American Medical Association (JAMA) and the New England Journal of Medicine (NEJM)” session.

“The presentations at ASN Kidney Week demonstrated the breadth and strength of lorundrostat’s clinical program. As previously announced, the compelling results from multiple trials in this program have positioned us well for the planned filing of a New Drug Application to the FDA in the fourth quarter of 2025 or the first quarter of 2026,” said Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. “In Explore-CKD, lorundrostat reduced both blood pressure and albuminuria in participants with chronic kidney disease. We are pleased that the significant and consistent blood pressure reduction previously reported with lorundrostat in the Launch-HTN trial was selected for the “Best of JAMA” presentation at ASN’s Kidney Week 2025. With consistent benefits across blood pressure and kidney outcomes, lorundrostat is uniquely positioned to address the growing burden of cardio-renal-metabolic disease.”

Late-breaking presentation on the Explore-CKD trial (NCT06150924) of lorundrostat 25 mg once daily added to standard-of-care therapy, including sodium-glucose cotransporter-2 (SGLT2) inhibitors, demonstrated statistically significant and clinically meaningful reductions in blood pressure and albuminuria in participants with uncontrolled hypertension and CKD at four weeks of treatment. The trial met its primary endpoint, showing a reduction of 9.3 mmHg in automated office systolic blood pressure (AOSBP), and a placebo adjusted reduction of 7.5 mmHg (p-value=0.0024) at week four. Lorundrostat also achieved a reduction in spot urinary albumin-to-creatinine ratio (UACR), a marker of kidney protection, of 25.6% placebo-adjusted reduction (p=0.0015) at week four.

In Explore-CKD, lorundrostat demonstrated a favorable safety and tolerability profile. Serious adverse events occurred in two participants (3%) during lorundrostat treatment and none on placebo. Discontinuations due to treatment-emergent adverse events occurred in two participants (3%) during the lorundrostat treatment period and one participant (2%) during the placebo treatment period.

“These results are important because they show that lorundrostat, when added to standard-of-care therapy, reduced both blood pressure and proteinuria in patients with hypertension and chronic kidney disease,” said Dr. Matthew Weir, Director of the Division of Nephrology at the University of Maryland Medical Center, Professor of Medicine at the University of Maryland School of Medicine, and a scientific consultant to Mineralys Therapeutics. “The parallel reductions in systolic blood pressure and albuminuria underscore the potential of lorundrostat to improve cardio-renal outcomes in this high-risk population.”

In addition, the pivotal Phase 3 Launch-HTN trial was recognized in ASN’s “Best of JAMA and NEJM” session following publication earlier this year in JAMA. Lorundrostat demonstrated a statistically significant 16.9 mmHg absolute reduction in systolic blood pressure (SBP) at week 6 (9.1 mmHg placebo-adjusted, p