Mineralys Therapeutics announced on June 17, 2025, positive topline data from its Phase 2 Explore-CKD trial, evaluating lorundrostat in subjects with hypertension and comorbid chronic kidney disease (CKD). The crossover trial met its primary endpoint, demonstrating clinically meaningful reductions in both systolic automated office blood pressure (AOBP) and urine albumin-to-creatinine ratio (UACR).
Lorundrostat 25 mg once daily achieved a 9.3 mmHg reduction in systolic blood pressure and a 7.5 mmHg placebo-adjusted reduction (p=0.0024) at four weeks. Additionally, a clinically meaningful 31% reduction in UACR (p<0.0001) was observed, indicating potential kidney protection.
The trial also demonstrated a favorable safety and tolerability profile, with a 5% incidence of confirmed hyperkalemia (> 6.0 mmol/L). These results, combined with previous pivotal trial successes, comprise a core package for the company's planned NDA submission, expanding lorundrostat's potential beyond hypertension.
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