Core Insights - Mineralys Therapeutics announced positive topline data from its Phase 2 Explore-CKD trial, demonstrating the efficacy and safety of lorundrostat in treating hypertension and chronic kidney disease (CKD) [1][2][3] Efficacy, Safety and Tolerability Results - The Explore-CKD trial was a randomized, double-blind, placebo-controlled crossover trial involving 59 subjects, focusing on the efficacy of 25 mg lorundrostat in reducing systolic blood pressure (BP) and urine albumin-to-creatinine ratio (UACR) [4][13] - Lorundrostat achieved a 9.3 mmHg reduction in systolic BP and a 31% reduction in UACR, both statistically significant [7][5] - The trial showed a favorable safety profile, with treatment-emergent adverse events (TEAEs) leading to discontinuation in 3% of subjects during lorundrostat treatment [8][9] Clinical Significance - The trial results support the potential of lorundrostat as a treatment option for patients with hypertension and comorbid CKD, addressing the underlying mechanisms of these conditions [10][11] - The findings contribute to a growing body of evidence validating aldosterone synthase inhibitors in managing hypertension and CKD [10][18] Future Development - Mineralys plans to submit a New Drug Application (NDA) based on the successful outcomes of the Explore-CKD trial, along with previous pivotal trials [2][18] - Ongoing studies, including the Transform-HTN extension trial and the Explore-OSA trial, aim to further evaluate the long-term efficacy and safety of lorundrostat [11][19]