Mineralys Therapeutics Completes Enrollment in Phase 2 EXPLORE-OSA Trial of Lorundrostat in Obstructive Sleep Apnea and Hypertension

Core Insights - Mineralys Therapeutics has completed enrollment in its Phase 2 EXPLORE-OSA trial for lorundrostat, targeting patients with moderate-to-severe obstructive sleep apnea (OSA) and hypertension, with top-line results expected in Q1 2026 [1][2] - The trial aims to address the significant unmet need for effective treatments for patients suffering from OSA and hypertension, as current options are limited and often ineffective [2][3] - Lorundrostat is a selective aldosterone synthase inhibitor designed to reduce aldosterone levels, which are linked to hypertension and related comorbidities [8][9] Company Overview - Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for hypertension, chronic kidney disease (CKD), and OSA, driven by dysregulated aldosterone [9] - The company is based in Radnor, Pennsylvania, and was founded by Catalys Pacific [9] Trial Details - The EXPLORE-OSA trial is a randomized, Phase 2 double-blind, placebo-controlled, crossover study evaluating the efficacy, safety, and tolerability of lorundrostat in overweight or obese adults with moderate-to-severe OSA and hypertension [3] - Participants will receive 50 mg of lorundrostat or placebo, with the primary efficacy endpoint being the change in apnea-hypopnea index (AHI) after four weeks of treatment [3] Disease Context - OSA affects nearly one billion people globally, with 425 million cases classified as moderate-to-severe, and around 80% of adults with OSA remain undiagnosed [4] - Hypertension is a major health issue, contributing to over 685,000 deaths in the U.S. in 2022, with an estimated economic burden of $219 billion in 2019 [6] Market Opportunity - Between 30-50% of adults with hypertension have OSA, and this figure rises to 70-80% in those with resistant hypertension (rHTN) [5] - There is a significant opportunity for lorundrostat to address the needs of patients with both hypertension and OSA, particularly given the limitations of current treatment options [2][5]