Mineralys Therapeutics Launches Phase 2 Trial of Lorundrostat for Sleep Apnea in Hypertensive Patients

Mineralys Therapeutics has received approval from the U.S. FDA to proceed with a Phase 2 clinical trial investigating lorundrostat for treating moderate-to-severe obstructive sleep apnea (OSA) and hypertension. The trial is expected to begin in early 2025. Lorundrostat marks Mineralys' third targeted application, potentially broadening its impact in diseases influenced by aldosterone dysregulation.

Obstructive sleep apnea is a widespread condition, affecting an estimated 54 million Americans, with a significant portion also suffering from hypertension. This overlap is alarming because both OSA and hypertension are associated with increased risk of severe health issues, including cardiovascular diseases. Mineralys aims to address these interconnected health problems with lorundrostat, a medication designed to inhibit aldosterone production, potentially mitigating the factors exacerbating both conditions.

Jon Congleton, CEO of Mineralys Therapeutics, emphasized the strategic alignment of this trial with the company’s broader goals. He highlighted how the characteristics of lorundrostat could offer dual benefits: alleviating symptoms of sleep apnea and controlling nocturnal hypertension, which is pivotal in reducing cardiovascular risks. Dr. Reena Mehra, a newly appointed member of Mineralys’ Scientific Advisory Board, noted the extensive pressures faced by patients with OSA, particularly in managing hypertension, and expressed optimism about the study's innovative approach, which incorporates advanced technology and expert collaboration.

The Phase 2 trial will be a placebo-controlled, crossover study involving around 40 adult participants who have a BMI of at least 27 kg/m² and are diagnosed with moderate-to-severe OSA. Conducted across approximately 40 sites, the study aims to assess the safety and effectiveness of a 50mg dose of lorundrostat, administered daily in the evening. The primary goal is to measure changes in apnea-hypopnea episodes, while secondary objectives include evaluating nighttime blood pressure variations using continuous monitoring during sleep studies, excluding the use of CPAP.

Mineralys is confident that its current financial resources will be sufficient to support its clinical operations through early 2026. Moreover, the company is dedicated to exploring the broader implications of OSA, a condition marked by frequent interruptions to breathing during sleep. OSA not only affects nearly a billion people worldwide but also remains largely undiagnosed in many cases. In the United States, undiagnosed OSA leads to significant economic burdens, evident in costs associated with related health complications, accidents, and diminished productivity. Notably, the condition is highly prevalent among individuals with hypertension, especially those with resistant hypertension, underscoring the urgent need for effective treatments.

Lorundrostat is a proprietary oral aldosterone synthase inhibitor developed by Mineralys, targeting conditions such as uncontrolled and resistant hypertension, chronic kidney disease, and now OSA. This drug specifically inhibits the enzyme CYP11B2, crucial for aldosterone production, and has demonstrated substantial reductions in plasma aldosterone levels in hypertensive patients. Previous trials have shown promising results in lowering blood pressure, though some side effects, such as increased serum potassium and reduced kidney function, have been observed.

Mineralys Therapeutics is a clinical-stage biopharmaceutical company committed to developing medications for conditions driven by aldosterone dysregulation. Based in Radnor, Pennsylvania, and founded by Catalys Pacific, Mineralys continues to explore the potential of lorundrostat in addressing complex cardiorenal disorders.