Mineralys Therapeutics, Inc. (NASDAQ: MLYS) has announced the clearance of its investigational new drug (IND) application by the U.S. Food and Drug Administration (FDA) for a phase 2 clinical trial to evaluate the effect of lorundrostat in the treatment of subjects with moderate-to-severe obstructive sleep apnea (OSA) and hypertension.
The phase 2 clinical trial is set to evaluate the safety and efficacy of lorundrostat 50mg taken once daily in the evening in approximately 40 subjects with moderate-to-severe OSA. The trial will be a placebo-controlled, crossover study conducted across approximately 40 sites. The trial aims to validate the hypothesis that lorundrostat both alleviates the severity of upper airway obstruction and reduces nocturnal hypertension.
Key objectives of the trial include the assessment of the absolute change in the frequency of apnea-hypopnea episodes as the primary outcome measure, as well as quantifying blood pressure throughout the night using continuous blood pressure monitoring during a standard sleep study without the benefit of CPAP as the key secondary objective.
In addition, standard patient reported outcomes specific to OSA will also be assessed. The company anticipates initiating the trial in the first quarter of 2025 and expects that its current cash, cash equivalents, and investments will be sufficient to fund its planned clinical trials and support its corporate operations through the first quarter of 2026.
Furthermore, the company announced that lorundrostat represents its third precision, targeted indication, further expanding its market potential in aldosterone-driven diseases. According to the company, lorundrostat has 374-fold selectivity for aldosterone-synthase inhibition versus cortisol-synthase inhibition in vitro, an observed half-life of 10-12 hours, and demonstrated approximately a 70% reduction in plasma aldosterone concentration in hypertensive subjects.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), OSA, and other diseases driven by dysregulated aldosterone. Their initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor that the company is developing for cardiorenal conditions affected by dysregulated aldosterone, including hypertension, CKD, and OSA. Today the company's shares have moved -6.2% to a price of $12.18. For the full picture, make sure to review Mineralys Therapeutics's 8-K report.
