Mineralys Therapeutics’ lorundrostat targets nocturnal hypertension linked to sleep apnea.
Mineralys Therapeutics Inc has completed enrollment in its phase 2 EXPLORE-OSA trial of lorundrostat in participants with moderate-to-severe obstructive sleep apnea (OSA) and hypertension.
“Obstructive sleep apnea and high blood pressure are biologically linked, with blood pressure rising during upper airway obstruction during sleep. In dosing lorundrostat at bedtime, we believe it will suppress the majority of aldosterone produced during sleep while maintaining 24-hour blood pressure control,” says David Rodman, MD, chief medical officer of Mineralys Therapeutics, in a release. “Episodes of nocturnal hypertension are underdiagnosed and lack an effective treatment.”
The EXPLORE-OSA proof-of-concept trial is a randomized, double-blind, placebo-controlled, crossover trial designed to evaluate the efficacy, safety, and tolerability of lorundrostat in overweight or obese adults with moderate-to-severe OSA and hypertension. Participants will receive 50 mg of oral, once daily lorundrostat and placebo in sequential treatment periods, with continuous monitoring of blood pressure during overnight polysomnography.
The primary efficacy endpoint is absolute change from baseline in apnea-hypopnea index (AHI) after four weeks of active treatment compared to placebo. Key secondary endpoints include changes in blood pressure, nighttime blood pressure, and additional sleep and cardiovascular health measures.
Now that participant enrollment is complete, the company anticipates analyzing and reporting top-line results of the EXPLORE-OSA trial in the first quarter of 2026.
If the trial is successful, the company believes these data will complement the previously announced positive topline data from its EXPLORE-CKD trial. Demonstrating positive results in these two patient populations would continue to expand the opportunity for lorundrostat in treating hypertension patients with these comorbidities.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities, such as chronic kidney disease, OSA, and other diseases driven by dysregulated aldosterone.
