RADNOR, PA — Mineralys Therapeutics, Inc. (Nasdaq: MLYS) will present five studies of lorundrostat at the American Heart Association’s Hypertension Scientific Sessions this week, extending its clinical work beyond uncontrolled and resistant hypertension into obstructive sleep apnea and broader cardiorenal disease.
The presentations, scheduled for Oct. 8 and 9 in Arlington, Virginia, include an oral presentation from the Phase 2 Explore-OSA trial and analyses tied to the Phase 3 Launch-HTN program.
Lorundrostat is an investigational oral drug designed to inhibit aldosterone synthase, reducing production of aldosterone, a hormone implicated in some cases of difficult-to-control hypertension.
The Explore-OSA presentation will examine efficacy and safety in overweight or obese adults with moderate-to-severe obstructive sleep apnea and hypertension.
The randomized, double-blind crossover trial compared lorundrostat 50 mg once daily with placebo. Its primary efficacy endpoint measured the change in apnea-hypopnea index after four weeks, with blood pressure and other sleep and cardiovascular measures among the additional endpoints.
Reena Mehra, a professor of medicine and head of pulmonary, critical care and sleep medicine at the University of Washington, will present the Explore-OSA findings Oct. 8.
Mineralys will also present a blood-pressure responder analysis from Launch-HTN, its global Phase 3 trial in adults whose hypertension remained uncontrolled while taking two to five medications.
Launch-HTN compared placebo with lorundrostat at 50 mg daily and a separate regimen allowing an increase from 50 mg to 100 mg at week six under prespecified criteria. The primary endpoint measured the change in systolic blood pressure at six weeks.
Other presentations will examine lorundrostat’s effects on cardiorenal injury in an animal model, real-world use of spironolactone in patients with hypertension and adherence to mineralocorticoid receptor antagonists among patients with uncontrolled or treatment-resistant hypertension.
The additional research broadens Mineralys’ effort to establish aldosterone as a therapeutic target across hypertension and related conditions, including chronic kidney disease and obstructive sleep apnea.
Lorundrostat inhibits CYP11B2, the enzyme responsible for aldosterone production. The drug has demonstrated a 40% to 70% reduction in plasma aldosterone concentrations among participants with hypertension and has an observed half-life of 10 to 12 hours.
Mineralys has completed six late-stage clinical trials of lorundrostat. Its development program includes the pivotal Phase 3 Launch-HTN trial and Phase 2 Advance-HTN trial.
The company estimates that dysregulated aldosterone contributes to hypertension in about 30% of patients. Fewer than half of people with hypertension reach their blood-pressure goals with existing medications, according to information provided by Mineralys.
Hypertension was listed as a primary or contributing cause in more than 685,000 U.S. deaths in 2022. The condition and related health problems carried an estimated annual U.S. economic burden of about $219 billion in 2019.
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