Mineralys presents new lorundrostat data at AHA Hypertension 2026
Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and aldosterone-related outcomes in comorbid conditions such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, announced today the presentation of a new analysis from its pivotal Phase 3 Launch-HTN trial, showing that at Week 12, 46% of lorundrostat-treated participants achieved the AHA/ACC Guideline recommended office systolic blood pressure (SBP) target of <130 mmHg. These results were presented at the American Heart Association Hypertension Scientific Sessions 2026 (AHA-HTN), taking place October 7-11 in Arlington, VA.
“Hypertension remains the most important risk factor for cardiovascular diseases, as blood pressure control rates remain poor. Participants in Launch-HTN had uncontrolled or treatment-resistant hypertension, despite being treated with two to five antihypertensive therapies. In this new analysis, nearly half of the lorundrostat-treated participants achieved a guideline-recommended SBP below 130 mmHg,” said Manish Saxena, MBBS, principal investigator on the study and Deputy Clinical Co-Director of Queen Mary University of London’s William Harvey Heart Centre, and Hypertension Specialist at Barts Health NHS Trust. “In addition, 70% of lorundrostat-treated participants achieved an SBP reduction of 10 mmHg or more, a level that, if sustained in the long term, is associated with a 20% reduction in the risk of a cardiovascular event. The results of the analysis reinforce the potential of lorundrostat to deliver clinically meaningful reductions in blood pressure in patients with difficult-to-treat hypertension.”
In a separate oral presentation, the final results of the Phase 2 Explore-OSA trial of lorundrostat in overweight or obese adults with moderate-to-severe OSA and hypertension were featured. Participants receiving lorundrostat 50 mg once daily in the evening achieved clinically meaningful reductions in morning SBP of 11.1 mmHg at Week 4 (p<0.0001), compared with 1.0 mmHg reduction for participants receiving placebo (p=NS), although no measurable change in apnea-hypopnea indices were observed with lorundrostat. In the study, lorundrostat exhibited a favorable safety and tolerability profile, and there was no evidence of significant safety events, including hyperkalemia (high serum potassium).
“The observed reductions in morning blood pressure in Explore-OSA were consistent with the reductions in our other pivotal trials of lorundrostat in participants with uncontrolled or treatment-resistant hypertension,” said Terry Ferguson, MD, Chief Medical Officer of Mineralys Therapeutics. “Results across lorundrostat trials to date demonstrate a compelling potential for lorundrostat to help a significant proportion of patients with uncontrolled or treatment-resistant hypertension, including those who also have CKD or OSA, reduce their systolic blood pressure to a level that may also reduce their risk of cardiovascular events.”
– New analyses from the pivotal Launch-HTN trial showed that 46% of participants with difficult-to-treat hypertension receiving lorundrostat 50 mg achieved the AHA/ACC Guideline systolic blood pressure target of <130 mmHg at 12 weeks, with more than two-thirds achieving ≥10 mmHg systolic blood pressure reduction –
– In the Explore-OSA trial in participants with obstructive sleep apnea, lorundrostat 50 mg taken once daily in the evening achieved clinically meaningful reductions in morning systolic blood pressure with no measurable change in apnea-hypopnea indices –
About Launch-HTN
The Launch-HTN trial (NCT06153693) was a global, randomized, double-blind, placebo-controlled Phase 3 clinical trial of adults whose blood pressure remained uncontrolled despite being on two to five antihypertensive medications. Participants were assigned to one of three groups: lorundrostat 50 mg once daily; lorundrostat 50 mg once daily with the option to increase to 100 mg at week six based on prespecified criteria; or placebo. The primary endpoint was change from baseline in systolic blood pressure at six weeks versus placebo, measured by automated office blood pressure monitoring.
About Explore-OSA
The Explore-OSA trial (NCT06785454) was a randomized, double-blind, placebo-controlled, crossover Phase 2 clinical trial. This proof-of-concept trial was designed to evaluate the efficacy, safety and tolerability of lorundrostat in overweight or obese adults with moderate-to-severe OSA and hypertension. Participants in Explore-OSA received lorundrostat 50 mg once daily and placebo in sequential treatment periods, with continuous monitoring of blood pressure during overnight polysomnography. The primary efficacy endpoint of the trial was absolute change from baseline in apnea-hypopnea index after four weeks of active treatment compared to placebo. The first secondary endpoint was automated office blood pressure, and additional endpoints were nighttime blood pressure and sleep and cardiovascular health measures.
RADNOR, Pa., Oct. 09, 2026 (GLOBE NEWSWIRE)
