RADNOR, PA — Mineralys Therapeutics Inc. (Nasdaq: MLYS) reported additional clinical evidence that its experimental hypertension drug lorundrostat can lower blood pressure in patients whose condition remains uncontrolled despite multiple medications, although a separate trial found no measurable improvement in the severity of obstructive sleep apnea.
The Radnor-based biotechnology company presented the findings from its Phase 3 Launch-HTN and Phase 2 Explore-OSA trials at the American Heart Association Hypertension Scientific Sessions 2026.
In a new analysis of Launch-HTN, 46% of participants receiving 50 milligrams of lorundrostat achieved an office systolic blood pressure below 130 millimeters of mercury after 12 weeks, meeting the target recommended by American Heart Association and American College of Cardiology guidelines.
Approximately 70% of lorundrostat-treated participants achieved a systolic blood pressure reduction of at least 10 mmHg, according to the company.
The findings provide additional evidence of the drug’s blood pressure-lowering activity in patients with uncontrolled or treatment-resistant hypertension, a population that often requires multiple medications to manage cardiovascular risk.
Launch-HTN enrolled adults whose blood pressure remained uncontrolled despite treatment with two to five antihypertensive medications.
The global, randomized, double-blind, placebo-controlled Phase 3 trial evaluated lorundrostat at 50 milligrams daily, a 50-milligram regimen allowing an increase to 100 milligrams after six weeks, and placebo.
The trial’s primary endpoint measured the change in systolic blood pressure after six weeks compared with placebo. The newly presented analysis examined treatment outcomes at 12 weeks.
“In this new analysis, nearly half of the lorundrostat-treated participants achieved a guideline-recommended SBP below 130 mmHg,” said Manish Saxena, the study’s principal investigator and deputy clinical co-director of Queen Mary University of London’s William Harvey Heart Centre.
Saxena said a sustained reduction of at least 10 mmHg has been associated with a 20% reduction in cardiovascular event risk. That relationship reflects broader clinical evidence rather than a demonstrated reduction in cardiovascular events among Launch-HTN participants.
Separately, Mineralys reported final results from Explore-OSA, a Phase 2 trial evaluating lorundrostat in overweight or obese adults with moderate-to-severe obstructive sleep apnea and hypertension.
Participants receiving 50 milligrams of lorundrostat once daily in the evening experienced an average reduction of 11.1 mmHg in morning systolic blood pressure after four weeks, compared with a 1.0 mmHg reduction during placebo treatment.
The blood pressure reduction during lorundrostat treatment was statistically significant, with a reported p-value below 0.0001. The reduction during placebo treatment was not statistically significant.
However, the drug produced no measurable change in the apnea-hypopnea index, which measures the frequency of breathing interruptions during sleep.
That distinction is important because improvement in the apnea-hypopnea index was the trial’s primary efficacy endpoint. The findings therefore support lorundrostat’s potential role in blood pressure management among patients with sleep apnea, rather than demonstrating that it treats the underlying sleep disorder.
Explore-OSA used a randomized, double-blind, placebo-controlled crossover design in which participants received lorundrostat and placebo during separate treatment periods.
Researchers monitored blood pressure during overnight sleep studies and evaluated additional measures of cardiovascular and sleep health.
Mineralys reported that lorundrostat was generally well tolerated in Explore-OSA, with no significant safety events identified, including hyperkalemia, a condition involving elevated potassium levels in the blood.
“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, Mineralys’ chief medical officer.
The results are relevant to a patient population in which hypertension and obstructive sleep apnea frequently overlap.
According to figures cited by Mineralys, obstructive sleep apnea affects an estimated 30% to 50% of adults with hypertension and approximately 70% to 80% of those with resistant hypertension.
The condition involves repeated obstruction of the upper airway during sleep and is associated with elevated nighttime blood pressure and increased cardiovascular risk.
Lorundrostat is an investigational oral aldosterone synthase inhibitor designed to reduce production of aldosterone, a hormone involved in regulating blood pressure and fluid balance.
The drug targets CYP11B2, the enzyme responsible for aldosterone production. Mineralys is developing the treatment for uncontrolled and resistant hypertension, as well as related conditions involving abnormal aldosterone activity.
The company said it has completed six late-stage clinical trials of lorundrostat, including its Phase 3 Launch-HTN and Phase 2 Advance-HTN studies.
Those two trials form part of the company’s registrational development program, with Mineralys reporting sustained blood pressure reductions and generally favorable tolerability across the studies.
The latest analyses strengthen the evidence supporting lorundrostat’s blood pressure-lowering effects while underscoring a limitation in its potential application to obstructive sleep apnea: reducing hypertension does not necessarily improve the breathing disturbances that define the disorder.
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