RADNOR, PA — Mineralys Therapeutics, Inc. (Nasdaq: MLYS) has announced detailed results from its pivotal Phase 3 Launch-HTN trial, showcasing the efficacy and safety of lorundrostat for patients with uncontrolled hypertension (uHTN) or resistant hypertension (rHTN). The study demonstrated significant and sustained reductions in blood pressure among over 1,000 participants who were already on two to five antihypertensive medications.
Lorundrostat, administered at 50 mg once daily, delivered a 16.9 mmHg reduction in systolic blood pressure at six weeks (-9.1 mmHg placebo adjusted) and a 19 mmHg reduction at 12 weeks (-11.7 mmHg placebo adjusted). The trial also confirmed a favorable safety profile, with minimal treatment-related side effects.
“The detailed results from Launch-HTN, designed to reflect treatment in the real-world setting, mark a pivotal milestone in our mission to deliver the first targeted aldosterone synthase inhibitor to the millions of people suffering from uncontrolled or resistant hypertension,” said Jon Congleton, CEO of Mineralys Therapeutics.
Dr. Manish Saxena, a hypertension specialist at Queen Mary University of London, emphasized the long-term benefits demonstrated by lorundrostat. “The clinically meaningful and sustained reductions in systolic blood pressure observed with lorundrostat are especially important, as long-term control is key to lowering the risk of serious cardiovascular, renal, and metabolic complications,” he noted.
The Launch-HTN trial, one of the largest hypertension trials involving an aldosterone synthase inhibitor, adopted real-world clinical conditions by allowing participants to remain on existing medications. The trial addressed the unmet need among millions of patients whose hypertension is poorly managed despite current therapies.
Key safety findings showed low incidences of treatment-related adverse effects. Lorundrostat-treated participants experienced minimal disruptions in serum electrolyte levels, and severe adverse events (SAEs) were rare, with only one treatment-related SAE recorded.
Hypertension remains a critical public health challenge, contributing to over 685,000 deaths in the U.S. in 2022 alone. Lorundrostat provides a new therapeutic avenue by targeting dysregulated aldosterone levels, a key contributor to hypertension in about 30% of affected patients.
Mineralys has also highlighted data from its earlier pivotal trial, Advance-HTN, which further supports lorundrostat’s effectiveness in reducing blood pressure across diverse populations. With these latest results in hand, the company is poised to redefine treatment strategies for hypertension, offering new hope to patients struggling for control over a life-threatening condition.
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