Mineralys Therapeutics Unveils Trial Results Showcase Lorundrostat in Hypertension Treatment

March 10, 2025

DENVER, Colo., Mar 10, 2025 (247marketnews.com)- Mineralys Therapeutics (NASDAQ:MLYS) reported positive topline results from its pivotal Launch-HTN Phase 3 and Advance-HTN Phase 2 trials. These studies, evaluating the efficacy and safety of lorundrostat for uncontrolled hypertension (uHTN) and resistant hypertension (rHTN), met their pre-specified primary efficacy endpoints with statistically significant and clinically meaningful outcomes. Beyond efficacy, lorundrostat showcased a favorable safety and tolerability profile, positioning it as a potential breakthrough for millions struggling with hard-to-control blood pressure.

Manish Saxena MBBS, Hypertension Specialist from Barts Health NHS Trust, stated, “The Launch-HTN study evaluating novel drug lorundrostat is one of the largest blood pressure studies in recent times and demonstrates its benefit in lowering blood pressure and its safety in a diverse group of patients whose hypertension is not well controlled. Uncontrolled and resistant hypertension remains a global health concern as it continues to be the leading cause of cardiovascular deaths, heart attacks and strokes. Given today’s announcement, lorundrostat could be a good treatment option for millions of patients with high blood pressure.”

The Launch-HTN trial, a global, randomized, double-blind, placebo-controlled Phase 3 study, enrolled 1,083 adults whose blood pressure remained stubbornly high despite two to five antihypertensive medications. Designed to mirror real-world clinical practice, the trial utilized automated office blood pressure (AOBP) measurements and allowed participants to continue their existing regimens while adding lorundrostat. At a 50 mg daily dose, lorundrostat achieved a 16.9 mmHg reduction in systolic blood pressure from baseline by week 6, translating to a 9.1 mmHg placebo-adjusted drop (p<0.0001)—the trial’s primary endpoint. By week 12, the end of treatment, the effect deepened to a 19.0 mmHg absolute reduction and an 11.7 mmHg placebo-adjusted decrease (p<0.0001). Even in the dose-escalation arm, starting at 50 mg and optionally rising to 100 mg, a solid 15.7 mmHg absolute reduction and 8.4 mmHg placebo-adjusted decrease (p=0.0016) emerged by week 6. Across both uncontrolled (two background drugs) and resistant (three to five drugs) cohorts, lorundrostat’s impact was consistent and significantly outperformed placebo.

Meanwhile, the Advance-HTN trial, a randomized, double-blind, placebo-controlled Phase 2 study, took a complementary approach, testing lorundrostat as an add-on to an optimized regimen of two or three antihypertensive drugs in patients with confirmed uHTN or rHTN. Using the rigorous 24-hour ambulatory blood pressure monitoring (ABPM) method, it met its primary endpoint with a 7.9 mmHg placebo-adjusted reduction in systolic blood pressure at week 12 on the 50 mg dose—a highly statistically significant result. Other pre-specified measures, including efficacy in the dose-escalation cohort and safety outcomes, aligned closely with Launch-HTN’s findings, though full details remain under embargo until their unveiling at the American College of Cardiology Scientific Sessions on March 29, 2025.

Jon Congleton, CEO of Mineralys, commented, “The positive results and clinically meaningful reduction in blood pressure observed in the Launch-HTN and Advance-HTN trials show us that lorundrostat has the potential to be a transformative new therapy for the approximately 15 to 20 million patients with uncontrolled hypertension in the United States. We have now completed three successful clinical trials demonstrating the efficacy, safety and tolerability of lorundrostat and the importance of targeting dysregulated aldosterone. We believe the clinical profile observed for lorundrostat supports the potential regulatory approval of this novel agent and its significant commercial value. We appreciate the commitment and hard work of the clinical investigators, site staff, the Mineralys and Cleveland Clinic research teams, and especially the trial subjects who volunteered to participate in our program.”

Safety and tolerability bolstered these efficacy wins. Across both trials, lorundrostat’s clinical profile—including effects on hypotension, serum potassium, eGFR, and cortisol—supported a compelling benefit-risk balance. In Launch-HTN, treatment-emergent serious adverse events (SAEs) occurred in 12 subjects (2.2%) in the 50 mg arm and two (0.7%) in the 50-to-100 mg escalation arm, compared to eight (3.0%) in the placebo group, with only one treatment-related SAE (0.1%) in the 50 mg arm. Hyperkalemia, defined as serum potassium above 6.0 mmol/L, registered at 1.1% and 1.5% in Launch-HTN’s 50 mg and 50-to-100 mg arms, respectively, and 5.3% and 7.4% in Advance-HTN—rates deemed manageable for an aldosterone-targeting therapy. These findings reinforce lorundrostat’s promise as a safe, potent option.

Mineralys plans to share deeper insights from both trials at upcoming medical conferences and in peer-reviewed journals.

Hypertension affects over 115 million Americans.

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