RADNOR, PA — Mineralys Therapeutics, Inc. (Nasdaq: MLYS) has announced positive topline results from its pivotal Launch-HTN Phase 3 and Advance-HTN Phase 2 trials evaluating lorundrostat for the treatment of uncontrolled hypertension (uHTN) and resistant hypertension (rHTN). Both trials achieved statistically significant outcomes in their primary efficacy endpoints and demonstrated a favorable safety profile, marking a significant step forward in addressing one of the leading global health challenges.
Key Efficacy Findings
The Launch-HTN Phase 3 trial assessed lorundrostat in patients with uncontrolled hypertension who were on two to five antihypertensive medications. Notable findings included a 16.9 mmHg reduction in systolic blood pressure at week 6 with a 9.1 mmHg placebo-adjusted reduction. By the end of the 12-week treatment period, patients achieved a reduction of 19.0 mmHg in systolic pressure, with an 11.7 mmHg placebo-adjusted reduction, reinforcing the drug’s sustained efficacy.
The Advance-HTN Phase 2 trial supported the findings with similarly strong results. This trial targeted patients with confirmed uHTN or rHTN, testing lorundrostat as an add-on therapy to optimized background treatments of two or three existing medications. At 50 mg, lorundrostat demonstrated a placebo-adjusted reduction of 7.9 mmHg in systolic pressure assessed by 24-hour average blood pressure measurements at week 12.
Both trials utilized randomized, double-blinded, placebo-controlled designs to simulate real-world clinical settings. Participants remained on their existing medications throughout the trials, offering insights into lorundrostat’s utility as an add-on therapy.
Favorable Safety Profile
Lorundrostat demonstrated a robust safety and tolerability profile across both trials. Reported treatment-emergent serious adverse events (SAEs) were low, with 2.2% incidence in the Launch-HTN trial’s 50 mg cohort and 0.7% in the 50 mg group with optional dose escalation. The frequency of hyperkalemia remained manageable, observed in 1.1% of patients in the 50 mg arm of the Launch-HTN trial, aligning with expectations for aldosterone-targeting treatments.
According to Jon Congleton, CEO of Mineralys Therapeutics, the trial results underscore lorundrostat’s promise as a targeted treatment for hypertension. “These findings demonstrate strong efficacy and a solid safety profile, confirming the potential for lorundrostat to address the unmet needs of 15 to 20 million patients in the United States with uncontrolled hypertension,” said Congleton.
Broader Impact and Future Plans
Hypertension remains the leading risk factor for cardiovascular events worldwide, underscoring the importance of breakthrough therapies like lorundrostat. Dr. Manish Saxena, a hypertension specialist with Barts Health NHS Trust, remarked on the importance of these results, stating, “Lorundrostat addresses a critical gap in blood pressure management, offering hope to those with limited options for controlling their condition.”
Additional detailed data from Advance-HTN will be presented on March 29, 2025, at the American College of Cardiology Scientific Sessions. Mineralys is also continuing its Transform-HTN open-label extension trial to gather additional long-term efficacy and safety data for lorundrostat.
With three successful clinical trials completed, mineralys is poised to seek regulatory approval for lorundrostat, which has the potential to become a game-changing therapy for millions of patients with high blood pressure.
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