Mineralys Therapeutics Announces Late-Breaking Presentation of Data from the Launch-HTN Pivotal Trial of Lorundrostat in Uncontrolled or Resistant Hypertension at 34th European Meeting on Hypertension and Cardiovascular Protection (ESH 2025)

– Largest hypertension trial of an aldosterone synthase inhibitor to date demonstrated the efficacy of lorundrostat in over 1,000 participants with uncontrolled or resistant hypertension in a real-world setting –

– Lorundrostat 50 mg dosed once daily demonstrated clinically meaningful and sustained reductions in systolic blood pressure, with a 16.9 mmHg reduction at Week 6 (-9.1 mmHg placebo adjusted) and a 19.0 mmHg reduction at Week 12 (-11.7mm placebo adjusted) –

– Lorundrostat demonstrated a favorable safety and tolerability profile –

RADNOR, Pa., May 24, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced detailed results from the pivotal Phase 3 Launch-HTN trial in over 1,000 participants with uncontrolled hypertension (uHTN) or resistant hypertension (rHTN) who were taking two to five antihypertensive medications. When added to existing background treatment, lorundrostat 50 mg dosed once daily demonstrated clinically meaningful and sustained reductions in automatized office systolic blood pressure, with a 16.9 mmHg reduction at Week 6 (-9.1 mmHg placebo adjusted; p-value < 0.0001) and a 19 mmHg reduction at Week 12 (-11.7mm placebo adjusted; p-value < 0.0001). Additionally, lorundrostat demonstrated a favorable safety and tolerability profile.

“The detailed results from Launch-HTN, which was 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,” stated Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. “With these findings in hand, we now have data from two pivotal trials in distinct-but-complementary populations that reinforce the promise of a new treatment approach for hypertension that directly addresses the dysregulated aldosterone pathway – a key driver of the condition in many patients.”