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Mineralys Therapeutics Announces Publication of Pivotal Phase 2 Advance-HTN Results in the New England Journal of Medicine (NEJM)
– Significant blood pressure reductions among patients with uncontrolled or resistant hypertension treated with lorundrostat reinforce key role of
About this update from Mineralys Therapeutics, Inc.
[{"type":"text","content":"– Significant blood pressure reductions among patients with uncontrolled or resistant hypertension treated with lorundrostat reinforce key role of dysregulated aldosterone in disease onset and progression – – Detailed results from the second pivotal Phase 3 Launch-HTN trial to be presented at an upcoming medical conference and published in a peer-reviewed publication – RADNOR, Pa., April 23, 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 that the New England Journal of Medicine (NEJM) published the detailed results from the Company’s pivotal Phase 2 Advance-HTN trial, the first of two pivotal trials evaluating lorundrostat in patients with uncontrolled hypertension (uHTN) or resistant hypertension (rHTN). The full manuscript is titled, “Lorundrostat Efficacy and Safety in Patients with Uncontrolled Hypertension,” and is featured in the April 23, 2025 issue of NEJM. The key data from the publication showed that lorundrostat 50 mg demonstrated a 15.4 mmHg absolute reduction and a 7.9 mmHg placebo-adjusted reduction (p=0.001), in 24-hour ambulatory blood pressure at week 12. Lorundrostat worked equally well in those taking two baseline medications and those taking three or more, and in both men and women as well as in white and black patients. Lorundrostat demonstrated a favorable safety and tolerability profile, with modest changes in potassium, sodium and eGFR. “The publication of our Advance-HTN trial results in the New England Journal of Medicine is a significant milestone that underscores both the strength of our clinical data and the potentially transformative nature of this new class of medicines that could help address dysregulated aldosterone, an unaddressed, key driver of hypertension,” stated Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. “Prior studies have shown that even modest reductions in systolic blood pressure can lead to a substantial decrease in the incidence of major cardiovascular events. The blood pressure reductions with lorundrostat observed in the Advance-HTN trial are particularly meaningful given the well-established correlation between...