Mineralys Therapeutics Announces Late-Breaking Data from Advance-HTN Pivotal Trial of Lorundrostat in Uncontrolled and Resistant Hypertension Presented at the American College of Cardiology’s Annual Scientific Session & Expo (ACC.25)

Core Insights - Lorundrostat has shown significant efficacy in reducing blood pressure in patients with uncontrolled or resistant hypertension, achieving a 15.4 mmHg absolute reduction and a 7.9 mmHg placebo-adjusted reduction at week 12 [1][3] - The drug is a highly selective aldosterone synthase inhibitor, targeting aldosterone biosynthesis rather than blocking mineralocorticoid receptors, positioning it as a potential best-in-class treatment for high-risk patients [1][12] - The favorable safety and tolerability profile of lorundrostat, with low discontinuation rates and manageable on-target effects, supports its use in a specialist setting for complex hypertension cases [6][7] Efficacy Results - The Advance-HTN trial was a randomized, double-blind, placebo-controlled Phase 2 trial assessing lorundrostat's efficacy as an add-on therapy to existing antihypertensive medications [3][14] - At week 4, lorundrostat 50 mg demonstrated an 11.5 mmHg absolute change and a 5.3 mmHg placebo-adjusted change in 24-hour average systolic blood pressure [4] - A significant proportion of patients (41%) achieved a 24-hour average systolic blood pressure of less than 125 mmHg at week 4 compared to 18% on placebo [5] Safety and Tolerability Results - Lorundrostat exhibited a favorable safety profile with modest changes in potassium, sodium, and estimated glomerular filtration rate (eGFR), and a low incidence of serious adverse events [6][10] - The incidence of hyperkalemia was confirmed at 2.1% and 3.2% for the 50 mg and 50 to 100 mg doses, respectively, after excluding spurious results [10] - The study population included a high proportion of historically underrepresented individuals, with 40% women and 53% Black patients, highlighting the drug's potential impact on diverse demographics [7] Company Overview - Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for hypertension, chronic kidney disease, and obstructive sleep apnea driven by dysregulated aldosterone [15] - The company plans to present additional data from the pivotal Phase 3 Launch-HTN trial at upcoming medical conferences and in peer-reviewed publications [7] - Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific, emphasizing its commitment to addressing significant unmet needs in hypertension care [15]