Announcement • Jun 15

Mineralys Therapeutics Presents Late-Breaking Data on Lorundrostat and Heart Failure Risk Biomarkers At the Endocrine Society Annual Meeting

Mineralys Therapeutics, Inc. presented new data on the effect of lorundrostat on heart failure risk biomarkers. This post hoc analysis of circulating proteomic data from participants enrolled in the Company’s Launch-HTN and Advance-HTN trials was presented in a late-breaking poster presentation at ENDO 2026, the Endocrine Society's annual meeting in Chicago, Illinois. This analysis characterized the systemic pharmacodynamic effects of lorundrostat and generated hypotheses regarding its potential modulation of pathways implicated in heart failure pathophysiology by profiling circulating protein biomarkers at baseline and after 12 weeks from 1,004 participants enrolled in the pivotal Phase 3 Launch-HTN and Phase 2b Advance-HTN trials. The pharmacodynamic analysis confirmed that lorundrostat was associated with significant increases in renin and decreases in angiotensinogen, reflecting target engagement of the renin-angiotensin-aldosterone system. Lorundrostat was associated with significant reductions in 6 of 11 recently published candidate causal risk biomarkers of incident heart failure, including NT-proBNP, consistent with the hypothesis that renin-angiotensin-aldosterone system inhibition favorably modulates processes involved in heart failure risk. Compared to placebo, lorundrostat treatment led to coordinated changes in key biomarkers: reductions in markers of scarring and heart failure risk and increases in markers of hemostasis and protease inhibitor activity. These changes occurred together, suggesting a broad, consistent effect on disease pathways—particularly reducing harmful fibrosis—rather than isolated, random shifts. These results provide biological plausibility and support further evaluation of the therapeutic potential of lorundrostat in heart failure. Lorundrostat is currently under review by the U.S. Food and Drug Administration, with a Prescription Drug User Fee Act target date of December 22, 2026. The Launch-HTN trial was a global, randomized, Phase 3 double-blind, placebo-controlled clinical trial of adults whose blood pressure remained uncontrolled despite being on two to five antihypertensive medications. Participants were assigned to one of three groups: lorundrostat 50 mg once daily; lorundrostat 50 mg once daily with the option to increase to 100 mg at week six based on prespecified criteria; or placebo. The primary endpoint was change from baseline in systolic blood pressure at six weeks versus placebo, measured by automated office blood pressure monitoring. The Advance-HTN trial was a randomized, Phase 2 double-blind, placebo-controlled clinical trial that evaluated the efficacy and safety of lorundrostat for the treatment of uncontrolled hypertension or resistant hypertension, when used as an add-on therapy to a standardized background treatment of two or three antihypertensive medications in adult participants. Participants who met screening criteria had their existing hypertension medications discontinued and started on a standard regimen of an angiotensin II receptor blocker and a diuretic, if previously on two medications, or a standard regimen of angiotensin II receptor blocker, diuretic and calcium channel blocker if previously on three to five medications. Participants who remained hypertensive despite the standardized regimen were then randomized into three cohorts and treated for 12 weeks: lorundrostat 50 mg once-daily; lorundrostat 50 mg once-daily with the option to increase to 100 mg once-daily at week four based on prespecified criteria; or placebo. The primary endpoint was the change in 24-hour ambulatory systolic blood pressure at week 12 from baseline for active cohorts versus placebo. Lorundrostat is an investigational proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uncontrolled hypertension or resistant hypertension, as well as related comorbidities, such as chronic kidney disease, obstructive sleep apnea and other diseases driven by dysregulated aldosterone. Lorundrostat was designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for its production. Lorundrostat has 374-fold selectivity for aldosterone-synthase inhibition versus cortisol-synthase inhibition in vitro, an observed half-life of 10-12 hours and demonstrated a 40-70% reduction in plasma aldosterone concentration in participants with hypertension. Mineralys has now completed six late-stage clinical trials of lorundrostat supporting the efficacy and safety profile while also validating aldosterone as an integral therapeutic target in uncontrolled hypertension and resistant hypertension. This includes two pivotal, registrational trials: the Phase 3 Launch-HTN trial and the Phase 2 Advance-HTN trials of lorundrostat, which support the robust, durable and clinically meaningful reductions in systolic blood pressure by lorundrostat. Lorundrostat was well tolerated in both trials with a favorable safety profile.

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Hypertension And Cardiorenal Catalysts Will Reshape Long Term Prospects For This Biotech

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