Mineralys Therapeutics, Inc. presented data from the Target-HTN Phase 2 trial that further defines an endotype-specific targeted approach for treating uncontrolled or resistant hypertension with lorundrostat, a highly selective aldosterone synthase inhibitor. The data were presented in a poster at the American Heart Association (AHA) Scientific Sessions 2023, which is being held in Philadelphia from November 11th ?13th. Data previously presented from Target-HTN showed that elevated body mass index (BMI) was predictive of an enhanced reduction in systolic blood pressure (BP) from lorundrostat treatment.

The poster presented at the AHA Scientific Sessions 2023 included a new analysis of serum leptin levels among subjects in the trial, which showed that increased BMI was correlated with increased leptin circulation. This is consistent with emerging evidence of a leptin-driven, positive feedback loop between obesity, aldosterone and hypertension. A pre-specified analysis from Target-HTN showed that subjects with a BMI >30kg/m2 experienced placebo-adjusted reductions in systolic BP of 16.7mmHg (p=0.002) and 12.3mmHg (p=0.03) with lorundrostat 50mg and 100mg once-daily (QD) doses, respectively.

Findings from the new analysis showed that the same BMI range was associated with a 75% increase in mean serum leptin (21.6 ±1.9ng/mL in subjects with a BMI =30kg/m2 compared to 37.8 ±2.4ng/mL in subjects with a BMI >30kg/m2; p<0.001), indicating that increased circulating leptin may be a useful biomarker to identify lorundrostat-responsive individuals. The Target-HTN trial demonstrated that treatment with lorundrostat at doses of 50mg and 100mg QD led to a statistically and clinically significant reduction of systolic BP in uncontrolled hypertensive individuals on at least two background antihypertensive medications. Full results from the trial were published in the Journal of the American Medical Association (JAMA) and simultaneously presented during a late-breaking science session at the 2023 AHA Hypertension Scientific Sessions in September.

Target-HTN trial results support the transition to late-stage development of lorundrostat as a treatment for uncontrolled or resistant hypertension. The Company?s ongoing pivotal development program for lorundrostat to treat uncontrolled or resistant hypertension is currently enrolling subjects in the pivotal Advance-HTN trial, and the second pivotal trial, Launch-HTN, trial is expected to be initiated in the second half of 2023.