Mineralys Therapeutics Presents Target-HTN Phase 2 Trial Results

mineralys therapeutics

RADNOR, PA — Mineralys Therapeutics, Inc. (Nasdaq: MLYS) recently presented final results from the Target-HTN Phase 2 trial of lorundrostat, a highly selective aldosterone synthase inhibitor, in individuals with uncontrolled hypertension (uHTN) and resistant hypertension (rHTN). The data was presented during a late-breaking science session at the 2023 American Heart Association (AHA) Hypertension Scientific Sessions and simultaneously published in the Journal of the American Medical Association (JAMA).

Target-HTN trial results demonstrate treatment with lorundrostat at doses of 50mg and 100mg once daily (QD) led to a statistically and clinically significant reduction of systolic blood pressure (BP) in inadequately controlled hypertensive individuals on at least two background antihypertensive medications. The reduction in BP was particularly evident among participants with hypertension and concomitant obesity.

“The final results from our Target-HTN trial demonstrate lorundrostat had a robust, double-digit reduction in systolic blood pressure with a well-tolerated profile in the intention-to-treat population of individuals with uncontrolled hypertension and resistant hypertension. In support of our targeted development strategy for lorundrostat, a pre-specified sub-analysis of subjects with elevated BMI demonstrated enhanced reduction in systolic blood pressure that is likely due, in part, to visceral fat driving abnormal aldosterone levels,” stated Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. “Results from the Target-HTN trial were instrumental in our decision to advance the ongoing pivotal program and we look forward to announcing the results from our initial pivotal study expected in the first half of 2024.”

Key clinical data from Target-HTN suggest robust BP reductions in the treatment of patients with uHTN and rHTN:

  • Target-HTN successfully met its primary endpoint, demonstrating a statistically significant change from baseline in systolic automated office BP (AOBP) with lorundrostat 50mg (n=28) and 100mg (n=25) QD doses versus placebo (n=29):
    • -13.7 mmHg systolic AOBP change at 50mg QD, or -9.6 mmHg placebo-adjusted change (p=0.01)
    • -11.9 mmHg systolic AOBP change at 100mg QD, or -7.8 mmHg placebo-adjusted change (p=0.04)
  • Key secondary endpoint results demonstrated a change in diastolic AOBP of -7.1 mmHg with 50mg QD (or -5.5 mmHg placebo-adjusted change; p=0.02) and -5.8 mmHg with 100mg QD (or -4.1 mmHg placebo-adjusted change; p=0.09)
  • Other secondary endpoints, including assessment of 24-hour average BP, supported the efficacy of the QD dosing regimen.
  • A pre-specified analysis examined the impact of body mass index (BMI) on the degree of BP lowering with lorundrostat, testing the hypothesis that aldosterone-dependent hypertension may be more significant in obese individuals:
    • With 50mg QD, changes in systolic AOBP were 2.2 mmHg in subjects with a BMI 25-30 kg/m2, versus -16.7 in subjects with a BMI ≥30 kg/m2 (placebo-adjusted; p<0.01)
    • With 100mg QD, changes in systolic AOBP were -4.5 mmHg in subjects with a BMI 25-30 kg/m2, versus -12.3 in subjects with a BMI ≥30 kg/m2 (placebo-adjusted; p=0.03)
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Key safety and tolerability findings from Target-HTN suggest lorundrostat was well‐tolerated with a favorable safety profile, particularly with 50mg lorundrostat QD:

  • Lorundrostat was well tolerated at all dose levels
  • There was a modest, dose-dependent increase in mean serum potassium (0.25-0.29 mmol/L) and low incidence of elevated serum potassium (3.6% subjects with serum potassium levels above 6.0 mmol/L)
  • Three serious adverse events occurred, only one (worsening of pre-existing hyponatremia with 100mg lorundrostat QD) was deemed treatment-related

Target-HTN trial results support the transition to late-stage development of lorundrostat as a treatment for inadequately controlled hypertension. The Company’s ongoing pivotal development program for lorundrostat to treat uHTN and rHTN is currently enrolling subjects in the Advance-HTN trial, and the Phase 3 Launch-HTN trial is expected to be initiated in the second half of the year, with topline data expected in the first half of 2024 and mid-2025, respectively.

The presentation at the 2023 AHA Hypertension Scientific Sessions, titled, “Aldosterone Synthase Inhibition with Lorundrostat for Uncontrolled Hypertension: The Target‐HTN Phase 2 Randomized Clinical Trial,” can be accessed on the publications page of the Mineralys corporate website.

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