RADNOR, PA — Mineralys Therapeutics, Inc. (NASDAQ: MLYS) will present new long-term efficacy and safety data for lorundrostat in November, providing an additional clinical readout as the company advances the investigational hypertension treatment following six late-stage trials.
Results from the ongoing Transform-HTN open-label extension trial have been selected for a late-breaking science presentation at the American Heart Association Scientific Sessions 2026, scheduled for Nov. 6-9 in Chicago.
Transform-HTN is evaluating the long-term safety, efficacy and tolerability of lorundrostat in patients with hypertension who completed one of three eligible parent studies: Advance-HTN, Launch-HTN or Explore-CKD.
The study’s primary endpoint is the change in automated office systolic blood pressure.
Manish Saxena, deputy clinical co-director of Queen Mary University of London’s William Harvey Heart Centre and a hypertension specialist at Barts Health NHS Trust, will present the results Nov. 8 at 3:30 p.m. CT.
Lorundrostat is an oral aldosterone synthase inhibitor designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for aldosterone production. Mineralys is developing the drug for uncontrolled and resistant hypertension as well as related conditions including chronic kidney disease and obstructive sleep apnea.
The company reported that lorundrostat has demonstrated a 40% to 70% reduction in plasma aldosterone concentrations among participants with hypertension. The investigational drug has an observed half-life of 10 to 12 hours and showed 374-fold selectivity for aldosterone-synthase inhibition compared with cortisol-synthase inhibition in vitro.
Mineralys has completed six late-stage trials of lorundrostat, including the Phase 3 Launch-HTN and Phase 2 Advance-HTN registrational studies. The company reported reductions in systolic blood pressure and described the drug as well tolerated in both trials.
The development program targets a large population in which existing therapies often fall short. According to figures provided by Mineralys, fewer than half of patients with hypertension reach their blood-pressure goals with currently available medications, while dysregulated aldosterone contributes to hypertension in about 30% of patients.
Hypertension was listed as a primary or contributing cause in more than 685,000 U.S. deaths in 2022, according to data cited by the company. Mineralys also cited an estimated U.S. economic burden of about $219 billion annually in 2019.
The Transform-HTN presentation, titled “Long-Term Efficacy and Safety of Lorundrostat, a Novel Aldosterone Synthase Inhibitor, in Uncontrolled Hypertension,” will be part of a session focused on optimizing antihypertensive therapy.
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