Mineralys Therapeutics announced positive Phase 2 Advance-HTN trial results for lorundrostat, a novel treatment for uncontrolled or resistant hypertension (uHTN/rHTN), published in the New England Journal of Medicine. The study showed lorundrostat significantly reduced 24-hour ambulatory blood pressure, demonstrating consistent efficacy across patient subgroups. This achievement follows prior positive topline data releases and a late-breaking presentation at the American College of Cardiology’s Annual Scientific Session.
This news is important because current hypertension treatments often fall short of achieving target blood pressure levels, particularly for patients with uHTN/rHTN who have not responded adequately to existing medications. Lorundrostat targets aldosterone synthase, an enzyme responsible for producing aldosterone, a hormone implicated in hypertension. This mechanism offers a novel approach to blood pressure control, potentially benefiting patients who have limited effective treatment options and remain at high risk for cardiovascular events.
The Advance-HTN trial showed lorundrostat 50mg achieved a 15.4 mmHg absolute reduction and a 7.9 mmHg placebo-adjusted reduction in 24-hour ambulatory blood pressure at 12 weeks. Importantly, the drug’s safety profile appeared favorable, with only modest changes in potassium, sodium, and estimated glomerular filtration rate (eGFR). These findings highlight lorundrostat’s potential to address a significant unmet medical need in hypertension management. Further data from the Phase 3 Launch-HTN trial and an ongoing open-label extension study will provide additional information regarding the drug’s long-term efficacy and safety.
The positive results from the Advance-HTN trial, coupled with forthcoming data from the Launch-HTN trial, position lorundrostat as a potential game-changer in hypertension treatment. Confirmation of these findings in larger, later-stage trials could lead to a new therapeutic option for patients struggling with uncontrolled or resistant hypertension, improving their cardiovascular outcomes and quality of life. The ongoing research also holds promise for expanding lorundrostat’s application to other aldosterone-mediated diseases like chronic kidney disease and obstructive sleep apnea.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
