RADNOR, PA — Mineralys Therapeutics, Inc. (Nasdaq: MLYS) announced new subgroup analyses from its Phase 3 Launch-HTN trial, showing that its investigational therapy lorundrostat significantly lowered blood pressure across multiple high-risk populations with uncontrolled or resistant hypertension. The findings were presented at the American Heart Association’s Hypertension Scientific Sessions in Baltimore.
The Launch-HTN trial is the largest global Phase 3 study in uncontrolled or resistant hypertension, enrolling 1,083 adults who failed to achieve blood pressure goals despite being on two to five medications. The trial population reflected the real-world diversity of patients most affected by hypertension: 29% were Black or African American, 41% were aged 65 or older, 47% were women, 63% had obesity, and 60% required at least three background antihypertensive drugs.
Lorundrostat 50 mg once daily demonstrated consistent and statistically significant reductions in blood pressure across all these subgroups compared with placebo. Results showed an average automated office systolic blood pressure reduction of 16.9 mmHg at Week 6 and 19.0 mmHg at Week 12, translating to placebo-adjusted reductions of 9.1 mmHg and 11.6 mmHg, respectively (p<0.0001 for both).
“Lorundrostat demonstrated a clinically meaningful blood pressure reduction across the full study population, including these difficult-to-treat groups,” said Jon Congleton, CEO of Mineralys Therapeutics. “Importantly, the safety and tolerability profile was consistent with our topline results, reinforcing the potential of lorundrostat as a transformative therapeutic for patients living with uncontrolled or resistant hypertension.”
Safety results were favorable, with no new signals observed. Adverse events were generally mild to moderate, and anticipated changes in serum electrolytes were modest and reversible upon discontinuation. Serious drug-related events were rare, with very few leading to discontinuation or dose adjustments.
Hypertension specialist Dr. Manish Saxena of Barts Health NHS Trust emphasized the clinical importance of the findings, noting that consistent blood pressure control across diverse, high-risk subgroups “could help improve outcomes for patients and reduce the burden of hypertension on the healthcare system.”
Mineralys plans to advance lorundrostat toward regulatory approval, with a pre-NDA meeting scheduled with the FDA in the fourth quarter of 2025. The company intends to file a New Drug Application by late 2025 or early 2026.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.