Mineralys enhances lorundrostat data package ahead of planned NDA

US biopharma Mineralys Therapeutics (Nasdaq: MLYS) has announced positive top-line data from its Phase II Explore-CKD trial evaluating the safety and efficacy of 25mg of lorundrostat in subjects with hypertension and comorbid chronic kidney disease (CKD).

The crossover trial met the primary endpoint and demonstrated clinically-meaningful reductions in both systolic automated office blood pressure and urine albumin-to-creatinine ratio (UACR), and demonstrated a favorable safety and tolerability profile. 

Lorundrostat 25mg once daily achieved a 9.3 mmHg reduction in systolic blood pressure, and a 7.5 mmHg placebo-adjusted decrease at four weeks, while it showed a clinically meaningful decline in the pre-defined endpoint spot UACR of 31%.