Mineralys announces its Phase 2 Explore-CKD trial met primary endpoint

Mineralys Therapeutics (MLYS) announced positive topline data from its Phase 2 Explore-CKD trial evaluating the safety and efficacy of 25 mg of lorundrostat in subjects with hypertension and comorbid CKD. The crossover trial met the primary endpoint and demonstrated clinically meaningful reductions in both systolic automated office blood pressure, AOBP, and urine albumin-to-creatinine ratio, and demonstrated a favorable safety and tolerability profile. The Explore-CKD trial was a randomized, double-blind, placebo controlled, crossover trial. This phase 2 trial was designed to evaluate efficacy in terms of systolic blood pressure and UACR reduction, and safety of four-week 25 mg once daily lorundrostat added to a background treatment that included a sodium-glucose cotransporter 2 inhibitor and an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker in CKD subjects with an estimated glomerular filtration rate greater than or equal to 30 mL/min/1.73m2 and albuminuria. The trial was highly statistically significant and was clinically meaningful in both of these endpoints and demonstrated a favorable safety and tolerability profile.