Tuesday, July 18, 2023
Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company specializing in the development of medicines to target diseases driven by elevated aldosterone levels, has revealed plans for an expanded Phase 2 clinical trial involving lorundrostat. The trial aims to assess lorundrostat as a potential treatment for patients with Stage 2 to 4 chronic kidney disease (CKD). Patient enrollment is expected to commence in the second half of 2023.
The trial expansion comes as a result of positive findings from Mineralys Therapeutics' Target-HTN trial, which demonstrated the improvement of aldosterone-mediated uncontrolled hypertension with lorundrostat. With over 35 million adults in the U.S. affected by CKD, the company believes lorundrostat may offer significant clinical benefits due to its impact on aldosterone, a hormone implicated in CKD development and progression.
The Phase 2 trial will consist of two parts: Part A, a proof-of-concept section, and Part B, a profiling section. Part A will be a randomized, double-blind, placebo-controlled trial involving up to 100 subjects with mild to moderate CKD and persistent albuminuria. Participants will receive a combination treatment of lorundrostat 50 mg and dapagliflozin 10 mg or a placebo once daily for 12 weeks, followed by a 12-week treatment period with lorundrostat alone.
Part B will be an open-label, single-arm, dose escalation trial involving up to 20 subjects with moderate to severe CKD. Subjects will receive lorundrostat at a dose of 25 mg for four weeks, followed by an increase to 50 mg for another four weeks. The primary objective of Part B is to evaluate the safety profile of lorundrostat in individuals with compromised renal function.
Interim data analyses may be conducted during the trial, and the release of topline data is anticipated between the fourth quarter of 2024 and the first quarter of 2025.
Chronic kidney disease, characterized by progressive kidney function loss, affects more than 10% of the global population and is a leading cause of mortality worldwide. Early detection and treatment can help manage the condition, but if left untreated, it can lead to kidney failure requiring dialysis or a kidney transplant.
Lorundrostat, an orally administered aldosterone synthase inhibitor developed by Mineralys Therapeutics, specifically targets aldosterone production. Previous studies have shown its potential in reducing plasma aldosterone concentration in hypertensive subjects, indicating its potential efficacy in treating uncontrolled hypertension and chronic kidney disease.