RADNOR, PA — Mineralys Therapeutics, Inc. (Nasdaq: MLYS) announced promising topline results from its Phase 2 Explore-CKD trial, evaluating lorundrostat as a treatment for hypertension in patients with chronic kidney disease (CKD). The trial met its primary endpoint, demonstrating significant reductions in systolic blood pressure and urine albumin-to-creatinine ratio (UACR), while maintaining a favorable safety profile.
Lorundrostat 25 mg administered once daily led to a 9.3 mmHg reduction in systolic blood pressure, with a placebo-adjusted decrease of 7.5 mmHg (p=0.0024) after four weeks. The study also reported a substantial 31% reduction in UACR (p<0.0001), a key indicator of kidney health, showing the potential for renal protection alongside hypertension control.
“The Explore-CKD trial is the fourth trial showing clinically meaningful effects of lorundrostat for the treatment of hypertension,” said Jon Congleton, Chief Executive Officer of Mineralys. “This trial demonstrated the benefit of lorundrostat in safely reducing both systolic blood pressure and proteinuria in a renally compromised population. These positive results add to our core data package as we prepare for a planned NDA submission.”
The randomized, double-blind, placebo-controlled crossover trial included patients with CKD and albuminuria on a background of SGLT2 inhibitors and either ACE inhibitors or ARBs. The treatment exhibited a strong safety and tolerability profile, with only 3% of patients discontinuing due to treatment-related adverse events.
Dr. Matthew Weir, Director of the Division of Nephrology at the University of Maryland Medical Center, emphasized lorundrostat’s potential impact. “The evidence generated from this trial demonstrates the unique mechanism of action and benefit of lorundrostat in lowering systolic blood pressure and UACR,” he explained. “Prolonged high blood pressure in CKD patients can damage kidney function. Lorundrostat shows significant promise in managing both hypertension and kidney disease.”
Lorundrostat’s mechanism as an aldosterone synthase inhibitor targets the underlying biology of hypertension, providing dual benefits in blood pressure reduction and kidney protection. The Explore-CKD findings complement previous trials of lorundrostat, including Phase 3 Launch-HTN and Phase 2 Advance-HTN studies, which demonstrated its efficacy in uncontrolled and resistant hypertension.
Mineralys continues to evaluate lorundrostat’s long-term safety and efficacy through its open-label Transform-HTN trial and the ongoing Explore-OSA study, which focuses on patients with sleep apnea and uncontrolled hypertension.
With a growing body of clinical evidence, lorundrostat represents a significant advancement in addressing the complex interplay between hypertension and CKD, offering new hope for improving patient outcomes in these vulnerable populations.
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