Mineralys Therapeutics, Inc. MLYS revealed topline data Tuesday from its Phase 2 Explore-CKD trial, which evaluated 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 systolic automated office blood pressure (AOBP) and urine albumin-to-creatinine ratio (UACR).
It also had a favorable safety and tolerability profile.
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“The Explore-CKD trial is the fourth trial showing clinically meaningful effects of lorundrostat for the treatment of hypertension. In a renally compromised hypertensive population, this trial demonstrated the benefit of lorundrostat in safely reducing both systolic blood pressure and proteinuria – a surrogate of kidney protection…Along with the successful pivotal trials, Launch-HTN and Advance-HTN, and the ongoing open-label extension trial, these results comprise the core package for our planned NDA submission,” said Jon Congleton, CEO of Mineralys.
Two subjects reported serious adverse events during the lorundrostat treatment period and none during the placebo treatment period.
TEAEs leading to discontinuation occurred in one subject (2%) during the placebo treatment period and in two subjects (3%) during the lorundrostat treatment period.
During lorundrostat treatment, one subject discontinued treatment due to an elevation of potassium associated with reduced eGFR. Another subject discontinued treatment due to a reduction in eGFR alone.
During the lorundrostat treatment period, an anticipated, modest decrease in mean eGFR was observed (-6.8% lorundrostat, -4.6% mL/min/1.73m2 placebo-adjusted).
The company continues to study lorundrostat in the ongoing, open-label Transform-HTN extension trial, which is evaluating long-term efficacy, safety, and tolerability.
Additionally, the Explore-OSA trial, initiated in the first quarter of 2025, continues to enroll subjects with OSA and uncontrolled hypertension.
Price Action: At the last check on Tuesday, MLYS stock was up 11.2% at $14.95 during the premarket session.
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