On Monday, Mineralys Therapeutics, Inc. (NASDAQ:MLYS) released topline data from its pivotal Launch-HTN Phase 3 and pivotal Advance-HTN Phase 2 trials of lorundrostat for uncontrolled hypertension (uHTN) or resistant hypertension (rHTN).
Both trials achieved statistical significance, were clinically meaningful in their prespecified primary efficacy endpoints, and demonstrated a favorable safety and tolerability profile.
The Launch-HTN trial met the primary endpoint with lorundrostat 50 mg dose achieved a 16.9 mmHg reduction in systolic blood pressure and a 9.1 mmHg placebo-adjusted reduction assessed by automated office blood pressure at week 6.
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Launch-HTN met a predefined endpoint with lorundrostat 50 mg dose achieving a 19.0 mmHg reduction in systolic blood pressure and an 11.7 mmHg placebo-adjusted reduction.
The Advance-HTN trial met its primary endpoint, with a placebo-adjusted reduction from baseline in systolic blood pressure assessed with 24-hour average blood pressure measurement at week 12 of -7.9 mmHg in subjects treated with 50 mg of lorundrostat.
Clinical safety findings from both pivotal trials, including hypotension, serum potassium, eGFR, and serum cortisol, support a favorable benefit-risk profile.
In February, Mineralys Therapeutics completed enrollment in the Explore-CKD Phase 2 trial evaluating the efficacy and safety of lorundrostat for the treatment of hypertension in subjects with CKD and albuminuria, despite receiving stable treatment.
In January, the U.S. Food and Drug Administration (FDA) cleared Mineralys Therapeutics’ Investigational New Drug (IND) Application for a Phase 2 trial of lorundrostat for moderate-to-severe obstructive sleep apnea (OSA) and hypertension. The company anticipates initiating the trial in the first quarter of 2025.
Price Action: MLYS stock is up 65.70% at $17.43 at the last check Monday.
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