Mineralys Therapeutics, Inc. (Nasdaq: MLYS) has announced the completion of enrollment in its Launch-HTN trial ahead of schedule. Launch-HTN is the second of two pivotal trials evaluating lorundrostat for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN). The company anticipates topline data from the trial will be available in mid first half of 2025.
Trial Design and Objectives
The Launch-HTN trial (NCT06153693) is a global, randomized, double-blinded, placebo-controlled Phase 3 trial. It enrolled adult participants who had not achieved their blood pressure goal despite being on two to five background antihypertensive medications. Participants were randomized to receive either placebo, lorundrostat 50 mg once daily (QD), or lorundrostat 50 mg QD with titration to 100 mg QD at week six, if needed. The primary endpoint is the change from baseline in systolic blood pressure versus placebo after six weeks of treatment, as measured by automated office blood pressure monitoring.
Clinical Significance
"Due to the high interest among treating physicians and patients in the Launch-HTN trial, we have completed enrollment earlier than planned. This trial is designed to model the real-world treatment of uHTN and rHTN using lorundrostat in the primary care setting," said David Rodman, MD, Chief Medical Officer of Mineralys Therapeutics. He added, "We look forward to sharing the topline data from the trial, which are now expected to be available in mid first half of 2025."
Hypertension and Aldosterone
Hypertension, characterized by sustained elevated blood pressure, significantly increases the risk of heart disease, heart attack, and stroke. In 2020, hypertension was a primary or contributing cause in over 670,000 deaths in the U.S. and results in an average annual economic burden of approximately $130 billion. Less than 50% of hypertension patients achieve their blood pressure goal with current medications. Dysregulated aldosterone levels are a key factor in driving hypertension in approximately 25% of all hypertensive patients.
About Lorundrostat
Lorundrostat is an orally administered, highly selective aldosterone synthase inhibitor designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for its production. In vitro studies have shown that lorundrostat has 374-fold selectivity for aldosterone-synthase inhibition versus cortisol-synthase inhibition. It has an observed half-life of 10-12 hours and has demonstrated approximately a 70% reduction in plasma aldosterone concentration in hypertensive subjects.
In a Phase 2 proof-of-concept trial (Target-HTN) in uncontrolled or resistant hypertensive subjects, once-daily lorundrostat demonstrated clinically meaningful blood pressure reduction in both automated office blood pressure measurement and 24-hour ambulatory blood pressure monitoring.
