RADNOR, PA — Mineralys Therapeutics, Inc. (Nasdaq: MLYS) announced the swift completion of participant enrollment in its Launch-HTN trial, a critical component of its pivotal program investigating lorundrostat for the treatment of uncontrolled and resistant hypertension. This advancement positions the company to release topline data by the mid-first half of 2025, earlier than initially anticipated.
The Launch-HTN trial is designed as a global, Phase 3 study that is both randomized and double-blinded, featuring a placebo-controlled format. It involves adults whose blood pressure remains uncontrolled despite the use of two to five antihypertensive medications. Participants are assigned to one of three groups: a placebo group, a group receiving lorundrostat 50 mg once daily, or a group starting at 50 mg with the possibility of titration to 100 mg daily after six weeks.
The trial’s primary aim is to assess changes in systolic blood pressure from baseline compared to placebo over a six-week period, utilizing automated office blood pressure monitoring to ensure precise readings.
David Rodman, MD, Chief Medical Officer of Mineralys Therapeutics, highlighted the keen interest from both clinicians and patients which facilitated the earlier-than-expected enrollment. “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,” he stated.
Dr. Rodman further expressed anticipation for the forthcoming results, saying, “We look forward to sharing the topline data from the trial, which are now expected to be available in mid first half of 2025. We greatly appreciate the enthusiasm and commitment that participating trial investigators and trial participants have shown to the development program for lorundrostat.”
With the completion of enrollment, Mineralys Therapeutics continues to advance its efforts to provide innovative solutions for hypertension management, potentially reshaping treatment protocols in the field.
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