RADNOR, PA — Mineralys Therapeutics, Inc. (Nasdaq: MLYS) has reached a significant milestone in its Advance-HTN trial by hitting its enrollment target of 261 participants. This pivotal trial is crucial in assessing the efficacy and safety of lorundrostat, a potential treatment for uncontrolled and resistant hypertension. The trial focuses on patients who have not achieved desired blood pressure levels despite being on two or three antihypertensive medications.
The Advance-HTN trial is designed as a randomized, double-blind, placebo-controlled Phase 2 study. Participants whose existing hypertension treatments are ineffective will have their medications replaced with a standardized regimen. Those on two medications will switch to an angiotensin II receptor blocker (ARB) and a diuretic, while those on three to five medications will add a calcium channel blocker to this combination. After this adjustment, participants who remain hypertensive will be randomized into three groups for a 12-week treatment period. The groups will receive either 50 mg of lorundrostat, with an option to increase to 100 mg at week four, or a placebo.
Dr. David Rodman, Chief Medical Officer of Mineralys Therapeutics, expressed optimism about the trial’s progress: “We are excited to achieve target enrollment in our pivotal Advance-HTN trial. It is our goal to provide meaningful improvement in cardiovascular risk for people struggling to achieve their optimal blood pressure level.”
The company anticipates releasing topline data from the trial in the first quarter of 2025. This data could be pivotal for advancing lorundrostat as a viable option for patients with challenging hypertension cases.
In addition to the trial’s progress, Mineralys Therapeutics will host a virtual Key Opinion Leader (KOL) event on October 30, 2024. This session aims to provide investors and stakeholders with insights into current hypertension treatments and the ongoing development of lorundrostat.
This trial marks a critical step for Mineralys in addressing the needs of individuals with hypertension that does not respond well to standard treatments. With the potential of lorundrostat, the company hopes to offer a new, effective solution for managing this chronic condition.
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