Mineralys Therapeutics Finishes Early Enrollment in Second Key Lorundrostat Hypertension Trial

Mineralys Therapeutics, Inc., a clinical-stage biopharmaceutical enterprise focusing on treatments for hypertension, chronic kidney disease (CKD), and other cardiovascular conditions linked to dysregulated aldosterone, has announced the early completion of enrollment for the Launch-HTN trial. This trial is one of two pivotal studies assessing the safety and efficacy of lorundrostat for treating uncontrolled and resistant hypertension. Topline data from the study are now expected in the mid-first half of 2025.

The Chief Medical Officer of Mineralys Therapeutics, David Rodman, MD, highlighted the robust interest from both physicians and patients, which facilitated the earlier-than-anticipated enrollment. This trial is designed to reflect real-world treatment scenarios for uncontrolled and resistant hypertension using lorundrostat in a primary care setting. Rodman expressed anticipation for the forthcoming data and gratitude for the commitment of trial participants and investigators.

The Launch-HTN trial is a global, randomized, double-blinded, placebo-controlled Phase 3 study, enrolling adults who did not achieve their blood pressure goals despite being on two to five antihypertensive medications. Participants were randomized into three groups: one receiving a placebo, another receiving lorundrostat at 50 mg once daily (QD), and a third group starting with 50 mg QD of lorundrostat, which could be increased to 100 mg QD as needed after six weeks. The primary measure of the trial is the change in systolic blood pressure from baseline compared to placebo after six weeks, assessed via automated office blood pressure monitoring.

Mineralys Therapeutics will also host a virtual event featuring Key Opinion Leaders (KOL) to discuss the unmet needs in hypertension treatment and review the ongoing clinical program for lorundrostat, including the details of the Advance-HTN and Launch-HTN trials.

Hypertension, characterized by sustained high blood pressure, significantly elevates the risk of heart disease, heart attack, and stroke, which are leading causes of death in the United States. In 2020, over 670,000 deaths in the U.S. were linked to hypertension, either as a primary or contributing cause. The economic burden of hypertension and related health conditions averaged about $130 billion annually from 2003 to 2014. Less than half of hypertension patients achieve their blood pressure targets with current medications, and dysregulated aldosterone is a key driver of hypertension in approximately 25% of patients.

Lorundrostat is an innovative, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uncontrolled hypertension and CKD. It works by inhibiting the enzyme CYP11B2, thus reducing aldosterone levels. In vitro studies have shown that lorundrostat is 374 times more selective for aldosterone-synthase inhibition compared to cortisol-synthase inhibition. It has a half-life of 10-12 hours and has demonstrated a significant reduction in plasma aldosterone concentration in hypertensive patients.

In a Phase 2 proof-of-concept trial (Target-HTN), lorundrostat showed a meaningful reduction in blood pressure in patients with uncontrolled or resistant hypertension. Adverse events reported included a modest increase in serum potassium, a decrease in estimated glomerular filtration rate, urinary tract infections, and hypertension. One serious adverse event potentially related to lorundrostat was hyponatremia.

Mineralys Therapeutics, based in Radnor, Pennsylvania, was founded by Catalys Pacific. The company is dedicated to developing treatments for cardiorenal conditions influenced by dysregulated aldosterone, including hypertension and CKD. Its leading product candidate is lorundrostat, which is currently under development for these conditions.