Mineralys Therapeutics' Hypertension Drug Lorundrostat Shows Promising Results in Multiple Clinical Trials

Mineralys Therapeutics has reported positive results from its latest phase 2 clinical trial for lorundrostat, an aldosterone synthase inhibitor designed to treat hypertension. The drug continues to demonstrate its potential in reducing blood pressure across various patient populations, including those with chronic kidney disease (CKD).

Explore-CKD Study Highlights Efficacy in Hypertensive CKD Patients

The phase 2 Explore-CKD study, involving 59 patients with hypertension and CKD, evaluated a 25-mg dose of lorundrostat. After four weeks of treatment, patients receiving the drug experienced a mean systolic blood pressure reduction of 9.25 mmHg, compared to a 1.76-mmHg drop in the placebo group. This significant difference allowed the study to meet its primary endpoint.

Additionally, lorundrostat showed promise in addressing kidney-related issues. The treatment group saw a clinically meaningful 30.5% reduction in urine albumin-to-creatinine ratio, a measure of kidney damage, compared to a 6.6% decrease in the placebo group.

Jon Congleton, CEO of Mineralys, emphasized the importance of these findings, stating, "In a renally compromised hypertensive population, this trial demonstrated the benefit of lorundrostat in safely reducing both systolic blood pressure and proteinuria—a surrogate of kidney protection."

Recent Clinical Successes and Path to FDA Approval

The Explore-CKD results follow a series of positive outcomes for lorundrostat. In March, Mineralys reported successful phase 3 and phase 2 results, demonstrating the drug's efficacy in reducing systolic blood pressure in over 1,000 adults with uncontrolled or resistant hypertension.

Mineralys is maintaining its previously announced timeline, with plans to hold a pre-NDA meeting with the FDA in the fourth quarter of this year. The company aims to submit an approval application for lorundrostat shortly after. Congleton noted that the Explore-CKD trial marks "the fourth trial showing clinically meaningful effects of lorundrostat for the treatment of hypertension."

Safety Profile and Competitive Landscape

While lorundrostat has shown promising efficacy, safety considerations remain crucial. In the Explore-CKD study, two patients receiving lorundrostat reported serious adverse events, compared to none in the placebo group. One patient discontinued treatment due to elevated potassium levels associated with reduced estimated glomerular filtration rate (eGFR), while another stopped due to reduced eGFR alone. Despite these incidents, Mineralys described the drug as having a "favorable safety and tolerability profile."

The positive results for lorundrostat further validate the approach of inhibiting the aldosterone synthase enzyme to lower blood pressure hormone levels. This strategy has attracted attention from other pharmaceutical companies, including AstraZeneca, which entered the space through its $1.8 billion acquisition of CinCor Pharma in 2023.

As Mineralys Therapeutics prepares for potential FDA approval, the pharmaceutical industry watches closely to see if lorundrostat will become a new option for patients struggling with hypertension, particularly those with complicating factors such as chronic kidney disease.