Shares of Mineralys Therapeutics Inc. (NASDAQ:MLYS) jumped 7.9% following the release of promising topline data from the company’s Phase 2 Explore-CKD study evaluating lorundrostat in patients with chronic kidney disease (CKD) and hypertension.
The trial reached its primary endpoint, demonstrating a notable 7.5 mmHg reduction in systolic blood pressure compared to placebo — a result deemed highly statistically significant (p=0.0024). Additionally, the treatment group saw a 25.6% decrease in the urine albumin-to-creatinine ratio (UACR), a key biomarker linked to kidney health, also achieving statistical significance (p=0.0015).
Lorundrostat, administered at 25 mg once daily, was well tolerated, with only 3% of patients (two individuals) experiencing adverse events that led to discontinuation during the treatment period. The trial also showed a modest expected reduction in estimated glomerular filtration rate (eGFR), consistent with similar therapies targeting the renin-angiotensin-aldosterone system.
“The Explore-CKD trial is the fourth trial showing clinically meaningful effects of lorundrostat for the treatment of hypertension,” said Jon Congleton, Chief Executive Officer of Mineralys. “Along with the successful pivotal trials, Launch-HTN and Advance-HTN, and the ongoing open-label extension trial, these results comprise the core package for our planned NDA submission.”
Conducted as a crossover study, the trial assessed lorundrostat in patients already receiving a treatment regimen that included a sodium-glucose cotransporter 2 (SGLT2) inhibitor, along with either an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB). Participants had underlying kidney impairment and elevated blood pressure.
These results add to an expanding body of favorable clinical evidence for lorundrostat, including three prior studies targeting uncontrolled hypertension, most notably the pivotal Phase 3 Launch-HTN trial.