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Investing.com -- Mineralys Therapeutics Inc (NASDAQ:MLYS) stock surged 7.9% after reporting positive topline data from its Phase 2 Explore-CKD trial for lorundrostat in patients with hypertension and chronic kidney disease.
The trial met its primary endpoint, showing a clinically meaningful 7.5 mmHg reduction in systolic blood pressure compared to placebo, which was highly statistically significant (p=0.0024). Additionally, the drug demonstrated a 25.6% reduction in urine albumin-to-creatinine ratio (UACR), a key marker of kidney function, compared to placebo (p=0.0015).
Lorundrostat 25 mg once daily demonstrated a favorable safety profile, with only two subjects (3%) experiencing treatment-emergent adverse events leading to discontinuation during the lorundrostat treatment period. The trial showed an anticipated modest decrease in estimated glomerular filtration rate (eGFR), similar to effects seen with other renin-angiotensin-aldosterone pathway inhibitors.
"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."
The crossover trial evaluated lorundrostat added to background treatment that included a sodium-glucose cotransporter 2 inhibitor and either an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker in CKD subjects with compromised kidney function.
This latest data adds to previous positive results from three completed trials of lorundrostat in uncontrolled hypertension, including the pivotal Phase 3 Launch-HTN trial.
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