Mineralys Therapeutics, Inc. (NASDAQ: MLYS) has announced the completion of enrollment in the explore-CKD phase 2 trial for lorundrostat, a treatment for hypertension in subjects with stage 2 to 3b chronic kidney disease (CKD) and albuminuria. The topline data from the explore-CKD trial is anticipated to be announced in the second quarter of 2025.
The explore-CKD trial is a randomized, double-blind, placebo-controlled, two-period, two-sequence crossover trial designed to evaluate the efficacy and safety of lorundrostat for the treatment of hypertension in subjects with CKD and albuminuria. The primary efficacy endpoint of the trial is the change from baseline in systolic blood pressure at week four in the active versus placebo treatment period. An exploratory endpoint will be to evaluate change from baseline in urine albumin-to-creatinine ratio at week four in the active versus placebo treatment period.
CKD affects more than 10% of the global population and is estimated to affect approximately 15% of U.S. adults. Diabetes and hypertension are responsible for about two-thirds of CKD cases, making it a significant health concern. Hypertension, on the other hand, is a leading cause of heart disease, heart attack, and stroke, with the economic burden averaging about $130 billion annually in the U.S.
Less than 50% of hypertension patients achieve their blood pressure goal with currently available medications, making the development of treatments like lorundrostat crucial. In a phase 2, proof-of-concept trial (target-HTN), lorundrostat demonstrated clinically meaningful blood pressure reduction in uncontrolled or resistant hypertensive subjects. The adverse events observed were a modest increase in serum potassium, a decrease in estimated glomerular filtration rate, urinary tract infection, and hypertension, with one serious adverse event possibly related to the study drug being hyponatremia.
Mineralys Therapeutics is focused on developing medicines to target hypertension, CKD, obstructive sleep apnea (OSA), and other diseases driven by dysregulated aldosterone, with lorundrostat being its initial product candidate. The company's commitment to addressing the unmet medical needs in these areas is evident through its completion of enrollment in the explore-CKD trial, as well as its ongoing exploration of treatments for other related conditions. The market has reacted to these announcements by moving the company's shares -0.3% to a price of $9.9. If you want to know more, read the company's complete 8-K report here.
