Mineralys Therapeutics has dosed the first patient in its ADVANCE-HTN pivotal trial to evaluate lorundrostat as an add-on therapy for the treatment of uncontrolled hypertension (uHTN) and resistant hypertension (rHTN).
The randomised, double-blind, placebo-controlled study will assess the safety and efficacy of lorundrostat in around 300 adult patients to standardised background treatment of two or three antihypertensive medications.
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Patients will be divided into three arms to receive a placebo, lorundrostat 50mg once-daily (QD), and lorundrostat 50mg QD and then titrated to 100mg QD, as needed, at week four.
Change in systolic blood pressure versus placebo after treatment for 12 weeks, as measured by 24-hour ambulatory blood pressure monitoring, is the primary endpoint of the study.
Mineralys CEO Jon Congleton said: “Over half of all treated hypertension patients fail to achieve their goal blood pressure and many continue to experience increased cardiorenal morbidity and mortality risk.
“Abnormal aldosterone production is considered a key driver in uncontrolled and resistant hypertension.
“Lorundrostat has already shown an encouraging clinical benefit and was well-tolerated in the Target-HTN Phase II trial, which demonstrated that the inhibition of aldosterone production led to substantial blood pressure reduction among all trial participants – and particularly in the subset of individuals with obesity.”
The company is expected to announce the topline data from this trial in the first half of next year.
It is also planning a Phase III trial in a larger population of uHTN and rHTN for which enrolment is expected to begin in the second half of this year with data anticipated in mid-2025.
An open-label extension trial is also planned where patients from both studies can participate after the completion of the trials.
