Mineralys Therapeutics Hits Enrollment Target in Advance-HTN Trial

By Bobby Samwell • Wednesday, September 25 15:21 • Permanent Link

Mineralys Therapeutics, Inc. (NASDAQ: MLYS) has achieved its target enrollment of 261 subjects in the pivotal Advance-HTN trial, a significant milestone in the evaluation of the efficacy and safety of lorundrostat for the treatment of uncontrolled hypertension (UHTN) or resistant hypertension (RHTN). The company is on track to announce topline data in the first quarter of 2025.

The Advance-HTN trial (NCT05769608) is a randomized, double-blind, placebo-controlled phase 2 clinical trial designed to assess the efficacy and safety of lorundrostat as an add-on therapy to a standardized background treatment of two or three antihypertensive medications in adult subjects.

In a previous phase 2 trial (TARGET-HTN), lorundrostat demonstrated clinically meaningful blood pressure reduction in individuals with UHTN, as evidenced by both automated office blood pressure measurement and 24-hour ambulatory blood pressure monitoring. The drug also exhibited a 70% reduction in plasma aldosterone concentration in hypertensive subjects.

It's worth noting that less than 50% of hypertension patients currently achieve their blood pressure goal with available medications, and dysregulated aldosterone levels are a key factor in driving hypertension in approximately 25% of all hypertensive patients.

The company also announced a virtual KOL (Key Opinion Leader) event scheduled for October 30, 2024, to discuss the unmet need in hypertension and provide a review of the ongoing pivotal clinical program for lorundrostat.

Mineralys Therapeutics is focused on developing medicines to target hypertension, chronic kidney disease (CKD), and other prevalent cardiovascular diseases driven by dysregulated aldosterone. The company's initial product candidate, lorundrostat, is a highly selective aldosterone synthase inhibitor that shows promise for the treatment of cardiorenal conditions affected by dysregulated aldosterone.

Mineralys Therapeutics is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. The market has reacted to these announcements by moving the company's shares 1.5% to a price of $11.88. Check out the company's full 8-K submission here.

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