Mineralys Therapeutics Announces Late-Breaking Presentation of Phase 3 Launch-HTN Trial at 34th European Meeting on Hypertension and Cardiovascular Protection

Rhea-AI Summary

Mineralys Therapeutics (NASDAQ: MLYS) announced that data from its pivotal Phase 3 Launch-HTN trial for lorundrostat will be presented at the 34th European Meeting on Hypertension and Cardiovascular Protection (ESH 2025) in Milan. The presentation, scheduled for May 24th, 2025, will showcase results for treating uncontrolled hypertension (uHTN) and resistant hypertension (rHTN).

Lorundrostat is an oral, selective aldosterone synthase inhibitor designed to reduce aldosterone levels by inhibiting CYP11B2. The drug shows 374-fold selectivity for aldosterone-synthase inhibition and has demonstrated approximately 70% reduction in plasma aldosterone concentration. Previous Phase 2 trials showed meaningful blood pressure reduction, with observed adverse events including increased serum potassium, decreased glomerular filtration rate, and urinary tract infection.

Insights

Clinical Development Expert

Mineralys will present pivotal Phase 3 data for its hypertension drug lorundrostat at a major European conference - a critical milestone for approval prospects.

This announcement marks a significant milestone in Mineralys Therapeutics' drug development journey. The upcoming presentation of Phase 3 data for lorundrostat at the European Meeting on Hypertension suggests the trial has completed with analyzable results - a crucial step toward potential regulatory submission. As an aldosterone synthase inhibitor with 374-fold selectivity for CYP11B2, lorundrostat represents a mechanistically differentiated approach to treating hypertension.

The presentation's designation as a late-breaking clinical trial is particularly noteworthy, as these slots are typically reserved for high-impact, novel findings. This positioning at a prestigious European cardiology meeting suggests the data may be clinically meaningful. The previous Phase 2 data showed lorundrostat achieved clinically significant blood pressure reductions in both office measurements and 24-hour ambulatory monitoring.

The safety profile from Phase 2 showed manageable issues typical of this drug class: modest increases in serum potassium, decreased eGFR, and one possibly drug-related case of hyponatremia. The Phase 3 data will be critical in confirming whether these safety signals remain manageable at scale. For patients with uncontrolled or resistant hypertension, who have limited effective treatment options, lorundrostat could potentially address a substantial unmet need if the Phase 3 data confirms efficacy while maintaining an acceptable safety profile.

RADNOR, Pa., May 20, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced that data from the pivotal Phase 3 Launch-HTN trial evaluating the efficacy and safety of lorundrostat for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN) will be presented in a late-breaking clinical trials session at the 34th European Meeting on Hypertension and Cardiovascular Protection (ESH 2025), which will be held in Milan at the MICO Congress Center, on May 23-26, 2025.

Details for the Late-Breaking Clinical Trial Abstract:

Abstract Title:	Phase 3 Efficacy and Safety of a Novel Aldosterone Synthase Inhibitor in Patients with Uncontrolled and Treatment-Resistant Hypertension: Launch-HTN Study
Presenter:	Manish Saxena MBBS, Hypertension Specialist from Barts Health NHS Trust and William Harvey Heart Centre, Queen Mary University London
Session Date/Time:	Saturday, May 24th, at 10:00-11:00am CEST
Session Title:	Late Breakers 1
Session Location:	Aqua 1

About Lorundrostat

Lorundrostat is a proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uHTN and rHTN as well as CKD. Lorundrostat was designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for its production. Lorundrostat has 374-fold selectivity for aldosterone-synthase inhibition versus cortisol-synthase inhibition in vitro, an observed half-life of 10-12 hours and demonstrated approximately a 70% reduction in plasma aldosterone concentration in hypertensive subjects.

In a Phase 2, proof-of-concept trial (Target-HTN) in uncontrolled or resistant hypertensive subjects, once-daily lorundrostat demonstrated clinically meaningful blood pressure reduction in both automated office blood pressure measurement and 24-hour ambulatory blood pressure monitoring. Adverse events observed were a modest increase in serum potassium, decrease in estimated glomerular filtration rate, urinary tract infection and hypertension with one serious adverse event possibly related to study drug being hyponatremia.

About Mineralys

Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, CKD, OSA and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor that Mineralys Therapeutics is developing for the treatment of cardiorenal conditions affected by dysregulated aldosterone, including hypertension, CKD and OSA. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn and Twitter.

Forward Looking Statements

Mineralys Therapeutics cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, statements regarding: the potential therapeutic benefits of lorundrostat; the Company’s expectation that aldosterone synthase inhibitors with an SGLT2 inhibitor may provide additive clinical benefits to patients; the Company’s expectation that Advance-HTN and Launch-HTN may serve as pivotal trials in any submission of a new drug application (NDA) to the United States Food and Drug Administration (FDA); the Company’s ability to evaluate lorundrostat as a potential treatment for CKD, uHTN or rHTN; the planned future clinical development of lorundrostat and the timing thereof; and the expected timing of commencement and enrollment of patients in clinical trials and topline results from clinical trials. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: our future performance is dependent entirely on the success of lorundrostat; potential delays in the commencement, enrollment and completion of clinical trials and nonclinical studies; later developments with the FDA may be inconsistent with the feedback from the completed end of Phase 2 meeting, including whether the proposed pivotal program will support registration of lorundrostat which is a review issue with the FDA upon submission of an NDA; our dependence on third parties in connection with manufacturing, research and clinical and nonclinical testing; unexpected adverse side effects or inadequate efficacy of lorundrostat that may limit its development, regulatory approval and/or commercialization; unfavorable results from clinical trials and nonclinical studies; results of prior clinical trials and studies of lorundrostat are not necessarily predictive of future results; our ability to maintain undisrupted business operations due to any pandemic or future public health concerns; regulatory developments in the United States and foreign countries; our reliance on our exclusive license with Mitsubishi Tanabe Pharma to provide us with intellectual property rights to develop and commercialize lorundrostat; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Contact:
Investor Relations
investorrelations@mineralystx.com

Media Relations
Tom Weible
Elixir Health Public Relations
Phone: (1) 515-707-9678
Email: tweible@elixirhealthpr.com

FAQ

What is the purpose of Mineralys Therapeutics' Phase 3 Launch-HTN trial for MLYS stock?

The Phase 3 Launch-HTN trial evaluates the efficacy and safety of lorundrostat for treating uncontrolled hypertension (uHTN) and resistant hypertension (rHTN).

When and where will MLYS present its Phase 3 Launch-HTN trial results?

The results will be presented on May 24th, 2025, at 10:00 AM CEST during the 34th European Meeting on Hypertension and Cardiovascular Protection in Milan, Italy.

What are the key features of Mineralys Therapeutics' lorundrostat drug?

Lorundrostat is an oral aldosterone synthase inhibitor with 374-fold selectivity, 10-12 hour half-life, and has shown 70% reduction in plasma aldosterone concentration in hypertensive subjects.

What were the results from lorundrostat's Phase 2 Target-HTN trial?

The Phase 2 trial demonstrated clinically meaningful blood pressure reduction in both automated office and 24-hour ambulatory monitoring, with some adverse events including increased serum potassium and decreased glomerular filtration rate.