RADNOR, Pa., Oct. 01, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and aldosterone-related adverse outcomes in comorbid conditions such as chronic kidney disease, obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced that five abstracts will be presented at the American Heart Association (AHA) Hypertension Scientific Sessions 2026, taking place October 7-11 in Arlington, VA.
Oral Presentation Details:
| Title: | Efficacy and Safety of the Selective Aldosterone Synthase Inhibitor Lorundrostat in Moderate-to-Severe Obstructive Sleep Apnea and Hypertension: Explore-OSA Randomized Crossover Trial |
| Presenter: | Reena Mehra, MD, MS, Professor of Medicine and Division Head, Pulmonary, Critical Care and Sleep Medicine, University of Washington |
| Session Time: | Thursday, October 8, 11:45 am ET |
| Session Title: | Clinical Trials and Care Delivery Innovation in Hypertension |
| Session Location: | Potomac Room |
Poster Presentation Details:
| Title: | Blood Pressure Responder Analysis in the Global Launch-HTN Trial of Lorundrostat in Uncontrolled and Resistant Hypertension |
| Presenter: | Manish Saxena, MBBS, Deputy Clinical Co-Director of Queen Mary University of London’s William Harvey Heart Centre, and Hypertension Specialist at Barts Health NHS Trust |
| Session Time: | Friday, October 9, 9:00-10:30 am ET |
| Session Title: | Poster Session 2: Clinical Trials in Hypertension and Related Morbidities |
| Poster Board: | FR461 |
| Title: | Lorundrostat Mitigates Cardiorenal Injury Independent of Blood Pressure Reduction in an L-NAME/Angiotensin II Rat Model |
| Presenter: | Jose Romero, PhD, Assistant Professor of Medicine at Harvard Medical School, and Associate Physiologist Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Brigham and Women's Hospital |
| Session Time: | Friday, October 9, 9:00-10:30 am ET |
| Session Title: | Poster Session 2: Aldosterone, Receptors and Signal Transduction |
| Poster Board: | FR401 |
| Title: | Real-World Utilization and Treatment Patterns of Spironolactone in Patients with Hypertension |
| Presenter: | Kay Sadik, PharmD, PhD, Director, Health Economics & Outcomes Research/Real-World Evidence (HEOR/RWE), Mineralys Therapeutics |
| Session Time: | Friday, October 9, 9:00-10:30 am ET |
| Session Title: | Poster Session 2: Resistant Hypertension |
| Poster Board: | FR568 |
| Title: | Adherence to Mineralocorticoid Receptor Antagonists for Uncontrolled and Treatment-Resistant Hypertension: A Targeted Literature Review and Meta-Analysis |
| Presenter: | Kay Sadik, PharmD, PhD, Director, Health Economics & Outcomes Research/Real-World Evidence (HEOR/RWE), Mineralys Therapeutics |
| Session Time: | Friday, October 9, 9:00-10:30 am ET |
| Session Title: | Poster Session 2: BP Control and Adherence to Treatment |
| Poster Board: | FR447 |
About Launch-HTN
The Launch-HTN trial (NCT06153693) was a global, randomized, double-blind, placebo-controlled Phase 3 clinical trial of adults whose blood pressure remained uncontrolled despite being on two to five antihypertensive medications. Participants were assigned to one of three groups: lorundrostat 50 mg once daily; lorundrostat 50 mg once daily with the option to increase to 100 mg at week six based on prespecified criteria; or placebo. The primary endpoint was change from baseline in systolic blood pressure at six weeks versus placebo, measured by automated office blood pressure monitoring.
About Explore-OSA
The Explore-OSA trial (NCT06785454) was a randomized, double-blind, placebo-controlled, crossover Phase 2 clinical trial. This proof-of-concept trial was designed to evaluate the efficacy, safety and tolerability of lorundrostat in overweight or obese adults with moderate-to-severe OSA and hypertension. Participants in Explore-OSA received lorundrostat 50 mg once daily and placebo in sequential treatment periods, with continuous monitoring of blood pressure during overnight polysomnography. The primary efficacy endpoint of the trial was absolute change from baseline in apnea-hypopnea index after four weeks of active treatment compared to placebo. The first secondary endpoint was automated office blood pressure, and additional endpoints were nighttime blood pressure and sleep and cardiovascular health measures.
About Hypertension
Having sustained, elevated blood pressure (or hypertension) increases the risk of heart disease, heart attack and stroke, which are leading causes of death in the United States. In 2022, more than 685,000 deaths in the United States included hypertension as a primary or contributing cause. Hypertension and related health issues resulted in an estimated annual economic burden of about $219 billion in the United States in 2019.
Less than 50% of hypertensive patients achieve their blood pressure goal with currently available medications. Dysregulated aldosterone levels are a key factor in driving hypertension in approximately 30% of all hypertensive patients.
About Lorundrostat
Lorundrostat is an investigational, proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), as well as related comorbidities, such as chronic kidney disease, obstructive sleep apnea and other diseases driven by dysregulated aldosterone. 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, has an observed half-life of 10-12 hours and demonstrated a 40-70% reduction in plasma aldosterone concentration in participants with hypertension.
Mineralys has completed six late-stage clinical trials of lorundrostat supporting its efficacy and safety profile while also validating aldosterone as an integral therapeutic target in uHTN and rHTN. The clinical program includes two pivotal, registrational trials, the Phase 3 Launch-HTN trial and Phase 2 Advance-HTN trial, which support the robust, durable and clinically meaningful reductions in systolic blood pressure by lorundrostat. Lorundrostat was well tolerated in both trials with a favorable safety profile.
About Mineralys
Mineralys Therapeutics is a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease, obstructive sleep apnea and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is an investigational, proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, X and Bluesky.
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 Mineralys’ current beliefs and expectations and include, but are not limited to, statements regarding the potential therapeutic benefits of lorundrostat. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Mineralys’ business, including, without limitation: any delays in the Food and Drug Administration’s (FDA) review of Mineralys’ accepted new drug application (NDA), including as a result of a government shutdown or reductions in agency funding or personnel; the results of Mineralys’ clinical trials, including the Launch-HTN and Advance-HTN trials, may not be deemed sufficient by the FDA to serve as the basis for regulatory approval of lorundrostat; later developments with the FDA may be inconsistent with the feedback from prior meetings, including whether the proposed pivotal program will support registration of lorundrostat following the FDA’s review of Mineralys’ NDA submission; the risk that future funding under the secured debt facility may not be available on the timeframe Mineralys expects, or at all, including as a result of its failure to meet the conditions required for such funding or failure to comply with the affirmative and negative covenants under the debt facility; Mineralys may not be able to reach agreement on the proposed termination of its license agreement with Tanabe on its expected timeframe, or at all; Mineralys’ future performance is dependent entirely on the success of lorundrostat; potential delays in the commencement, enrollment and completion of clinical trials and nonclinical studies; Mineralys’ 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; macroeconomic trends and uncertainty with regard to high interest rates, elevated inflation, tariffs and other trade policies, and the potential for a local and/or global economic recession; Mineralys’ ability to maintain undisrupted business operations due to any pandemic or future public health concerns; regulatory developments in the United States and foreign countries; Mineralys’ reliance on its exclusive license with Tanabe to provide Mineralys with intellectual property rights to develop and commercialize lorundrostat; and other risks described in Mineralys’ filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in its 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 Mineralys undertakes 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
Melyssa Weible
Elixir Health Public Relations
Email: mweible@elixirhealthpr.com
