STOCK TITAN

Mineralys Therapeutics Announces Data from the Phase 2 Advance-HTN Trial of Lorundrosat for the Treatment of Hypertension Has Been Accepted as a Late-Breaking Presentation at the 2025 American College of Cardiology’s Annual Scientific Session & Expo

Rhea-AI Impact
(Neutral)
Rhea-AI Sentiment
(Negative)

Mineralys Therapeutics (Nasdaq: MLYS) has announced that data from their Phase 2 Advance-HTN trial of lorundrostat will be presented as a late-breaking presentation at the American College of Cardiology's Annual Scientific Session & Expo (ACC.25) in Chicago, March 29-31, 2025.

The trial evaluates the efficacy and safety of lorundrostat for treating uncontrolled hypertension (uHTN) and resistant hypertension (rHTN). Lorundrostat is being developed as part of the company's focus on medicines targeting hypertension, chronic kidney disease (CKD), obstructive sleep apnea and other diseases driven by dysregulated aldosterone.

Mineralys Therapeutics (Nasdaq: MLYS) ha annunciato che i dati del loro trial di Fase 2 Advance-HTN su lorundrostat saranno presentati come presentazione tardiva al Congresso Scientifico Annuale & Expo dell'American College of Cardiology (ACC.25) a Chicago, dal 29 al 31 marzo 2025.

Il trial valuta l'efficacia e la sicurezza di lorundrostat nel trattamento dell'ipertensione non controllata (uHTN) e dell'ipertensione resistente (rHTN). Lorundrostat è in fase di sviluppo come parte del focus dell'azienda su farmaci mirati all'ipertensione, alla malattia renale cronica (CKD), all'apnea ostruttiva del sonno e ad altre malattie causate da un'aldosterone disregolato.

Mineralys Therapeutics (Nasdaq: MLYS) ha anunciado que los datos de su ensayo de Fase 2 Advance-HTN sobre lorundrostat se presentarán como una presentación de última hora en el Congreso Científico Anual & Expo del American College of Cardiology (ACC.25) en Chicago, del 29 al 31 de marzo de 2025.

El ensayo evalúa la eficacia y seguridad de lorundrostat para tratar la hipertensión no controlada (uHTN) y la hipertensión resistente (rHTN). Lorundrostat se está desarrollando como parte del enfoque de la empresa en medicamentos dirigidos a la hipertensión, la enfermedad renal crónica (CKD), la apnea obstructiva del sueño y otras enfermedades impulsadas por la aldosterona desregulada.

Mineralys Therapeutics (Nasdaq: MLYS)는 lorundrostat의 2상 Advance-HTN 시험에서 얻은 데이터를 미국심장학회 연례 과학 세션 및 엑스포 (ACC.25)에서 발표할 예정이라고 발표했습니다. 이 행사는 2025년 3월 29일부터 31일까지 시카고에서 열립니다.

이 시험은 lorundrostat의 조절되지 않는 고혈압 (uHTN)저항성 고혈압 (rHTN) 치료에 대한 효능과 안전성을 평가합니다. Lorundrostat는 고혈압, 만성 신장 질환 (CKD), 폐쇄성 수면 무호흡증 및 기타 알도스테론 조절 장애에 의해 유발되는 질병을 목표로 하는 약물에 대한 회사의 집중의 일환으로 개발되고 있습니다.

Mineralys Therapeutics (Nasdaq: MLYS) a annoncé que les données de leur essai de Phase 2 Advance-HTN sur lorundrostat seront présentées lors d'une présentation tardive au Congrès Scientifique Annuel & Expo de l'American College of Cardiology (ACC.25) à Chicago, du 29 au 31 mars 2025.

L'essai évalue l'efficacité et la sécurité de lorundrostat pour traiter l'hypertension non contrôlée (uHTN) et l'hypertension résistante (rHTN). Lorundrostat est en cours de développement dans le cadre de l'orientation de l'entreprise vers des médicaments ciblant l'hypertension, la maladie rénale chronique (CKD), l'apnée obstructive du sommeil et d'autres maladies causées par une aldostérone dysrégulée.

Mineralys Therapeutics (Nasdaq: MLYS) hat angekündigt, dass Daten aus ihrer Phase-2-Studie Advance-HTN zu lorundrostat als späte Präsentation auf dem Jahreskongress & Expo des American College of Cardiology (ACC.25) in Chicago vom 29. bis 31. März 2025 vorgestellt werden.

Die Studie bewertet die Wirksamkeit und Sicherheit von lorundrostat zur Behandlung von unkontrollierter Hypertonie (uHTN) und resistenter Hypertonie (rHTN). Lorundrostat wird als Teil des Unternehmensfokus auf Medikamente zur Behandlung von Hypertonie, chronischer Nierenerkrankung (CKD), obstruktiver Schlafapnoe und anderen durch dysreguliertes Aldosteron bedingten Erkrankungen entwickelt.

Positive
  • None.
Negative
  • None.

RADNOR, Pa., March 17, 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 and other diseases driven by dysregulated aldosterone, today announced that data from the Phase 2 Advance-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 American College of Cardiology’s Annual Scientific Session & Expo (ACC.25), which is being held in Chicago on March 29-31, 2025.

Details for the Late-Breaking Clinical Trial Abstract:

  
Abstract Title:Efficacy of Lorundrostat, A Novel Aldosterone Synthase Inhibitor, In Patients With Uncontrolled Hypertension On A Standardized Antihypertensive Medication Regimen
Presenter:Luke Laffin, Advance-HTN Investigators, Cleveland Clinic Foundation
Session Date/Time:Saturday, March 29th from 1:45 p.m. to 1:55 p.m. CT
Session Title:Late-Breaking Clinical Trials III (Session 104)
Session Location:Main Tent, North Hall B
  

About Lorundrostat

Lorundrostat is a proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uncontrolled hypertension (uHTN) and resistant hypertension (rHTN) as well as chronic kidney disease (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 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, rHTN or OSA in patients with hypertension; 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 significance of Mineralys Therapeutics' Phase 2 Advance-HTN trial data being accepted at ACC.25?

The acceptance as a late-breaking presentation at ACC.25 indicates the potential significance of lorundrostat's trial results in treating uncontrolled and resistant hypertension.

When and where will MLYS present the Advance-HTN trial results?

The results will be presented at ACC.25 in Chicago during March 29-31, 2025.

What conditions is Mineralys Therapeutics' lorundrostat targeting in the Phase 2 trial?

Lorundrostat is being evaluated for uncontrolled hypertension (uHTN) and resistant hypertension (rHTN).

What therapeutic areas is MLYS focusing on besides hypertension?

MLYS is developing treatments for chronic kidney disease (CKD), obstructive sleep apnea, and other diseases driven by dysregulated aldosterone.
Mineralys Therapeutics, Inc.

NASDAQ:MLYS

MLYS Rankings

MLYS Latest News

MLYS Stock Data

862.85M
55.77M
2%
87.07%
4.04%
Biotechnology
Pharmaceutical Preparations
Link
United States
RADNOR