Mineralys Therapeutics Announces Publication of Pivotal Phase 2 Advance-HTN Results in the New England Journal of Medicine (NEJM)
Mineralys Therapeutics (NASDAQ: MLYS) announced the publication of its pivotal Phase 2 Advance-HTN trial results in the New England Journal of Medicine (NEJM). The study evaluated lorundrostat in patients with uncontrolled or resistant hypertension.
Key findings showed that lorundrostat 50 mg achieved a 15.4 mmHg absolute reduction and a 7.9 mmHg placebo-adjusted reduction (p=0.001) in 24-hour ambulatory blood pressure at week 12. The drug demonstrated consistent efficacy across different patient groups, including those on varying baseline medications, gender, and racial demographics.
The treatment showed a favorable safety profile with modest changes in potassium, sodium, and eGFR. The results were previously presented at ACC.25 in Chicago. The company plans to present additional data from their pivotal Phase 3 Launch-HTN trial at an upcoming medical conference.
Mineralys Therapeutics (NASDAQ: MLYS) ha annunciato la pubblicazione dei risultati del suo studio cruciale di Fase 2 Advance-HTN sul New England Journal of Medicine (NEJM). Lo studio ha valutato lorundrostat in pazienti con ipertensione non controllata o resistente.
I risultati principali hanno mostrato che lorundrostat 50 mg ha ottenuto una riduzione assoluta della pressione arteriosa ambulatoriale nelle 24 ore di 15,4 mmHg e una riduzione aggiustata per placebo di 7,9 mmHg (p=0,001) alla settimana 12. Il farmaco ha dimostrato un’efficacia costante in diversi gruppi di pazienti, inclusi quelli con terapie di base differenti, genere e gruppi etnici.
Il trattamento ha evidenziato un profilo di sicurezza favorevole con variazioni contenute di potassio, sodio e eGFR. I risultati erano già stati presentati all’ACC.25 di Chicago. L’azienda prevede di presentare ulteriori dati del loro studio cruciale di Fase 3 Launch-HTN in una prossima conferenza medica.
Mineralys Therapeutics (NASDAQ: MLYS) anunció la publicación de los resultados de su ensayo pivotal de Fase 2 Advance-HTN en el New England Journal of Medicine (NEJM). El estudio evaluó lorundrostat en pacientes con hipertensión no controlada o resistente.
Los hallazgos clave mostraron que lorundrostat 50 mg logró una reducción absoluta de 15,4 mmHg y una reducción ajustada por placebo de 7,9 mmHg (p=0,001) en la presión arterial ambulatoria de 24 horas a la semana 12. El medicamento demostró eficacia constante en diferentes grupos de pacientes, incluyendo aquellos con distintos tratamientos base, género y grupos raciales.
El tratamiento mostró un perfil de seguridad favorable con cambios modestos en potasio, sodio y eGFR. Los resultados se presentaron previamente en ACC.25 en Chicago. La compañía planea presentar datos adicionales de su ensayo pivotal de Fase 3 Launch-HTN en una próxima conferencia médica.
Mineralys Therapeutics (NASDAQ: MLYS)는 그들의 중요한 2상 Advance-HTN 임상시험 결과를 New England Journal of Medicine (NEJM)에 발표했다고 밝혔습니다. 이 연구는 통제되지 않거나 저항성 고혈압 환자에서 로룬드로스타트를 평가했습니다.
주요 결과는 로룬드로스타트 50mg이 12주차 24시간 활동성 혈압에서 15.4 mmHg의 절대 감소와 7.9 mmHg의 위약 보정 감소(p=0.001)를 달성했다는 점을 보여주었습니다. 이 약물은 다양한 기저 약물 복용 환자군, 성별 및 인종 그룹에서 일관된 효능을 나타냈습니다.
치료는 칼륨, 나트륨, eGFR의 변화가 미미한 양호한 안전성 프로필을 보였습니다. 결과는 이전에 시카고에서 열린 ACC.25에서 발표되었습니다. 회사는 다가오는 의학 학회에서 3상 Launch-HTN 임상시험의 추가 데이터를 발표할 계획입니다.
Mineralys Therapeutics (NASDAQ : MLYS) a annoncé la publication des résultats de son essai pivot de phase 2 Advance-HTN dans le New England Journal of Medicine (NEJM). L’étude a évalué le lorundrostat chez des patients souffrant d’hypertension non contrôlée ou résistante.
Les résultats clés ont montré que le lorundrostat 50 mg a permis une réduction absolue de 15,4 mmHg et une réduction ajustée par rapport au placebo de 7,9 mmHg (p=0,001) de la pression artérielle ambulatoire sur 24 heures à la semaine 12. Le médicament a démontré une efficacité constante dans différents groupes de patients, incluant ceux sous divers traitements de base, selon le sexe et les origines ethniques.
Le traitement a présenté un profil de sécurité favorable avec des modifications modestes du potassium, du sodium et du DFG estimé. Les résultats avaient déjà été présentés lors de l’ACC.25 à Chicago. La société prévoit de présenter des données supplémentaires issues de leur essai pivot de phase 3 Launch-HTN lors d’une prochaine conférence médicale.
Mineralys Therapeutics (NASDAQ: MLYS) gab die Veröffentlichung der Ergebnisse seiner entscheidenden Phase-2-Studie Advance-HTN im New England Journal of Medicine (NEJM) bekannt. Die Studie untersuchte Lorundrostat bei Patienten mit unkontrolliertem oder resistentem Bluthochdruck.
Wesentliche Ergebnisse zeigten, dass Lorundrostat 50 mg eine absolute Reduktion des 24-Stunden-Ambulanzblutdrucks um 15,4 mmHg und eine placebokorrigierte Reduktion um 7,9 mmHg (p=0,001) in Woche 12 erreichte. Das Medikament zeigte eine konsistente Wirksamkeit in verschiedenen Patientengruppen, einschließlich unterschiedlicher Basismedikationen, Geschlecht und ethnischer Herkunft.
Die Behandlung wies ein günstiges Sicherheitsprofil mit moderaten Veränderungen bei Kalium, Natrium und eGFR auf. Die Ergebnisse wurden zuvor auf der ACC.25 in Chicago vorgestellt. Das Unternehmen plant, weitere Daten aus der entscheidenden Phase-3-Studie Launch-HTN auf einer bevorstehenden medizinischen Konferenz zu präsentieren.
- Strong efficacy data with significant blood pressure reduction of 15.4 mmHg absolute and 7.9 mmHg placebo-adjusted
- Publication in prestigious New England Journal of Medicine validates clinical significance
- Favorable safety and tolerability profile
- Consistent efficacy across diverse patient populations
- Novel mechanism of action addressing unmet medical need
- Phase 3 Launch-HTN trial results still pending full disclosure
- Additional long-term safety data still needed through Transform-HTN extension trial
Insights
Lorundrostat shows clinically meaningful blood pressure reduction in resistant hypertension patients by targeting the previously unaddressed aldosterone pathway.
The publication of the Advance-HTN trial in the New England Journal of Medicine represents significant validation for lorundrostat's clinical potential. The data demonstrates a
What's mechanistically important is lorundrostat's novel approach targeting aldosterone dysregulation. Current antihypertensive therapies do not directly decrease aldosterone production, despite its established role in blood pressure elevation. This represents the first potential therapeutic specifically addressing this pathway.
The trial results show consistent efficacy regardless of baseline medication count (two vs. three or more), gender, or race (white and black patients). This broad efficacy profile is particularly valuable since resistant hypertension patients typically have therapeutic options.
The safety profile shows only modest changes to potassium, sodium, and eGFR - important parameters to monitor with drugs affecting the renin-angiotensin-aldosterone system. The favorable tolerability in this trial population suggests potential for use in broader applications.
The 15.4 mmHg absolute reduction in blood pressure is particularly notable given these patients were already on optimized antihypertensive regimens. As noted in the article, even modest blood pressure reductions correlate with substantial decreases in major cardiovascular events, suggesting lorundrostat addresses a significant unmet medical need.
NEJM publication validates Mineralys' hypertension drug with positive Phase 2/3 data in a large market with high unmet need.
Mineralys Therapeutics' publication in the New England Journal of Medicine represents significant external validation of their Phase 2 clinical program for lorundrostat. This milestone enhances scientific credibility and raises the company's profile among key opinion leaders in cardiology.
The clinical data shows lorundrostat achieved statistically significant blood pressure reductions (p=0.001) in patients with uncontrolled or resistant hypertension. The efficacy across diverse patient populations suggests potential for broad market applicability if approved.
Strategically, lorundrostat appears well-positioned as a potential first-in-class aldosterone synthase inhibitor specifically targeting hypertension. The company has efficiently advanced its clinical program, completing both the pivotal Phase 2 Advance-HTN trial and Phase 3 Launch-HTN trial with positive results reported for both.
The ongoing Transform-HTN open-label extension will provide additional long-term safety data, which will strengthen the regulatory package. With two completed pivotal trials showing positive results, the company appears to be positioning for a potential regulatory submission.
The uncontrolled and resistant hypertension market represents a significant commercial opportunity with innovation in recent years. Lorundrostat addresses an established biological pathway (aldosterone dysregulation) that current therapies don't directly target, potentially carving out a distinct position in treatment algorithms.
With the NEJM publication and presentation at the American College of Cardiology's Annual Scientific Session, Mineralys is building important scientific awareness that could accelerate clinical adoption if lorundrostat reaches the market.
– Significant blood pressure reductions among patients with uncontrolled or resistant hypertension treated with lorundrostat reinforce key role of dysregulated aldosterone in disease onset and progression –
– Detailed results from the second pivotal Phase 3 Launch-HTN trial to be presented at an upcoming medical conference and published in a peer-reviewed publication –
RADNOR, Pa., April 23, 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 the New England Journal of Medicine (NEJM) published the detailed results from the Company’s pivotal Phase 2 Advance-HTN trial, the first of two pivotal trials evaluating lorundrostat in patients with uncontrolled hypertension (uHTN) or resistant hypertension (rHTN). The full manuscript is titled, “Lorundrostat Efficacy and Safety in Patients with Uncontrolled Hypertension,” and is featured in the April 23, 2025 issue of NEJM.
The key data from the publication showed that lorundrostat 50 mg demonstrated a 15.4 mmHg absolute reduction and a 7.9 mmHg placebo-adjusted reduction (p=0.001), in 24-hour ambulatory blood pressure at week 12. Lorundrostat worked equally well in those taking two baseline medications and those taking three or more, and in both men and women as well as in white and black patients. Lorundrostat demonstrated a favorable safety and tolerability profile, with modest changes in potassium, sodium and eGFR.
“The publication of our Advance-HTN trial results in the New England Journal of Medicine is a significant milestone that underscores both the strength of our clinical data and the potentially transformative nature of this new class of medicines that could help address dysregulated aldosterone, an unaddressed, key driver of hypertension,” stated Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. “Prior studies have shown that even modest reductions in systolic blood pressure can lead to a substantial decrease in the incidence of major cardiovascular events. The blood pressure reductions with lorundrostat observed in the Advance-HTN trial are particularly meaningful given the well-established correlation between elevated blood pressure, dysregulated aldosterone production and cardiovascular risk.”
“The significant blood pressure lowering with lorundrostat 50 mg in the Advance-HTN trial was seen in patients treated by specialists who were taking an optimized standardized antihypertensive regimen – those patients with true uncontrolled or resistant hypertension that desperately need new options to lower their blood pressure,” stated Luke Laffin, M.D., co-director of the Center for Blood Pressure Disorders in the Heart, Vascular & Thoracic Institute at Cleveland Clinic and the study’s lead author. “Currently available therapies to treat hypertension do not decrease aldosterone production in the body, and we know aldosterone dysregulation is a driving factor in the blood pressure elevation of many of our patients. The findings reinforce the critical role of aldosterone in the pathogenesis of hypertension and the potential of lorundrostat to address unmet medical needs facing patients with uncontrolled or treatment-resistant disease.”
The NEJM publication of the detailed Advance-HTN results follows a late-breaking presentation of the data at the American College of Cardiology’s Annual Scientific Session & Expo (ACC.25) in Chicago on March 29, 2025, and the announcement of positive topline results from both Advance-HTN and Launch-HTN earlier in March.
Mineralys plans to provide additional data from the pivotal Phase 3 Launch-HTN at an upcoming medical conference and in a peer-reviewed publication. Additionally, the ongoing Transform-HTN open-label extension trial allows subjects to continue to receive lorundrostat and obtain additional safety and efficacy data.
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 U.S. In 2020, more than 670,000 deaths in the U.S. included hypertension as a primary or contributing cause. Hypertension and related health issues resulted in an average annual economic burden of about
Less than
About Lorundrostat
Lorundrostat is a proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uHTN or rHTN, as well as CKD and OSA. 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
In a Phase 2, proof-of-concept trial (Target-HTN) in uncontrolled or resistant hypertensive subjects, once-daily lorundrostat demonstrated statistically significant and 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 Advance-HTN
The Advance-HTN trial (NCT05769608) was a randomized, double-blind, placebo-controlled Phase 2 clinical trial that evaluated the efficacy and safety of lorundrostat for the treatment of uHTN or rHTN, when used as an add-on therapy to a standardized background treatment of two or three antihypertensive medications in adult subjects. Subjects who met screening criteria had their existing hypertension medications discontinued and started on a standard regimen of an angiotensin II receptor blocker (ARB) and a diuretic, if previously on two medications, or a standard regimen of ARB, diuretic and calcium channel blocker if previously on three to five medications. Subjects who remained hypertensive despite the standardized regimen were then randomized into three cohorts and treated for twelve weeks: lorundrostat 50 mg once-daily (QD), lorundrostat 50 mg QD and an option to titrate to 100 mg QD at week four based on defined criteria, or placebo. The trial’s primary endpoint was the change in 24-hour ambulatory systolic blood pressure at week twelve from baseline for active cohorts versus placebo.
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 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, OSA, uHTN or rHTN; and the planned future clinical development of lorundrostat and the timing thereof. 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: topline results that we report are based on a preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such topline data may not accurately reflect the complete results of a clinical trial; 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; the results of our clinical trials, including the Advance-HTN and Launch-HTN trials, may not be deemed sufficient by the FDA to serve as the basis for an NDA submission or regulatory approval of lorundrostat; 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; 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
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