Mineralys Therapeutics Completes Enrollment in Explore-CKD Phase 2 Trial of Lorundrostat for the Treatment of Hypertension in Subjects with Stage 2 to 3b CKD and Albuminuria
Mineralys Therapeutics (NASDAQ: MLYS) has completed enrollment in its Explore-CKD Phase 2 trial, evaluating lorundrostat for treating hypertension in patients with Stage 2 to 3b CKD and albuminuria. The trial focuses on patients already receiving stable treatment with ACEi or ARB and SGLT2 inhibitors.
The study is designed as a randomized, double-blind, placebo-controlled, two-period, two-sequence crossover trial, testing 25 mg once-daily lorundrostat. The primary endpoint measures change in systolic blood pressure at week four compared to placebo, with an exploratory endpoint examining changes in urine albumin-to-creatinine ratio.
The company expects to announce topline data in Q2 2025. This marks Mineralys's third trial to complete enrollment, alongside Target-HTN, Advance-HTN, and the recently announced Explore-OSA trials.
Mineralys Therapeutics (NASDAQ: MLYS) ha completato il reclutamento nel suo trial di fase 2 Explore-CKD, che valuta il lorundrostat per il trattamento dell'ipertensione in pazienti con CKD di stadio 2 a 3b e albuminuria. Lo studio si concentra su pazienti già in trattamento stabile con ACEi o ARB e inibitori SGLT2.
Lo studio è progettato come un trial randomizzato, in doppio cieco, controllato con placebo, a due periodi e con crossover in due sequenze, testando 25 mg di lorundrostat una volta al giorno. L'endpoint primario misura la variazione della pressione arteriosa sistolica alla quarta settimana rispetto al placebo, con un endpoint esplorativo che esamina le variazioni del rapporto albumina-creatinina nelle urine.
L'azienda prevede di annunciare dati preliminari nel secondo trimestre del 2025. Questo segna il terzo trial di Mineralys a completare il reclutamento, insieme ai trial Target-HTN, Advance-HTN e ai recenti trial Explore-OSA.
Mineralys Therapeutics (NASDAQ: MLYS) ha completado la selección de pacientes en su ensayo de fase 2 Explore-CKD, que evalúa el lorundrostat para tratar la hipertensión en pacientes con enfermedad renal crónica (ERC) en etapa 2 a 3b y albuminuria. El ensayo se centra en pacientes que ya están recibiendo tratamiento estable con inhibidores de la enzima convertidora de angiotensina (ACEi) o bloqueadores de los receptores de angiotensina II (ARB) y SGLT2.
El estudio está diseñado como un ensayo aleatorizado, doble ciego y controlado con placebo, con dos períodos y un cruce en dos secuencias, que prueba 25 mg de lorundrostat una vez al día. El objetivo principal mide el cambio en la presión arterial sistólica en la semana cuatro en comparación con el placebo, con un objetivo exploratorio que examina los cambios en la relación de albumina a creatinina en la orina.
La empresa espera anunciar datos preliminares en el segundo trimestre de 2025. Esto marca el tercer ensayo de Mineralys en completar la selección de pacientes, junto con los ensayos Target-HTN, Advance-HTN y los recientemente anunciados ensayos Explore-OSA.
미네랄리스 테라퓨틱스 (NASDAQ: MLYS)는 CKD 2기에서 3b기 환자와 알부민뇨에서 고혈압 치료를 위해 로룬드로스타트를 평가하는 Explore-CKD 2상 시험에 대한 환자 등록을 완료했습니다. 이 시험은 ACEi 또는 ARB 및 SGLT2 억제제로 안정적인 치료를 받고 있는 환자에게 초점을 맞춥니다.
이 연구는 주 1회 25mg의 로룬드로스타트를 시험하는 무작위 이중 맹검 위약 대조, 두 기간, 두 순서 교차 연구로 설계되었습니다. 주요 평가변수는 4주차에 위약과 비교하여 수축기 혈압의 변화를 측정하며, 탐색적 평가변수는 소변의 알부민 대 크레아티닌 비율 변화에 대한 조사를 포함합니다.
회사는 2025년 2분기에 초기 데이터를 발표할 것으로 예상하고 있습니다. 이는 미네랄리스가 Target-HTN, Advance-HTN 및 최근 발표된 Explore-OSA 시험과 함께 환자 등록을 완료한 세 번째 시험입니다.
Mineralys Therapeutics (NASDAQ: MLYS) a terminé le recrutement de son essai de phase 2 Explore-CKD, qui évalue le lorundrostat pour le traitement de l'hypertension chez les patients présentant une maladie rénale chronique (MRC) de stade 2 à 3b et de l'albuminurie. L'essai se concentre sur les patients recevant déjà un traitement stable avec des inhibiteurs de l'enzyme de conversion de l'angiotensine (ACEi) ou des antagonistes des récepteurs de l'angiotensine II (ARB) et des inhibiteurs de SGLT2.
La recherche est conçue comme un essai randomisé, en double aveugle et contrôlé par placebo, avec deux périodes et un croisement en deux séquences, testant 25 mg de lorundrostat une fois par jour. Le critère principal mesure le changement de la pression artérielle systolique à la quatrième semaine par rapport au placebo, avec un critère exploratoire examinant les changements dans le rapport albumine/créatinine dans les urines.
L'entreprise prévoit d'annoncer des données préliminaires au deuxième trimestre 2025. Cela marque le troisième essai de Mineralys à compléter le recrutement, aux côtés des études Target-HTN, Advance-HTN et des essais Explore-OSA récemment annoncés.
Mineralys Therapeutics (NASDAQ: MLYS) hat die Rekrutierung in seiner Phase-2-Studie Explore-CKD abgeschlossen, die Lorundrostat zur Behandlung von Bluthochdruck bei Patienten mit Stadium 2 bis 3b CKD und Albuminurie bewertet. Die Studie konzentriert sich auf Patienten, die bereits stabil mit ACEi oder ARB und SGLT2-Inhibitoren behandelt werden.
Die Studie ist als randomisierte, doppelblinde, placebokontrollierte, zweiphasige, zwei Sequenzen-Crossover-Studie konzipiert, die 25 mg Lorundrostat einmal täglich testet. Der primäre Endpunkt misst die Veränderung des systolischen Blutdrucks in der vierten Woche im Vergleich zum Placebo, wobei ein explorativer Endpunkt die Änderungen des Verhältnisses von Albumin zu Kreatinin im Urin untersucht.
Das Unternehmen erwartet, im zweiten Quartal 2025 erste Ergebnisse bekannt zu geben. Dies ist die dritte Studie von Mineralys, die die Rekrutierung abgeschlossen hat, neben den Studien Target-HTN, Advance-HTN und den kürzlich angekündigten Explore-OSA-Studien.
- Completed enrollment in Phase 2 Explore-CKD trial on schedule
- Trial expands potential market to high-risk patients with poorly controlled hypertension
- Study addresses significant medical need in hypertensive nephropathy
- Results not expected until Q2 2025
- Still in Phase 2 stage, indicating long path to potential commercialization
Insights
The completion of enrollment in the Explore-CKD Phase 2 trial marks a pivotal development for Mineralys Therapeutics' lorundrostat program. The trial's focus on patients with Stage 2 to 3b CKD and albuminuria addresses a critical market segment, as hypertensive nephropathy remains a leading cause of renal failure in the United States.
Several strategic elements make this trial particularly noteworthy:
- The study's 2x2 crossover design is highly efficient, potentially providing robust statistical power while minimizing required patient numbers
- The trial evaluates lorundrostat as an add-on to both RAAS inhibitors and SGLT2 inhibitors, positioning it as a complementary rather than competitive therapy
- The inclusion of albuminuria as an exploratory endpoint could potentially support a broader label claim beyond blood pressure control
The timing of this enrollment completion, with data expected in Q2 2025, aligns strategically with Mineralys' other clinical programs, including Target-HTN and Advance-HTN. This coordinated approach could provide a comprehensive data package supporting lorundrostat's efficacy across multiple high-risk patient populations.
The market opportunity is substantial, given that approximately 37 million Americans have CKD, with hypertension being both a cause and complication. If successful, lorundrostat could address a significant unmet need in patients who remain poorly controlled despite current standard of care.
Continues to anticipate announcing topline data from Explore-CKD trial in Q2 2025
RADNOR, Pa., Feb. 04, 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 it has completed enrollment in the Explore-CKD Phase 2 trial evaluating the efficacy and safety of lorundrostat for the treatment of hypertension in subjects with CKD and albuminuria, despite receiving stable treatment with an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB) and an SGLT2 inhibitor.
“We are pleased to have completed enrollment in Explore-CKD and be on track to share topline data in the second quarter of 2025. This is our third trial to recently complete enrollment and we are grateful to all of the study participants, investigators, and our staff who made this possible,” stated David Rodman, MD, Chief Medical Officer of Mineralys Therapeutics. “In concert with our Target-HTN, Advance-HTN and recently announced Explore-OSA trials, Explore-CKD expands the spectrum of high-risk patients with poorly controlled hypertension who may benefit from this novel treatment modality. Poorly controlled hypertension, and hypertensive nephropathy, are a leading cause of renal failure in the United States and a strong predictor of major adverse cardiovascular events and premature death.”
The Explore-CKD trial (NCT06150924) is a randomized, double-blind, placebo controlled, two-period, two-sequence (2x2) crossover trial. This proof-of-concept trial is designed to evaluate blood pressure reduction and safety of 25 mg once daily (QD) lorundrostat added to RAAS inhibition and an SGLT2 inhibitor for the treatment of hypertension in subjects with Stage 2 to 3b CKD and albuminuria. The primary efficacy endpoint of the trial is change from baseline in systolic blood pressure at week four in the active versus placebo treatment period. An exploratory endpoint will be to evaluate change from baseline in urine albumin-to-creatinine ratio at week four in the active versus placebo treatment period.
About CKD
CKD, which is characterized by the gradual loss of kidney function, is estimated to affect more than
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 50 percent of hypertension patients achieve their blood pressure goal with currently available medications. Dysregulated aldosterone levels are a key factor in driving hypertension in approximately 25 percent of all hypertensive patients.
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), 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 an approximately
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 Company’s plan to announce top line data for Explore-CKD in the second quarter of 2025; 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, OSA, 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
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