Mineralys Therapeutics Completes Enrollment in Phase 2 EXPLORE-OSA Trial of Lorundrostat in Obstructive Sleep Apnea and Hypertension
Mineralys Therapeutics (NASDAQ:MLYS) has completed enrollment in its Phase 2 EXPLORE-OSA clinical trial, evaluating lorundrostat in patients with moderate-to-severe obstructive sleep apnea (OSA) and hypertension. The company expects to report topline results in Q1 2026.
The trial aims to assess lorundrostat's effectiveness when administered at bedtime, targeting aldosterone suppression during sleep to maintain 24-hour blood pressure control. This approach addresses the significant unmet need in treating nocturnal hypertension, particularly in OSA patients where current treatments like weight loss and positive airway pressure may be insufficient.
If successful, these results will complement the company's previously positive EXPLORE-CKD trial data, potentially expanding lorundrostat's treatment scope for hypertension patients with these comorbidities.
Mineralys Therapeutics (NASDAQ:MLYS) ha completato l'arruolamento nel suo studio clinico di fase 2 EXPLORE-OSA, valutando lorundrostat in pazienti con apnea ostruttiva del sonno da moderata a grave (OSA) e ipertensione. L'azienda prevede di riportare risultati principali nel primo trimestre del 2026.
Lo studio mira a valutare l'efficacia di lorundrostat quando somministrato prima di andare a letto, mirando alla soppressione dell'aldosterone durante il sonno per mantenere il controllo della pressione sanguigna a 24 ore. Questo approccio affronta l'enorme esigenza non soddisfatta nel trattamento della ipertensione notturna, particolarmente nei pazienti OSA in cui trattamenti attuali come perdita di peso e PAP possono non essere sufficienti.
Se avrà successo, questi risultati completeranno i dati precedentemente positivi dello studio EXPLORE-CKD dell'azienda, potenzialmente espandendo l'ambito terapeutico di lorundrostat per i pazienti ipertesi con queste comorbidità.
Mineralys Therapeutics (NASDAQ:MLYS) ha completado la inscripción en su ensayo clínico de fase 2 EXPLORE-OSA, evaluando lorundrostat en pacientes con apnea obstructiva del sueño moderada a severa (OSA) e hipertensión. La compañía espera reportar resultados preliminares en el primer trimestre de 2026.
El ensayo tiene como objetivo evaluar la efectividad de lorundrostat cuando se administra a la hora de acostarse, apuntando a la supresión de la aldosterona durante el sueño para mantener el control de la presión arterial durante 24 horas. Este enfoque aborda la importante necesidad no satisfecha en el tratamiento de la hipertensión nocturna, particularmente en pacientes con OSA, donde tratamientos actuales como la pérdida de peso y la presión positiva continua pueden ser insuficientes.
Si tiene éxito, estos resultados complementarán los datos positivos previos del ensayo EXPLORE-CKD de la empresa, potencialmente ampliando el alcance del tratamiento de lorundrostat para pacientes con hipertensión y estas comorbilidades.
Mineralys Therapeutics (NASDAQ:MLYS)는 중등도에서 중증의 수면무호흡증(OSA)과 고혈압이 있는 환자에서 로룬드로스타트를 평가하는 2상 EXPLORE-OSA 임상 시험의 등록을 완료했습니다. 회사는 2026년 1분기에 주요 결과를 발표할 예정입니다.
이 시험은 취침 시에 투여될 때 로룬드로스타트의 효과를 평가하는 것을 목표로 하며, 수면 중 알도스테론 억제를 통해 24시간 혈압 조절을 유지하는 것을 목표로 합니다. 이 접근 방식은 특히 현재의 체중 감소 및 양압 치료와 같은 치료가 충분하지 않을 수 있는 OSA 환자에서 야간 고혈압 치료의 중요한 미충족 수요를 해결합니다.
성공한다면, 이 결과는 회사가 이전에 긍정적이었던 EXPLORE-CKD 시험 데이터를 보완하고, 이러한 동반 질환이 있는 고혈압 환자에 대한 로룬드로스타트의 치료 범위를 확장할 가능성을 제시할 수 있습니다.
Mineralys Therapeutics (NASDAQ:MLYS) a terminé le recrutement de son essai clinique de phase 2 EXPLORE-OSA, évaluant le lorundrostat chez des patients atteints d’apnée du sommeil obstructive modérée à sévère (OSA) et d’hypertension. La société prévoit de publier les résultats préliminaires au cours du premier trimestre 2026.
L’essai vise à évaluer l’efficacité du lorundrostat lorsqu’il est administré au coucher, en visant la suppression de l’aldostérone pendant le sommeil afin de maintenir le contrôle de la pression artérielle sur 24 heures. Cette approche répond au besoin non satisfait important dans le traitement de l’hypertension nocturne, en particulier chez les patients OSA où les traitements actuels tels que la perte de poids et la pression positive continue peuvent être insuffisants.
En cas de succès, ces résultats compléteront les données positives antérieures de l’essai EXPLORE-CKD de la société, pouvant potentiellement élargir le champ thérapeutique du lorundrostat pour les patients hypertendus présentant ces comorbidités.
Mineralys Therapeutics (NASDAQ:MLYS) hat die Rekrutierung in seiner Phase-2-EXPLORE-OSA-Studie abgeschlossen, die Lorundrostat bei Patienten mit mittlerer bis schwerer obstruktiver Schlafapnoe (OSA) und Hypertonie bewertet. Das Unternehmen erwartet, erstes Endergebnis im Q1 2026 zu berichten.
Die Studie zielt darauf ab, die Wirksamkeit von Lorundrostat zu bewerten, wenn es vor dem Schlafengehen verabreicht wird, mit dem Ziel, die Aldosteron-Suppression während des Schlafs zu erreichen, um die 24-Stunden-Blutdruckkontrolle aufrechtzuerhalten. Dieser Ansatz adressiert den erheblichen ungedeckten Bedarf bei der Behandlung von nächtlicher Hypertonie, insbesondere bei OSA-Patienten, bei denen derzeitige Behandlungen wie Gewichtsverlust und kontinuierlicher positiver Atemwegsdruck möglicherweise unzureichend sind.
Wenn erfolgreich, würden diese Ergebnisse die zuvor positiven EXPLORE-CKD-Studienergebnisse des Unternehmens ergänzen und potenziell den Behandlungsumfang von Lorundrostat für Hypertensionspatienten mit diesen Komorbiditäten erweitern.
Mineralys Therapeutics (NASDAQ:MLYS) أتمت التسجيل في تجربتها السريرية من المرحلة الثانية EXPLORE-OSA، التي تقيم lorundrostat لدى مرضى انقطـاع النفس النومي الانسدادي من متوسط إلى شديد (OSA) وارتفاع ضغط الدم. تتوقع الشركة إعلان نتائج أولية في الربع الأول من 2026.
تهدف التجربة إلى تقييم فعالية lorundrostat عند إعطائه قبل النوم، مع استهداف كبت الألدوستيرون أثناء النوم للحفاظ على السيطرة على ضغط الدم على مدار 24 ساعة. يعالج هذا النهج الاحتياج غير الملبى الكبير في علاج ارتفاع ضغط الدم الليلي، خصوصًا لدى مرضى OSA حيث قد تكون العلاجات الحالية مثل فقدان الوزن والضغط الهوائي الإيجابي المستمر غير كافية.
إذا نجحت، ستكمل هذه النتائج البيانات السابقة الإيجابية لـ EXPLORE-CKD للشركة، مما قد يوسع نطاق علاج lorundrostat لمرضى ارتفاع ضغط الدم المصابين بهذه المتلازمات المصاحبة.
Mineralys Therapeutics (NASDAQ:MLYS) 已完成其二期 EXPLORE-OSA 临床试验的招募，评估 lorundrostat 在 中度至重度阻塞性睡眠呼吸暂停综合征（OSA）和高血压 患者中的效果。公司预计在 2026 年第一季度公布初步结果。
该试验旨在评估 lorundrostat 在就寝前给药时的有效性，目标是在睡眠中抑制醛固酮以保持 24 小时血压控制。这一方法解决了夜间高血压治疗的显著未满足需求，尤其是在 OSA 患者中，当前的治疗如减重和持续气道正压治疗可能不足。
如取得成功，这些结果将补充公司此前 EXPLORE-CKD 试验的积极数据，可能扩展 lorundrostat 针对具有这些合并症的高血压患者的治疗范围。
- Trial enrollment completion represents a significant clinical milestone
- Potential to address underserved market in nocturnal hypertension and OSA
- Previous positive results from EXPLORE-CKD trial suggest promising outlook
- Novel bedtime dosing approach targets specific biological mechanism
- Results not expected until Q1 2026, indicating extended timeline to potential commercialization
- No guarantee of positive trial outcomes
- Faces competition from existing treatments like positive airway pressure devices
Insights
Mineralys completes enrollment for lorundrostat Phase 2 trial in OSA patients; results expected Q1 2026, potentially expanding treatment indications.
Mineralys Therapeutics has achieved a key clinical milestone by completing enrollment in its Phase 2 EXPLORE-OSA trial, investigating lorundrostat for patients with both obstructive sleep apnea (OSA) and hypertension. This represents meaningful progress in their clinical development timeline, with topline results expected in Q1 2026.
The trial focuses on a significant unmet medical need at the intersection of two related conditions. Current OSA treatments (weight loss and CPAP devices) often deliver suboptimal outcomes, particularly in controlling nocturnal hypertension. Lorundrostat's bedtime dosing strategy targets aldosterone production during sleep—a clever mechanistic approach that addresses the biological link between airway obstruction and blood pressure spikes.
This study builds on Mineralys' development strategy following their previously reported positive EXPLORE-CKD trial results. The company is systematically targeting hypertension patients with specific comorbidities where dysregulated aldosterone plays a role. Success in both the CKD and OSA populations would significantly expand lorundrostat's potential market by addressing specialized patient segments with limited treatment options.
The Q1 2026 timeline for results gives us a clear development roadmap. For a clinical-stage company like Mineralys, hitting these enrollment targets on schedule demonstrates operational execution capacity—an important consideration alongside the science itself.
~ Topline results from the EXPLORE-OSA trial are anticipated in 1Q 2026 ~
RADNOR, Pa., Sept. 30, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced that it has completed enrollment in its Phase 2 EXPLORE-OSA trial of lorundrostat in participants with moderate-to-severe OSA and hypertension.
“Obstructive sleep apnea and high blood pressure are biologically linked, with blood pressure rising during upper airway obstruction during sleep. In dosing lorundrostat at bedtime, we believe it will suppress the majority of aldosterone produced during sleep while maintaining 24-hour blood pressure control,” said David Rodman, MD, Chief Medical Officer of Mineralys Therapeutics. “Episodes of nocturnal hypertension are underdiagnosed and lack an effective treatment. This is particularly concerning for patients that also suffer from comorbid OSA, where available treatments – which are limited to weight loss and the use of positive airway pressure – may not be sufficiently effective in minimizing the impact on major adverse clinical outcomes. Consequently, there remains a significant unmet need for more effective and targeted treatment options for patients suffering with OSA and hypertension.”
Now that participant enrollment is complete, the Company anticipates analyzing and reporting top-line results of the EXPLORE-OSA trial in the first quarter of 2026. If the trial is successful, the Company believes these data will complement the previously announced positive topline data from its EXPLORE-CKD trial. Demonstrating positive results in these two patient populations would continue to expand the opportunity for lorundrostat in treating hypertension patients with these comorbidities.
About EXPLORE-OSA
The EXPLORE-OSA trial (NCT06785454) is a randomized, Phase 2 double-blind, placebo-controlled, crossover 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 obstructive sleep apnea (OSA) and hypertension. Participants in EXPLORE-OSA will receive 50 mg of oral, once daily (QD) lorundrostat and placebo in sequential treatment periods, with continuous monitoring of blood pressure during overnight polysomnography. The primary efficacy endpoint of the trial is absolute change from baseline in apnea-hypopnea index (AHI) after four weeks of active treatment compared to placebo. Key secondary endpoints include changes in blood pressure, nighttime blood pressure and additional sleep and cardiovascular health measures.
About Obstructive Sleep Apnea
Obstructive sleep apnea (OSA) is characterized by repetitive overnight hypoxic episodes and subsequent sleep fragmentation due to a complete or partial collapse of the upper airway. Moderate OSA is defined as having between 15 and 30 breathing pauses (apnea or hypopnea events) per hour of sleep, while severe OSA indicates more than 30 breathing pauses per hour. OSA impacts almost one billion people globally, including 425 million moderate-to-severe cases. Around
Between 30
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
Less than
About Lorundrostat
Lorundrostat is a proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), as well as chronic kidney disease (CKD) and obstructive sleep apnea (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 a 40
About Mineralys
Mineralys Therapeutics is 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. 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, Twitter 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 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 submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA); the anticipated timing of NDA submission and a potential pre-NDA meeting with the 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 participants 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: 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; macroeconomic trends and uncertainty with regard to high interest rates, elevated inflation, tariffs, and the potential for a local and/or global economic recession; 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
Melyssa Weible
Elixir Health Public Relations
Email: mweible@elixirhealthpr.com
FAQ
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