Mineralys Therapeutics Announces Phase 2 Clinical Trial of Lorundrostat for Obstructive Sleep Apnea in Patients with Hypertension
Mineralys Therapeutics (NASDAQ: MLYS) has received FDA clearance for its IND Application to conduct a Phase 2 clinical trial evaluating lorundrostat in treating patients with moderate-to-severe obstructive sleep apnea (OSA) and hypertension. The trial is set to begin in Q1 2025.
The planned study will be placebo-controlled and crossover-designed, testing lorundrostat 50mg once daily in approximately 40 subjects across 40 sites. Participants must be at least 18 years old with a BMI ≥27 kg/m2. The trial aims to validate lorundrostat's ability to reduce upper airway obstruction and nocturnal hypertension, with the primary outcome measuring changes in apnea-hypopnea episodes.
OSA represents Mineralys' third targeted indication for lorundrostat, affecting an estimated 54 million people in the U.S., including 30-50% of adults with hypertension. The company confirms sufficient funding through Q1 2026 to support planned clinical trials and operations.
Mineralys Therapeutics (NASDAQ: MLYS) ha ricevuto l'approvazione della FDA per la sua domanda IND per condurre uno studio clinico di Fase 2 volto a valutare il lorundrostat nel trattamento di pazienti con apnea ostruttiva del sonno (OSA) da moderata a grave e ipertensione. Il trial inizierà nel primo trimestre del 2025.
Lo studio pianificato sarà controllato con placebo e progettato come crossover, testando lorundrostat 50mg una volta al giorno su circa 40 soggetti distribuiti in 40 siti. I partecipanti devono avere almeno 18 anni con un BMI ≥27 kg/m2. Il trial mira a convalidare la capacità del lorundrostat di ridurre l'ostruzione delle vie aeree superiori e l'ipertensione notturna, con l'obiettivo primario che misura le variazioni negli episodi di apnea-ipopnea.
L'OSA rappresenta la terza indicazione mirata da Mineralys per il lorundrostat, che colpisce circa 54 milioni di persone negli Stati Uniti, inclusi il 30-50% degli adulti affetti da ipertensione. L'azienda conferma di avere finanziamenti sufficienti fino al primo trimestre del 2026 per supportare gli studi clinici e le operazioni pianificate.
Mineralys Therapeutics (NASDAQ: MLYS) ha recibido la aprobación de la FDA para su solicitud IND para llevar a cabo un ensayo clínico de Fase 2 que evalúa el lorundrostat en el tratamiento de pacientes con apnea obstructiva del sueño (OSA) de moderada a grave e hipertensión. El ensayo se iniciará en el primer trimestre de 2025.
El estudio planificado será controlado con placebo y diseñado como crossover, probando lorundrostat 50mg una vez al día en aproximadamente 40 sujetos distribuidos en 40 sitios. Los participantes deben tener al menos 18 años con un IMC ≥27 kg/m2. El ensayo tiene como objetivo validar la capacidad del lorundrostat para reducir la obstrucción de las vías respiratorias superiores y la hipertensión nocturna, con el resultado primario que mide los cambios en los episodios de apnea-hipopnea.
La OSA representa la tercera indicación objetivo para el lorundrostat de Mineralys, afectando a un estimado de 54 millones de personas en los EE. UU., incluidos el 30-50% de los adultos con hipertensión. La compañía confirma contar con financiamiento suficiente hasta el primer trimestre de 2026 para respaldar los ensayos clínicos y las operaciones planificadas.
미네랄리스 테라퓨틱스 (NASDAQ: MLYS)는 중등도에서 중증의 폐쇄성 수면무호흡증 (OSA) 및 고혈압 치료에 대한 로룬드로스타트를 평가하기 위한 2상 임상 시험을 실시하기 위해 FDA의 IND 신청 승인을 받았습니다. 이 시험은 2025년 1분기에 시작될 예정입니다.
계획된 연구는 플라시보 대조군으로 진행되며 크로스오버 디자인으로, 약 40명의 피험자를 대상으로 하루 1회 50mg의 로룬드로스타트를 시험할 것입니다. 참가자는 최소 18세 이상이며 BMI ≥27 kg/m2이어야 합니다. 이 시험은 로룬드로스타트의 기도 상부 차단 및 야간 고혈압 감소 능력을 검증하는 것을 목표로 하며, 주요 결과는 무호흡-저호흡 에피소드의 변화를 측정합니다.
OSA는 미네랄리스의 로룬드로스타트에 대한 세 번째 목표 적응증으로, 미국에서 약 5,400만 명이 영향을 받고 있으며, 고혈압이 있는 성인 중 30-50%가 포함됩니다. 이 회사는 계획된 임상 시험 및 운영을 지원하기 위해 2026년 1분기까지 충분한 자금이 확보되었다고 확인합니다.
Mineralys Therapeutics (NASDAQ: MLYS) a reçu l'approbation de la FDA pour sa demande IND afin de réaliser un essai clinique de Phase 2 évaluant le lorundrostat dans le traitement des patients atteints d'apnée obstructive du sommeil (OSA) modérée à sévère et d'hypertension. L'essai doit commencer au premier trimestre 2025.
L'étude prévue sera contrôlée par placebo et conçue en croix, testant le lorundrostat 50mg une fois par jour chez environ 40 sujets répartis sur 40 sites. Les participants doivent avoir au moins 18 ans avec un IMC ≥27 kg/m2. L'essai vise à valider la capacité du lorundrostat à réduire l'obstruction des voies aériennes supérieures et l'hypertension nocturne, avec le critère principal mesurant les changements dans les épisodes d'apnée-hypopnée.
L'OSA représente la troisième indication ciblée pour le lorundrostat de Mineralys, affectant environ 54 millions de personnes aux États-Unis, dont 30 à 50 % des adultes souffrant d'hypertension. L'entreprise confirme avoir suffisamment de financements jusqu'au premier trimestre 2026 pour soutenir les essais cliniques et les opérations prévues.
Mineralys Therapeutics (NASDAQ: MLYS) hat die Genehmigung der FDA für seinen IND-Antrag erhalten, um eine klinische Studie der Phase 2 zur Bewertung von Lorundrostat bei der Behandlung von Patienten mit moderater bis schwerer obstruktiver Schlafapnoe (OSA) und Bluthochdruck durchzuführen. Die Studie soll im ersten Quartal 2025 beginnen.
Die geplante Studie wird placebokontrolliert und im Cross-over-Design durchgeführt, wobei Lorundrostat 50mg einmal täglich an etwa 40 Probanden an 40 Standorten getestet wird. Die Teilnehmer müssen mindestens 18 Jahre alt sein und einen BMI von ≥27 kg/m2 haben. Das Ziel der Studie ist es, die Fähigkeit von Lorundrostat zur Reduzierung von oberen Atemwegsobstruktionen und nächtlichem Bluthochdruck zu validieren, wobei als primäres Ergebnis die Veränderungen in den Apnoe-Hypopnoe-Episoden gemessen werden.
OSA stellt die dritte gezielte Indikation für Lorundrostat von Mineralys dar, die schätzungsweise 54 Millionen Menschen in den USA betrifft, darunter 30-50% der Erwachsenen mit Bluthochdruck. Das Unternehmen bestätigt, dass es bis ins erste Quartal 2026 über ausreichende Mittel zur Unterstützung geplanter klinischer Studien und Betriebe verfügt.
- FDA clearance received for Phase 2 clinical trial IND Application
- Expansion into third indication (OSA) increases market potential
- Large addressable market of 54 million OSA patients in the U.S.
- Sufficient cash runway through Q1 2026
- Trial not starting until Q1 2025
- Small trial size of only 40 subjects
Insights
The IND clearance for lorundrostat's Phase 2 trial in OSA represents a strategic expansion into a substantial market opportunity. With 54 million OSA patients in the U.S. and 30-50% of hypertensive adults affected, this dual-indication approach could significantly broaden the drug's commercial potential.
The trial design is particularly noteworthy - a placebo-controlled crossover study with 50mg once-daily dosing targeting 40 subjects across 40 sites. This approach maximizes statistical power while minimizing required patient numbers. The focus on evening dosing aligns with the nocturnal nature of OSA symptoms.
The study's emphasis on both airway obstruction and nocturnal hypertension endpoints could position lorundrostat as a first-in-class therapy addressing multiple aspects of OSA pathophysiology through aldosterone suppression. The inclusion criteria of BMI ≥27 kg/m² appropriately targets the demographic most affected by OSA.
The expansion into OSA treatment significantly enhances MLYS's market potential. With a current market cap of
The trial's efficient design with 40 sites suggests strong infrastructure support while maintaining cost-effectiveness. Success in this indication could position lorundrostat as a unique therapeutic option in a largely device-dominated market (CPAP). The dual mechanism addressing both OSA and hypertension could support premium pricing and broader insurance coverage.
The company's measured approach to clinical development and cash management, combined with the substantial addressable market in OSA-hypertension comorbidity, presents an attractive risk-reward profile for investors focused on emerging biotech opportunities.
– Estimated 54 million people suffer from obstructive sleep apnea in the U.S. including 30
– Obstructive sleep apnea represents Mineralys’ third precision, targeted indication for lorundrostat, further expanding its market potential in aldosterone-driven diseases –
– Initiation of the trial anticipated in the first quarter of 2025 –
RADNOR, Pa., Jan. 08, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases driven by dysregulated aldosterone, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) Application for a Phase 2 clinical trial to evaluate the effect of lorundrostat in the treatment of subjects with moderate-to-severe obstructive sleep apnea (OSA) and hypertension. The Company anticipates initiating the trial in the first quarter of 2025.
“We are pleased to announce the OSA clinical development program for lorundrostat. This program aligns with our strategy to develop lorundrostat in conditions driven by dysregulated aldosterone, with poor cardiovascular outcomes and few treatment options,” stated Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. “We believe suppression of aldosterone production by lorundrostat has the potential to reduce the nocturnal hypertension driving adverse cardiovascular outcomes. In addition, lorundrostat is anticipated to reduce the severity of upper airway obstruction and associated OSA symptoms such as daytime sleepiness and cognitive impairment.”
“Obstructive sleep apnea carries significant physiological and psychological impacts on health. Along with trouble sleeping, excessive daytime sleepiness and snoring from repetitive upper airway closure, patients frequently experience significant surges in blood pressure overnight contributing to the daytime hypertension that most are struggling to control,” stated Reena Mehra, MD, MS, a sleep disorders researcher and physician and new member of the Mineralys Scientific Advisory Board. “We designed the OSA trial in collaboration with a group of thought leaders in sleep apnea treatment in order to incorporate state-of-the-art technology, register sites with expertise in sleep medicine, and pinpoint the right participants to ensure high-quality data that are reflective of real-world unmet needs facing these patients. I look forward to conducting this innovative trial with Mineralys and our academic partners over the coming months.”
The planned Phase 2 clinical trial is a placebo-controlled, crossover study to evaluate the safety and efficacy of lorundrostat 50mg taken once daily in the evening in approximately 40 subjects with moderate-to-severe OSA. Subjects will be at least 18 years old, with a BMI ≥27 kg/m2, and the trial will be conducted across approximately 40 sites.
The key objective of this trial is to validate the hypothesis that lorundrostat both alleviates the severity of upper airway obstruction and reduces nocturnal hypertension. The primary outcome measure is absolute change in the frequency of apnea-hypopnea episodes. The key secondary objective is to quantify blood pressure throughout the night using continuous BP monitoring during performance of a standard sleep study without the benefit of CPAP. Standard patient reported outcomes, specific to OSA will also be assessed.
The Company believes that its current cash, cash equivalents and investments will be sufficient to fund its planned clinical trials, and support its corporate operations through the first quarter of 2026.
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 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
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
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