Satellos Announces Acceptance of Regulatory Filing to Commence a Phase 1 Clinical Trial with SAT-3247
Satellos Bioscience Inc. (TSX: MSCL, OTCQB: MSCLF) has announced the acceptance of a regulatory filing to commence a Phase 1 clinical trial for SAT-3247, a potential oral treatment for Duchenne muscular dystrophy (DMD). The trial, expected to begin dosing in Q3 2024, will be conducted in Australia under the Therapeutic Goods Administration's Clinical Trial Notification scheme.
The study will consist of two parts: 72 healthy volunteers will participate in single-ascending dose, multiple-ascending dose, and food effect cohorts to assess safety and pharmacokinetics. Additionally, 10 adult DMD patients will be enrolled in a 28-day, open-label cohort to compare data and explore pharmacodynamic markers. This milestone marks Satellos' advancement into clinical development with a novel small molecule approach aimed at restoring muscle regeneration and repair in DMD patients.
Satellos Bioscience Inc. (TSX: MSCL, OTCQB: MSCLF) ha annunciato l'accettazione di una domanda regolatoria per avviare un trial clinico di Fase 1 per SAT-3247, un potenziale trattamento orale per la distrofia muscolare di Duchenne (DMD). Il trial, previsto per iniziare a somministrare i dosaggi nel Q3 2024, si svolgerà in Australia sotto il sistema di Notifica dei Trials Clinici dell'Amministrazione dei Prodotti Terapeutici.
Lo studio sarà composto da due parti: 72 volontari sani parteciperanno a coorti di dose singola in aumento, dose multipla in aumento e effetto del cibo per valutare la sicurezza e la farmacocinetica. Inoltre, 10 pazienti adulti con DMD saranno arruolati in una coorte a etichetta aperta di 28 giorni per confrontare i dati ed esplorare i marcatori farmacodinamici. Questo traguardo segna l'avanzamento di Satellos nello sviluppo clinico con un approccio innovativo a piccole molecole mirato a ripristinare la rigenerazione e la riparazione muscolare nei pazienti con DMD.
Satellos Bioscience Inc. (TSX: MSCL, OTCQB: MSCLF) ha anunciado la aceptación de una solicitud regulatoria para comenzar un ensayo clínico de Fase 1 para SAT-3247, un posible tratamiento oral para la distrofia muscular de Duchenne (DMD). Se espera que el ensayo comience a administrar dosis en Q3 2024 y se llevará a cabo en Australia bajo el esquema de Notificación de Ensayos Clínicos de la Administración de Bienes Terapéuticos.
El estudio constará de dos partes: 72 voluntarios sanos participarán en cohortes de dosis ascendentes únicas, dosis múltiples ascendentes y efectos de los alimentos para evaluar la seguridad y la farmacocinética. Además, 10 pacientes adultos con DMD serán incluidos en una cohorte abierta de 28 días para comparar datos y explorar marcadores farmacodinámicos. Este hito marca el avance de Satellos en el desarrollo clínico con un enfoque innovador de pequeñas moléculas destinado a restaurar la regeneración y reparación muscular en pacientes con DMD.
Satellos Bioscience Inc. (TSX: MSCL, OTCQB: MSCLF)는 뒤셴 근이영양증(DMD)을 위한 잠재적 경구 치료제 SAT-3247에 대한 1상 임상 시험을 시작하기 위한 규제 서류의 수락을 발표했습니다. 이 시험은 2024년 3분기에 투여를 시작할 예정이며, 호주에서 치료용품청의 임상 시험 통지 제도에 따라 진행됩니다.
연구는 두 부분으로 구성됩니다: 72명의 건강한 자원자가 안전성과 약물 동태를 평가하기 위해 단일 상승 용량, 다중 상승 용량 및 식이 효과 집단에 참여합니다. 추가로, 10명의 성인 DMD 환자가 데이터를 비교하고 약리역학적 표지를 탐색하기 위해 28일간의 개방형 집단에 등록될 것입니다. 이번 이정표는 근육 재생 및 수리를 복원하기 위한 혁신적인 소분자 접근법으로 Satellos의 임상 개발 진전을 나타냅니다.
Satellos Bioscience Inc. (TSX: MSCL, OTCQB: MSCLF) a annoncé l'acceptation d'un dossier réglementaire pour commencer un essai clinique de phase 1 pour SAT-3247, un traitement oral potentiel pour la dystrophie musculaire de Duchenne (DMD). L'essai, qui devrait commencer à administrer des doses au T3 2024, sera mené en Australie dans le cadre du système de notification des essais cliniques de l'Administration des produits thérapeutiques.
L'étude sera composée de deux parties : 72 volontaires en bonne santé participeront à des cohortes de dose unique ascendante, de dose multiple ascendante et d'effet alimentaire pour évaluer la sécurité et la pharmacocinétique. De plus, 10 patients adultes atteints de DMD seront recrutés dans une cohorte ouverte de 28 jours pour comparer les données et explorer les marqueurs pharmacodynamiques. Ce jalon marque les progrès de Satellos dans le développement clinique avec une approche innovante à petite molécule visant à restaurer la régénération et la réparation musculaires chez les patients atteints de DMD.
Satellos Bioscience Inc. (TSX: MSCL, OTCQB: MSCLF) hat die Annahme eines regulatorischen Antrags zur Durchführung einer Phase-1-Studie für SAT-3247 bekannt gegeben, einer möglichen oralen Behandlung für die Duchenne-Muskeldystrophie (DMD). Die Studie, die voraussichtlich im Q3 2024 mit der Dosierung beginnen wird, wird in Australien unter dem Schema zur klinischen Studienbenachrichtigung der Therapeutischen Güterverwaltung durchgeführt.
Die Studie besteht aus zwei Teilen: 72 gesunde Freiwillige werden an Gruppen teilnehmen, um die Sicherheit und Pharmakokinetik durch Einzel- und Mehrfachsteigerdosen sowie die Wirkung von Nahrungsmitteln zu bewerten. Darüber hinaus werden 10 erwachsene DMD-Patienten in eine 28-tägige offene Gruppe aufgenommen, um Daten zu vergleichen und pharmakodynamische Marker zu erkunden. Dieser Meilenstein markiert den Fortschritt von Satellos in der klinischen Entwicklung mit einem neuartigen kleinen Molekülansatz, der darauf abzielt, die Muskelregeneration und -reparatur bei DMD-Patienten wiederherzustellen.
- Acceptance of regulatory filing for Phase 1 clinical trial of SAT-3247
- Potential for SAT-3247 to be a disease-modifying oral treatment for Duchenne muscular dystrophy
- Advancement to first-in-human studies, marking a significant milestone for the company
- Dosing of first participant not expected until Q3 2024, indicating a wait before initial results
- Early-stage clinical trial with no guarantee of success or regulatory approval
Dosing of first participant in a Phase 1 clinical trial of SAT-3247 anticipated in Q3 2024
“Receiving clearance to commence clinical development of SAT-3247 represents a watershed moment for Satellos as we advance the first small molecule drug of its kind with the potential to restore the innate muscle regeneration and repair process that we discovered is dysfunctional in people living with Duchenne,” said Frank Gleeson, CEO and Co-founder of Satellos. “We are excited to be advancing SAT-3247 into first-in-human studies and begin this next important chapter for Satellos in developing an oral pill which we believe has the potential to be disease modifying.”
The Phase 1 clinical trial will comprise two components. In the first component of the study, 72 healthy volunteers will be enrolled in a blinded, randomized, placebo-controlled, staggered, parallel design to assess the safety and pharmacokinetic properties of SAT-3247. Participants will be randomized across 5 single-ascending dose (SAD) cohorts, 4 multiple-ascending dose (MAD) cohorts and one food effect (FE) dose cohort. In the second component of the study, 10 adult volunteers with genetically confirmed DMD will be enrolled in a 28-day, open-label dose cohort to compare safety and pharmacokinetic properties with the healthy volunteer data and explore pharmacodynamic markers.
About SAT-3247
SAT-3247 is a proprietary, oral small molecule drug being developed by Satellos as a novel treatment to regenerate skeletal muscle which is lost in Duchenne muscular dystrophy (DMD of Duchenne) and other degenerative or injury conditions. Satellos is advancing SAT-3247 as a potential treatment for DMD, independent of dystrophin and regardless of exon mutation status.
About Duchenne Muscular Dystrophy
Duchenne muscular dystrophy is an inherited disease caused by mutations in the dystrophin gene that no longer allow the dystrophin protein to function properly. Consequently, as discovered by Satellos, muscle repair and regeneration are impaired. Satellos designed SAT-3247 to restore the process of muscle repair and regeneration by regulating a dystrophin-independent pathway with the goal of increasing muscle function. SAT-3247 is intended to work as a standalone therapeutic without regard to a patient’s genetic mutation or ambulatory status. Our approach has the potential to complement approaches designed to restore dystrophin production.
About Satellos Bioscience Inc.
Satellos is a publicly traded biotechnology company dedicated to developing life-improving medicines to treat degenerative muscle diseases. Satellos has incorporated breakthrough research in muscle stem cell polarity into a proprietary discovery platform, called MyoReGenX™, to identify degenerative muscle diseases where deficits in this process affect muscle regeneration and are amenable to therapeutic intervention. With this platform, Satellos is building a pipeline of novel therapeutics to correct muscle stem cell polarity and promote the body’s innate muscle repair and regeneration process. The Company’s lead program is an oral, small molecule drug candidate in development as a potential disease-modifying treatment for Duchenne muscular dystrophy. Satellos is headquartered in
Notice on Forward-Looking Statements
This press release includes forward-looking information or forward-looking statements within the meaning of applicable securities laws regarding Satellos and its business, which may include, but are not limited to, statements regarding the value of our DMD program; the advancement of our lead drug candidate into clinical trials; the general benefits of modulating stem cell polarity by administering small molecule drugs; its/their prospective impact on Duchenne patients, patients with other degenerative muscle disease or muscle injury or trauma, and on muscle regeneration generally; the utility of regenerating muscle by modulating polarity; adoption of Satellos’ approach by the medical community; and Satellos’ technologies and drug development plans. All statements that are, or information which is, not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs of future performance, occurrences or developments, are “forward-looking information or statements.” Often but not always, forward-looking information or statements can be identified by the use of words such as “shall”, “intends”, “anticipate”, “believe”, “plan”, “expect”, “intend”, “estimate”, “anticipate”, “potential”, “prospective” , “assert” or any variations (including negative or plural variations) of such words and phrases, or state that certain actions, events or results “may”, “might”, “can”, “could”, “would” or “will” be taken, occur, lead to, result in, or, be achieved. Such statements are based on the current expectations and views of future events of the management of the Company. They are based on assumptions and subject to risks and uncertainties. Although management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release, may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including, without limitation, risks relating to the pharmaceutical and bioscience industry (including the risks associated with preclinical and clinical trials and regulatory approvals), and the research and development of therapeutics, the results of preclinical and clinical trials, general market conditions and equity markets, economic factors and management’s ability to manage and to operate the business of the Company generally, including inflation and the costs of operating a biopharma business, and those risks listed in the “Risk Factors” section of Satellos’ Annual Information Form dated March 26, 2024 (which is located on Satellos’ profile at www.sedarplus.ca). Although Satellos has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements or information. No forward- looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Satellos does not undertake any obligation to publicly update or revise any forward-looking statement, whether resulting from new information, future events, or otherwise.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240819805151/en/
Investors: Liz Williams, ir@satellos.com
Business Development: Ryan Mitchell, Ph.D., bd@satellos.com
Media: Jessica Yingling, Ph.D., jessica@litldog.com, +1.858.344.8091
Source: Satellos Bioscience Inc.
FAQ
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