Satellos Announces Completed Enrollment of all Four Multiple-Ascending Dose Cohorts for the Phase 1 Clinical Trial of SAT-3247 in Healthy Volunteers
Satellos Bioscience (TSX: MSCL, OTCQB: MSCLF) has completed enrollment of all four multiple-ascending dose (MAD) cohorts in its Phase 1 clinical trial of SAT-3247 in healthy volunteers. The company remains on track to report Phase 1a data from both Single-Ascending Dose (SAD) and MAD cohorts in Q1 2025.
The Phase 1b portion of the trial, targeting Duchenne Muscular Dystrophy (DMD) patients, is currently underway with plans to enroll up to 10 adult volunteers with genetically confirmed DMD during Q1 2025. The company also expects to submit its Phase 2 IND filing by the end of Q1 2025.
SAT-3247 is being developed as an oral, once-daily therapy aimed at restoring muscle regeneration and repair in all DMD patients, with potential use as either a standalone or add-on treatment.
Satellos Bioscience (TSX: MSCL, OTCQB: MSCLF) ha completato l'arruolamento di tutti e quattro i gruppi di dosaggio ascendente multiplo (MAD) nel suo studio clinico di Fase 1 su SAT-3247 in volontari sani. L'azienda è in linea per riportare i dati della Fase 1a sia dai gruppi di Dosaggio Ascendente Singolo (SAD) che da quelli MAD nel Q1 2025.
La parte Fase 1b dello studio, focalizzata sui pazienti con Distrofia Muscolare di Duchenne (DMD), è attualmente in corso con piani per arruolare fino a 10 volontari adulti con DMD confermata geneticamente durante il Q1 2025. L'azienda si aspetta anche di presentare la domanda IND per la Fase 2 entro la fine del Q1 2025.
SAT-3247 è in fase di sviluppo come terapia orale da assumere una volta al giorno, mirata a ripristinare la rigenerazione e la riparazione muscolare in tutti i pazienti con DMD, con un potenziale utilizzo sia come trattamento autonomo che come trattamento aggiuntivo.
Satellos Bioscience (TSX: MSCL, OTCQB: MSCLF) ha completado el reclutamiento de todos los cuatro cohortes de dosis múltiples ascendentes (MAD) en su ensayo clínico de Fase 1 de SAT-3247 en voluntarios sanos. La compañía sigue en camino de informar los datos de la Fase 1a tanto de los cohortes de Dosis Ascendente Única (SAD) como de los MAD en Q1 2025.
La parte de Fase 1b del ensayo, que se centra en pacientes con Distrofia Muscular de Duchenne (DMD), está actualmente en marcha con planes de reclutar hasta 10 voluntarios adultos con DMD confirmada genéticamente durante el Q1 2025. La compañía también espera presentar su solicitud IND de Fase 2 antes del final del Q1 2025.
SAT-3247 se está desarrollando como una terapia oral de una vez al día, destinada a restaurar la regeneración y reparación muscular en todos los pacientes con DMD, con un uso potencial tanto como tratamiento independiente como complemento.
Satellos Bioscience (TSX: MSCL, OTCQB: MSCLF)는 건강한 자원봉사자를 대상으로 한 SAT-3247의 1상 임상 시험에서 네 개의 다중 상승 용량(MAD) 코호트를 모두 등록 완료했습니다. 회사는 2025년 1분기에 단일 상승 용량(SAD) 및 MAD 코호트 모두의 1상 a 데이터 보고를 예정하고 있습니다.
임상의 1b 단계는 뒤셴형 근이영양증(DMD) 환자를 대상으로 현재 진행 중이며, 2025년 1분기에 유전적으로 확인된 DMD 환자 성인 자원봉사자를 최대 10명 모집할 계획입니다. 회사는 또한 2025년 1분기 말까지 2상 IND 제출을 예상하고 있습니다.
SAT-3247는 모든 DMD 환자에서 근육 재생 및 수리를 복원하기 위해 하루에 한 번 복용하는 경구 치료제로 개발되고 있으며, 독립적으로 또는 보조 치료제로 사용될 가능성이 있습니다.
Satellos Bioscience (TSX: MSCL, OTCQB: MSCLF) a terminé le recrutement de tous les quatre cohortes de dose multiple ascendante (MAD) dans son essai clinique de Phase 1 sur le SAT-3247 chez des volontaires sains. La société est sur la bonne voie pour rapporter les données de la Phase 1a des cohortes à dose unique ascendante (SAD) et MAD au Q1 2025.
La partie Phase 1b de l'essai, destinée aux patients atteints de dystrophie musculaire de Duchenne (DMD), est actuellement en cours avec des plans pour recruter jusqu'à 10 volontaires adultes porteurs d'une DMD confirmée génétiquement au cours du Q1 2025. La société s'attend également à soumettre son dossier IND pour la Phase 2 d'ici la fin du Q1 2025.
Le SAT-3247 est en cours de développement en tant que thérapie orale à prendre une fois par jour, visant à restaurer la régénération et la réparation musculaires chez tous les patients atteints de DMD, avec un usage potentiel en tant que traitement autonome ou en complément.
Satellos Bioscience (TSX: MSCL, OTCQB: MSCLF) hat die Rekrutierung aller vier Kohorten für die mehrfach steigende Dosis (MAD) in seiner Phase-1-Studie zu SAT-3247 bei gesunden Freiwilligen abgeschlossen. Das Unternehmen ist auf dem richtigen Weg, die Daten der Phase 1a sowohl aus den Einzeldosis (SAD) als auch aus den MAD-Kohorten im Q1 2025 zu berichten.
Der Teil Phase 1b der Studie, der sich auf Patienten mit Duchenne-Muskeldystrophie (DMD) konzentriert, läuft derzeit mit dem Ziel, bis zu 10 erwachsene Freiwillige mit genetisch bestätigter DMD im Q1 2025 zu rekrutieren. Das Unternehmen plant außerdem, seinen IND-Antrag für Phase 2 bis Ende Q1 2025 einzureichen.
SAT-3247 wird als orale Therapie entwickelt, die einmal täglich eingenommen wird und darauf abzielt, die Muskelregeneration und -reparatur bei allen DMD-Patienten wiederherzustellen, mit dem Potenzial, entweder als eigenständige oder als Zusatztherapie eingesetzt zu werden.
- Completed enrollment of all four MAD cohorts in Phase 1 trial
- Phase 1b trial in DMD patients already underway
- On track for Phase 2 IND filing by Q1 2025
- Development of oral, once-daily therapy offering potential treatment flexibility
- Phase 1 data results not yet available
- Phase 1b patient enrollment still pending
- Company remains on track to report Phase 1a data from both the Single- and Multiple-Ascending Dose (SAD and MAD) cohorts in the healthy volunteer portion of the study in 1Q 2025 at an upcoming major medical meeting
- The Phase 1b portion of the trial, in DMD patients, is underway with the intention of enrolling up to 10 adult volunteers with genetically confirmed DMD during 1Q 2025
- Phase 2 IND filing on track to be submitted by end of 1Q 2025
“The completion of healthy volunteer enrollment in our Phase 1 trial marks a significant milestone in our mission to develop transformative therapies for patients with degenerative diseases,” said Frank Gleeson, Satellos Co-founder and CEO. “We believe SAT-3247 represents a novel, well-tolerated, and more favorable treatment option as an oral, once-daily therapy designed to restore muscle regeneration and repair in all DMD patients, whether used as a stand-alone drug or an add-on therapy. This progress sets the stage for us to present the first Phase 1 data at an upcoming major medical conference and advances our commitment to deliver meaningful solutions to the DMD community.”
About Phase 1 DMD Trial
The Phase 1 clinical trial is comprised of two components. In the first component, 72 healthy volunteers have been enrolled in a blinded, randomized, placebo-controlled, staggered, parallel design study to assess the safety and pharmacokinetic properties of SAT-3247. Participants were randomized across five SAD cohorts, four MAD cohorts, and one food effect dose cohort. The second component, the Phase 1b portion of the trial, is currently ongoing. Up to 10 adult volunteers with genetically confirmed DMD will be enrolled in a 28-day, open-label, single dose cohort to assess safety and pharmacokinetic properties in patients and explore potential 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 or 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 Satellos Bioscience Inc.
Satellos is a clinical-stage drug development company dedicated to developing life-improving medicines to treat degenerative muscle diseases. Satellos has invented SAT-3247 as a first-of-its-kind, orally administered small molecule drug designed to restore skeletal muscle regeneration in degenerative or injury conditions by correcting muscle stem cell polarity. Satellos has generated a body of preclinical evidence with SAT-3247 to support its discovery that correcting muscle stem cell polarity has the potential to restore skeletal muscle regeneration to repair and strengthen muscle that has degenerated or been damaged. SAT-3247 is currently in clinical development as a potential disease-modifying treatment initially for DMD. Additionally, Satellos is leveraging its breakthrough research and proprietary discovery platform MyoReGenX™, to identify additional degenerative muscle diseases or injury conditions where deficits in muscle regeneration occur that are amenable to therapeutic intervention for future clinical development. For more information, visit www.satellos.com.
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 expected timing for the presentation of Phase 1 data and the filing of the Phase 2 IND; the expectations regarding enrollment in the Company's Phase 1b trial; the potential for SAT-3247 to represent a disease modifying approach to the therapeutic treatment of people living with Duchenne; anticipated benefits to patients from a small molecule treatment for Duchenne; the advancement SAT-3247 through clinical trials; the pharmacodynamic properties and mechanism-of-action of SAT-3247; the potential of our approach in other degenerative muscle diseases or in muscle injury or trauma; 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; 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/20250210946404/en/
Investors: Liz Williams, CFO, ir@satellos.com
Media: Jessica Yingling, Ph.D., jessica@litldog.com
Clinical Trial Info: medicalinfo@satellos.com
Source: Satellos Bioscience Inc.
FAQ
When will Satellos (MSCLF) report Phase 1a results for SAT-3247?
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Can SAT-3247 be used with other DMD treatments?
