Satellos Announces Dosing of First Participant in Phase 1 Clinical Study of SAT-3247
Satellos Bioscience Inc. (TSX: MSCL) (OTCQB: MSCLF) has initiated a Phase 1 clinical study for SAT-3247, a novel oral small molecule drug targeting AAK1. The drug is designed to regenerate skeletal muscle in Duchenne muscular dystrophy (DMD) and other muscle degenerative conditions. The study comprises two components:
1. A trial with 72 healthy volunteers to assess safety and pharmacokinetics, including single-ascending dose (SAD), multiple-ascending dose (MAD), and food effect cohorts.
2. A 28-day, open-label, single dose cohort with 10 adult DMD patients, expected to begin in late Q4 2024.
Initial safety and pharmacokinetic data are anticipated in Q4 2024, with the DMD patient component starting in Q1 2025.
Satellos Bioscience Inc. (TSX: MSCL) (OTCQB: MSCLF) ha avviato uno studio clinico di Fase 1 per SAT-3247, un nuovo farmaco orale in piccole molecole mirato all'AAK1. Il farmaco è progettato per rigenerare il tessuto muscolare scheletrico nella distrofia muscolare di Duchenne (DMD) e in altre condizioni degenerative muscolari. Lo studio comprende due componenti:
1. Un trial con 72 volontari sani per valutare la sicurezza e la farmacocinetica, inclusi gruppi per dose singola in aumento (SAD), dose multipla in aumento (MAD) e effetto del cibo.
2. Un gruppo di coorte a dose singola in aperto di 28 giorni con 10 pazienti adulti affetti da DMD, previsto per iniziare alla fine del Q4 2024.
I dati iniziali sulla sicurezza e la farmacocinetica sono attesi nel Q4 2024, con la componente per i pazienti DMD che inizierà nel Q1 2025.
Satellos Bioscience Inc. (TSX: MSCL) (OTCQB: MSCLF) ha iniciado un estudio clínico de Fase 1 para SAT-3247, un nuevo fármaco oral de pequeñas moléculas dirigido a AAK1. El fármaco está diseñado para regenerar el músculo esquelético en la distrofia muscular de Duchenne (DMD) y otras condiciones degenerativas musculares. El estudio consta de dos componentes:
1. Un ensayo con 72 voluntarios sanos para evaluar la seguridad y la farmacocinética, incluidos grupos de dosis única ascendente (SAD), dosis múltiple ascendente (MAD) y efecto de los alimentos.
2. Un grupo de cohorte de dosis única a etiqueta abierta de 28 días con 10 pacientes adultos con DMD, que se espera comience a finales del Q4 de 2024.
Se anticipan datos iniciales de seguridad y farmacocinética en el Q4 de 2024, comenzando la componente para pacientes DMD en el Q1 de 2025.
Satellos Bioscience Inc. (TSX: MSCL) (OTCQB: MSCLF)는 1상 임상 시험을 시작했습니다 SAT-3247에 대한 것으로, AAK1을 타겟으로 하는 새로운 경구용 소분자 약물입니다. 이 약물은 뒤셴 근육디스트로피(DMD) 및 기타 근육퇴행성 질환에서 골격근을 재생하기 위해 설계되었습니다. 이 연구는 두 가지 구성 요소로 나뉩니다:
1. 안전성과 약물 동태를 평가하기 위해 72명의 건강한 자원자를 대상으로 하는 시험으로, 단회 용량 상승(SAD), 반복 용량 상승(MAD), 음식 효과 코호트가 포함됩니다.
2. 10명의 성인 DMD 환자와 함께하는 28일간의 공개 라벨 단회 투여 코호트가 2024년 4분기 말에 시작될 것으로 예상됩니다.
초기 안전성 및 약물 동태 데이터는 2024년 4분기에 예상되며, DMD 환자 구성 요소는 2025년 1분기에 시작될 것입니다.
Satellos Bioscience Inc. (TSX: MSCL) (OTCQB: MSCLF) a initié une étude clinique de Phase 1 pour SAT-3247, un nouvel médicament oral à petites molécules ciblant l'AAK1. Ce médicament est conçu pour régénérer le muscle squelettique dans la dystrophie musculaire de Duchenne (DMD) et d'autres conditions dégénératives musculaires. L'étude comprend deux composants :
1. Un essai avec 72 volontaires en bonne santé pour évaluer la sécurité et la pharmacocinétique, y compris des cohortes à dose unique ascendante (SAD), à dose multiple ascendante (MAD) et l'effet des aliments.
2. Une cohorte à dose unique à étiquette ouverte de 28 jours avec 10 patients adultes atteints de DMD, prévue pour débuter fin T4 2024.
Les premières données de sécurité et de pharmacocinétique sont attendues pour le T4 2024, avec la composante pour patients DMD débutant au T1 2025.
Satellos Bioscience Inc. (TSX: MSCL) (OTCQB: MSCLF) hat eine Phase-1-Studie initiiert für SAT-3247, ein neuartiges orales kleines Molekülmedikament, das auf AAK1 abzielt. Das Medikament soll die Skelettmuskulatur bei der Duchenne-Muskeldystrophie (DMD) und anderen muskeldystrophischen Erkrankungen regenerieren. Die Studie besteht aus zwei Komponenten:
1. Eine Studie mit 72 gesunden Freiwilligen zur Bewertung von Sicherheit und Pharmakokinetik, einschließlich Gruppen für einmalige Dosissteigerung (SAD), mehrfache Dosissteigerung (MAD) und den Nahrungsaufnahme-Effekt.
2. Eine 28-tägige, offene Einzel-Dosis-Kohorte mit 10 erwachsenen DMD-Patienten, deren Beginn für Ende Q4 2024 erwartet wird.
Die ersten Sicherheits- und Pharmakokinetikdaten werden im Q4 2024 erwartet, mit der Patientenkomponente für DMD, die im Q1 2025 beginnt.
- Initiation of Phase 1 clinical trial for SAT-3247, advancing Satellos to a clinical-stage company
- Potential for SAT-3247 to regenerate skeletal muscle in DMD and other muscle conditions
- Comprehensive study design including both healthy volunteers and DMD patients
- Initial safety and pharmacokinetic data not expected until Q4 2024
- DMD patient component of the study delayed until Q1 2025
- The first healthy volunteer has been dosed in the first component of the Phase 1 study
- Initial safety and pharmacokinetic data expected in Q4 2024
- Initiation of the second component of the Phase 1 study, in adult DMD patients, expected in Q1 2025
"We are excited to announce the dosing of the first participants in our Phase 1 clinical trial of SAT-3247, transforming Satellos into a clinical stage company. This milestone marks a significant step in our commitment to developing innovative therapies to regenerate muscle for those living with Duchenne and other muscle degenerative or injury conditions," said Frank Gleeson, Co-founder and CEO, Satellos. "We look forward to advancing this trial and gaining valuable insights into the safety and pharmacological profile of SAT-3247."
The Phase 1 clinical trial will comprise two components. In the first component, 72 healthy volunteers will be enrolled in a blinded, randomized, placebo-controlled, staggered, parallel design study to assess the safety and pharmacokinetic properties of SAT-3247. Participants will be randomized across five single-ascending dose (SAD) cohorts, four multiple-ascending dose (MAD) cohorts, and one food effect dose cohort. In the second component, expected to begin in late Q4 2024, 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 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 MyoReGenXTM, 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 clinical 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 expected structure and progress of our clinical trials and any potential insights or results that may be obtained from them; the general benefits of modulating stem cell polarity by administering small molecule drugs, including our lead drug candidate; 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 our lead drug candidate and of regenerating muscle by modulating polarity generally; 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/20240918008946/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.
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