– Investigational New Drug (IND) enabling preclinical and toxicology studies successfully completed
– Initiation of a Phase 1 clinical trial of SAT-3247 anticipated in Q3 2024
TORONTO, Canada I July 11, 2024 I Satellos Bioscience Inc. (“Satellos” or the “Company”) (TSX: MSCL, OTCQB: MSCLF), a public biotech company developing new small molecule therapeutic approaches to improve the treatment of muscle diseases and disorders, today announced submission on July 10, 2024, of a clinical research proposal to a Human Research Ethics Committee (HREC) in Australia seeking regulatory authorization under their Therapeutic Goods Administration’s (TGA’s) Clinical Trial Notification (CTN) scheme to conduct a first-in-human Phase 1 clinical trial of SAT-3247.
“We view this as a transformative development for Satellos as we become a clinical-stage company,” said Frank Gleeson, CEO and Co-founder of Satellos. “Our team is proud to have reached this important milestone on the timeline we have been working towards for the past year and see this achievement as a catalyst towards a steady cadence of milestones to come.”
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) and other degenerative or injury conditions. Subject to approval by the HREC and acceptance of the CTN by Australia’s TGA, the Phase 1 clinical trial is intended to enroll healthy volunteers to assess the safety and pharmacokinetic properties of SAT-3247. Following completion of this portion of its program, if successful, Satellos plans to advance SAT-3247 into clinical trials with DMD patients commencing in early 2025.
“We are pleased with the results from our preclinical studies and look forward to initiating clinical development of SAT-3247,” said Phil Lambert, Ph.D., Chief Scientific Officer of Satellos. “Prior to submitting our regulatory documentation, we conducted our preclinical and toxicology studies to the standards of relevant global regulatory bodies. Thus, we expect to be able to leverage these results for additional Phase 1 and subsequent clinical trials in Australia and further jurisdictions including the United States and Canada, where we plan to advance into trials with DMD patients.”
About SAT-3247
SAT-3247 is an oral, small molecule drug candidate designed to target the root cause of muscle loss in degenerative diseases, initially in Duchenne. SAT-3247 presents a novel mechanism of action to restore impaired muscle regeneration caused by the absence of functional dystrophin.
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 Toronto, Ontario. For more information, visit www.satellos.com.
SOURCE: Satellos Bioscience
Post Views: 4,536
– Investigational New Drug (IND) enabling preclinical and toxicology studies successfully completed
– Initiation of a Phase 1 clinical trial of SAT-3247 anticipated in Q3 2024
TORONTO, Canada I July 11, 2024 I Satellos Bioscience Inc. (“Satellos” or the “Company”) (TSX: MSCL, OTCQB: MSCLF), a public biotech company developing new small molecule therapeutic approaches to improve the treatment of muscle diseases and disorders, today announced submission on July 10, 2024, of a clinical research proposal to a Human Research Ethics Committee (HREC) in Australia seeking regulatory authorization under their Therapeutic Goods Administration’s (TGA’s) Clinical Trial Notification (CTN) scheme to conduct a first-in-human Phase 1 clinical trial of SAT-3247.
“We view this as a transformative development for Satellos as we become a clinical-stage company,” said Frank Gleeson, CEO and Co-founder of Satellos. “Our team is proud to have reached this important milestone on the timeline we have been working towards for the past year and see this achievement as a catalyst towards a steady cadence of milestones to come.”
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) and other degenerative or injury conditions. Subject to approval by the HREC and acceptance of the CTN by Australia’s TGA, the Phase 1 clinical trial is intended to enroll healthy volunteers to assess the safety and pharmacokinetic properties of SAT-3247. Following completion of this portion of its program, if successful, Satellos plans to advance SAT-3247 into clinical trials with DMD patients commencing in early 2025.
“We are pleased with the results from our preclinical studies and look forward to initiating clinical development of SAT-3247,” said Phil Lambert, Ph.D., Chief Scientific Officer of Satellos. “Prior to submitting our regulatory documentation, we conducted our preclinical and toxicology studies to the standards of relevant global regulatory bodies. Thus, we expect to be able to leverage these results for additional Phase 1 and subsequent clinical trials in Australia and further jurisdictions including the United States and Canada, where we plan to advance into trials with DMD patients.”
About SAT-3247
SAT-3247 is an oral, small molecule drug candidate designed to target the root cause of muscle loss in degenerative diseases, initially in Duchenne. SAT-3247 presents a novel mechanism of action to restore impaired muscle regeneration caused by the absence of functional dystrophin.
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 Toronto, Ontario. For more information, visit www.satellos.com.
SOURCE: Satellos Bioscience
Post Views: 4,536
