Dosing of first participant in a Phase 1 clinical trial of SAT-3247 anticipated in Q3 2024
TORONTO, Canada I August 19, 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 acceptance 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.
“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 Toronto, Ontario. For more information, visit www.satellos.com.
SOURCE: Sattelos Bioscience
Post Views: 3,453
Dosing of first participant in a Phase 1 clinical trial of SAT-3247 anticipated in Q3 2024
TORONTO, Canada I August 19, 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 acceptance 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.
“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 Toronto, Ontario. For more information, visit www.satellos.com.
SOURCE: Sattelos Bioscience
Post Views: 3,453
