– 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
TORONTO, Canada I September 18, 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, announced today that the first participant has been dosed in a Phase 1 clinical study of SAT-3247. SAT-3247 is a novel, oral small molecule drug targeting AAK1 that is designed to regenerate skeletal muscle in Duchenne muscular dystrophy (DMD or Duchenne) and other degenerative or injury conditions involving muscle tissue.
“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 Toronto, Ontario. For more information, visit www.satellos.com.
SOURCE: Satellos Bioscience
Post Views: 3,578
– 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
TORONTO, Canada I September 18, 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, announced today that the first participant has been dosed in a Phase 1 clinical study of SAT-3247. SAT-3247 is a novel, oral small molecule drug targeting AAK1 that is designed to regenerate skeletal muscle in Duchenne muscular dystrophy (DMD or Duchenne) and other degenerative or injury conditions involving muscle tissue.
“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 Toronto, Ontario. For more information, visit www.satellos.com.
SOURCE: Satellos Bioscience
Post Views: 3,578
