Satellos Bioscience has dosed the first subject in a Phase I clinical trial of SAT-3247, a potential treatment for Duchenne muscular dystrophy (DMD) and other muscle degeneration or injury-related conditions.
An oral small molecule drug, SAT-3247 targets AAK1. It is created to promote skeletal muscle regeneration in DMD and similar disorders.
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The Phase I trial consists of two parts.
The double-blind, randomised, placebo-controlled initial portion will enrol 72 healthy participants to evaluate the safety and pharmacokinetics of SAT-3247.
This phase will include five single-ascending dose (SAD) cohorts, four multiple-ascending dose (MAD) cohorts, and one cohort to assess the food effect on the drug.
The second phase, anticipated to start late in the fourth quarter (Q4) of 2024, will enrol ten adult volunteers with confirmed DMD for a 28-day, open-label, single-dose study.
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By GlobalDataIt will further assess the safety, pharmacokinetics, and potential pharmacodynamic markers. Initial safety and pharmacokinetic data from the trial are expected in Q4 2024.
Satellos CEO and co-founder Frank Gleeson said: “We are excited to announce the dosing of the first participants in our Phase I 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.
“We look forward to advancing this trial and gaining valuable insights into the safety and pharmacological profile of SAT-3247.”
Last month, the Human Research Ethics Committee (HREC) in Australia accepted the clinical research proposal to execute the first-in-human Phase trial of SAT-3247.
The company had sought regulatory authorisation to commence the trial under the Therapeutic Goods Administration’s (TGA’s) Clinical Trial Notification (CTN) scheme.
During the same time, the US Food and Drug Administration (FDA) granted rare pediatric disease designation to SAT-3247 to treat DMD.
