Satellos Bioscience has concluded the enrolment of subjects for all four multiple-ascending dose (MAD) cohorts for the Phase I trial of the oral small-molecule drug SAT-3247.
The drug is being developed as a new treatment for regenerating skeletal muscle, which is lost in Duchenne muscular dystrophy (DMD).
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The Phase I trial involves two parts, with the first involving 72 healthy volunteers in a study designed to evaluate the pharmacokinetic and safety properties of the drug.
Subjects were randomised across various cohorts, including four MAD, five single-ascending doses (SAD), as well as one food effect dose cohort.
The other part, Phase Ib, is currently in progress, aiming to enrol up to ten adult volunteers having genetically confirmed DMD to evaluate the drug’s pharmacokinetic, safety properties, and potential pharmacodynamic markers in a 28-day, single-dose cohort.
Enrolment in this trial is expected to continue through the first quarter of 2025.
Satellos is on track to submit a Phase II investigational new drug (IND) filing by the end of the first quarter.
Satellos Bioscience co-founder and CEO Frank Gleeson said: “The completion of healthy volunteer enrollment in our Phase I trial marks a significant milestone in our mission to develop transformative therapies for patients with degenerative diseases.
“We believe SAT-3247 represents a novel, well-tolerated, and more favourable treatment option as an oral, once-daily therapy designed to restore muscle regeneration and repair in all DMD patients, whether used as a standalone drug or an add-on therapy.”
The company develops treatments for degenerative muscle diseases and has designed the drug to correct muscle stem cell polarity, thereby restoring skeletal muscle regeneration.
Preclinical evidence supports this approach, suggesting that SAT-3247 could repair and strengthen degenerated or damaged muscles.
In addition to SAT-3247’s current clinical development for DMD, the company is exploring other degenerative muscle diseases or injury conditions that may benefit from therapeutic intervention using its discovery platform, MyoReGenX.
