Satellos Bioscience has presented new data illustrating the safety, tolerability and preliminary efficacy of SAT-3247 in individuals aged 20–27 years with Duchenne muscular dystrophy (DMD).
Data from the Phase Ia/b study demonstrated that the therapy was well-tolerated and safe with a desirable pharmacokinetic profile.
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Satellos co-founder and CEO Frank Gleeson said: “Satellos’ new and updated clinical results from the 28-day clinical study in adults with Duchenne provide an important validation of SAT-3247’s potential to be a safe and clinically meaningful treatment.
“We are excited and confident in progressing into our next phase of clinical studies with the objective of demonstrating the transformative potential of SAT-3247 to the Duchenne community.”
Subjects receiving SAT-3247 over the 28-day period exhibited a notable improvement in grip strength that surpassed the natural progression typically observed in Duchenne muscular dystrophy within this age group.
A mean improvement of 118.6% in grip strength was noted in the dominant hand, alongside a 97.9% improvement in the non-dominant hand, reflecting an approximate doubling from around 2kg to 4kg.
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By GlobalDataThese enhancements were found to be inconsistent with established natural history and corresponded with elevated drug concentrations on day 15, as well as higher baseline creatinine levels, which serve as a proxy for increased muscle mass.
Five adult individuals aged between 20 and 27 years took part in the Phase Ib trial and will now enrol in an open-label follow-up trial of SAT-3247 for 11 months.
This study will also include males diagnosed with DMD aged 16–25 years.
The primary objectives are to assess the long-term tolerability and safety of SAT-3247, as well as its impact on the fat fraction in the biceps brachii muscle.
Secondary goals include the impact of SAT-3247 on muscle force and function and its effect on fat fraction.
Satellos is preparing to conduct a Phase II placebo-controlled, double-blind, randomised proof-of-concept trial of SAT-3247 in ambulatory children diagnosed with DMD.
