07:40 AM EDT, 09/22/2025 (MT Newswires) -- Satellos Bioscience ( MSCLF ) Monday said it has submitted an Investigational New Drug (IND) application to the U.S. FDA to initiate a Phase 2 clinical trial of its lead compound SAT-3247 in children with Duchenne muscular dystrophy (DMD). The company is also filing applications to the U.K., Europe, Serbia and Australia.

The three-month Phase 2 trial will enroll children in the U.S., and will assess safety and tolerability and key measures of strength, function, biomarkers, and muscle health, with the first patient expected to be enrolled by the end of this year. A nine-month extension for this study is also being planned.

Satellos has also initiated an 11-month extension study in Australia to evaluate long-term safety and efficacy among individuals who participated in the recently-completed Phase 1b trial.

"Filing our Phase 2 clinical trial submissions in the U.S. and globally marks a major milestone for Satellos in advancing SAT-3247's potential to treat Duchenne in a novel way," said chief executive Frank Gleeson.

"Current therapies do not address the fundamental challenge in Duchenne, which we have identified - the body's impaired muscle-repair process. With SAT-3247, our goal is to re-boot that regenerative cycle with the potential to restore muscle, improve functional outcomes and truly change lives."

SAT-3247 is an oral small-molecule therapy designed to restore the body's ability to regenerate muscle, a process that is impaired in Duchenne.

Satellos has also exercised 1.74 million warrants, raising $1.04 million. The warrants were issued three years ago.