Satellos Submits Regulatory Filing for Phase 1 Trial of SAT-3247

Satellos Bioscience Inc., a publicly traded biotechnology company, has made significant strides in the treatment of muscle diseases and disorders with their innovative small molecule therapeutic approaches. On July 10, 2024, the company announced that it has submitted a clinical research proposal to the Human Research Ethics Committee (HREC) in Australia. This submission seeks regulatory authorization under the Therapeutic Goods Administration’s (TGA) Clinical Trial Notification (CTN) scheme to initiate a first-in-human Phase 1 clinical trial for their novel drug candidate, SAT-3247.

Frank Gleeson, the CEO and Co-founder of Satellos, emphasized the importance of this development, stating that it transitions Satellos from a preparatory stage to a clinical-stage company. He highlighted the dedication and hard work of the team over the past year, viewing this milestone as a catalyst for future progress.

SAT-3247, an oral small molecule drug, is being developed as a potential treatment to regenerate skeletal muscle in patients with Duchenne muscular dystrophy (DMD) and other degenerative or injury-related muscle conditions. The planned Phase 1 clinical trial will enroll healthy volunteers to evaluate the safety and pharmacokinetic properties of SAT-3247. Following the successful completion of this trial phase, Satellos intends to advance SAT-3247 into clinical trials with DMD patients, targeting early 2025 for this next step.

Phil Lambert, Ph.D., Chief Scientific Officer of Satellos, expressed satisfaction with the preclinical studies' results and the anticipation of moving into clinical development. The preclinical and toxicology studies were conducted to the standards required by relevant global regulatory bodies, which Satellos expects will facilitate subsequent clinical trials not only in Australia but also in other jurisdictions such as the United States and Canada.

SAT-3247 is particularly noteworthy for its unique mechanism of action aimed at addressing the root cause of muscle loss in degenerative diseases, with an initial focus on Duchenne muscular dystrophy. The drug is designed to restore impaired muscle regeneration, which is a consequence of the absence of functional dystrophin. Satellos aims for SAT-3247 to function as a standalone therapeutic, independent of a patient's specific genetic mutation or ambulatory status, potentially complementing therapies aimed at restoring dystrophin production.

Duchenne muscular dystrophy is caused by mutations in the dystrophin gene, leading to improper functioning of the dystrophin protein and subsequent impairment in muscle repair and regeneration. Satellos has tailored SAT-3247 to restore the muscle repair process by regulating a dystrophin-independent pathway, thereby enhancing muscle function.

Satellos Bioscience Inc. is headquartered in Toronto, Ontario, and is focused on developing life-improving medicines for degenerative muscle diseases. The company's innovative discovery platform, MyoReGenX™, leverages breakthrough research in muscle stem cell polarity to identify and target degenerative muscle diseases where muscle regeneration is compromised. This platform supports the development of a pipeline of novel therapeutics designed to correct muscle stem cell polarity and promote the body's natural muscle repair and regeneration processes. The lead program in this initiative is SAT-3247, an oral small molecule drug candidate under development for Duchenne muscular dystrophy, which represents a potential disease-modifying treatment.