Satellos Bioscience Inc. announced submission on July 10, 2024, of a clinical research proposal to a Human Research Ethics Committee (HREC) in Australia seeking regulatory authorization under their Therapeutic Goods Administration’s (TGA’s) Clinical Trial Notification (CTN) scheme to conduct a first-in-human Phase 1 clinical trial of SAT-3247. Read the full Press Release below.

Press release highlights:

• Investigational New Drug (IND) enabling preclinical and toxicology studies successfully completed
• Initiation of a Phase 1 clinical trial of SAT-3247 anticipated in Q3 2024
• Intention to leverage results for additional Phase 1 and subsequent clinical trials in Australia and further jurisdictions including the United States and Canada.

SAT-3247 is a proprietary, oral small molecule drug being developed by Satellos as a novel treatment to regenerate skeletal muscle which is lost in Duchenne muscular dystrophy and other degenerative or injury conditions. Subject to approval by the HREC and acceptance of the CTN by Australia’s TGA, the Phase 1 clinical trial is intended to enroll healthy volunteers to assess the safety and pharmacokinetic properties of SAT-3247. Following completion of this portion of its program, if successful, Satellos plans to advance SAT-3247 into clinical trials with DMD patients commencing in early 2025.

“We are pleased with the results from our preclinical studies and look forward to initiating clinical development of SAT-3247. Prior to submitting our regulatory documentation, we conducted our preclinical and toxicology studies to the standards of relevant global regulatory bodies. Thus, we expect to be able to leverage these results for additional Phase 1 and subsequent clinical trials in Australia and further jurisdictions including the United States and Canada, where we plan to advance into trials with DMD patients.”

Phil Lambert, Ph.D., Chief Scientific Officer of Satellos

What is SAT-3247?

SAT-3247 is an oral, small molecule drug candidate designed to target the root cause of muscle loss in degenerative diseases, initially in Duchenne. SAT-3247 presents a novel mechanism of action to restore impaired muscle regeneration caused by the absence of functional dystrophin.

Defeat Duchenne Canada is pleased to be currently funding the work of Dr. Mike Rudnicki, who is the Director of the Regenerative Medicine Program at the Ottawa Research Institute and is also the Chief Scientific Officer of Satellos Bioscience Inc.