09:19 AM EDT, 08/19/2024 (MT Newswires) -- Satellos Bioscience ( MSCLF ) on Monday said Australia's Human Research Ethics Committee (HREC) has approved the company's Phase 1 clinical trial of SAT-3247, its lead candidate which is being advanced as a potential treatment for Duchenne muscular dystrophy (DMD).

The Phase 1 trial will have two components. In the first, 72 healthy volunteers will be enrolled in a blinded, placebo-controlled study to assess the safety and pharmacokinetic properties of SAT-3247. In the second component, 10 adult volunteers with genetically confirmed Duchenne muscular dystrophy (DMD) will be enrolled in a 28-day, open-label dose cohort to compare safety and pharmacokinetic properties with the healthy volunteer data and explore pharmacodynamic markers.

"Receiving clearance to commence clinical development of SAT-3247 represents a watershed moment for Satellos as we advance the first small molecule drug of its kind with the potential to restore the innate muscle regeneration and repair process that we discovered is dysfunctional in people living with Duchenne," said Satellos CEO Frank Gleeson. "We are excited to be advancing SAT-3247 into first-in-human studies and begin this next important chapter for Satellos in developing an oral pill which we believe has the potential to be disease modifying."