Satellos Bioscience, a public biotech company developing new small molecule therapeutic approaches to improve the treatment of muscle diseases and disorders, today announced it has completed enrollment of all four multiple-ascending dose (MAD) cohorts for the Phase 1 clinical trial of SAT-3247 in healthy volunteers.
“The completion of healthy volunteer enrollment in our Phase 1 trial marks a significant milestone in our mission to develop transformative therapies for patients with degenerative diseases,” said Frank Gleeson, Satellos Co-founder and CEO. “We believe SAT-3247 represents a novel, well-tolerated, and more favorable treatment option as an oral, once-daily therapy designed to restore muscle regeneration and repair in all DMD patients, whether used as a stand-alone drug or an add-on therapy. This progress sets the stage for us to present the first Phase 1 data at an upcoming major medical conference and advances our commitment to deliver meaningful solutions to the DMD community.”
SAT-3247 Announcement Summary
- Company remains on track to report Phase 1a data from both the Single- and Multiple-Ascending Dose (SAD and MAD) cohorts in the healthy volunteer portion of the study in 1Q 2025 at an upcoming major medical meeting
- The Phase 1b portion of the trial, in DMD patients, is underway with the intention of enrolling up to 10 adult volunteers with genetically confirmed DMD during 1Q 2025
- Phase 2 IND filing on track to be submitted by end of 1Q 2025
About SAT-3247 Phase 1
The Phase 1 clinical trial is comprised of two components. In the first component, 72 healthy volunteers have been enrolled in a blinded, randomized, placebo-controlled, staggered, parallel design study to assess the safety and pharmacokinetic properties of SAT-3247. Participants were randomized across five SAD cohorts, four MAD cohorts, and one food effect dose cohort. The second component, the Phase 1b portion of the trial, is currently ongoing. Up to 10 adult volunteers with genetically confirmed DMD will be enrolled in a 28-day, open-label, single dose cohort to assess safety and pharmacokinetic properties in patients and explore potential pharmacodynamic markers.
What is SAT-3247
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 (DMD or Duchenne) and other degenerative or injury conditions. Satellos is advancing SAT-3247 as a potential treatment for DMD, independent of dystrophin and regardless of exon mutation status.
