Satellos Bioscience, a biotech company developing new small molecule therapeutic approaches to improve the treatment of muscle diseases and disorders, today announced initial Phase 1 data in an oral presentation at the 2025 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference in Dallas, Texas.
SAT-3247 is designed to address progressive muscle loss in DMD patients by aiming to restore regeneration in response to damage. A Phase 1 trial with SAT-3247 is being conducted in healthy volunteers and adults with DMD (Phase 1a and Phase 1b, respectively).
Read More: Satellos Announces Completed Enrollment of Phase 1 Clinical Trial of SAT-3247 in Healthy Volunteers
In the Phase 1a, designed to assess the safety and tolerability of SAT-3247, 72 healthy volunteers were randomized across five single ascending dose (SAD) cohorts (including one food effect cohort) with single oral doses of up to 400 mg, and four MAD cohorts with daily oral doses up to 240 mg/day for 7 days. As of a Feb. 20, 2025, data cut-off:
- Phase 1a data showed that SAT-3247 was safe and well tolerated across all healthy volunteer cohorts. At predicted human efficacious dose levels, SAT-3247 did not display adverse clinical findings on any parameter measured, including clinical labs, vital signs, ECG, and physical exam. No moderate or greater drug-related adverse events were reported at any dose studied.
- Phase 1a PK data demonstrated consistency with results from the Company’s preclinical studies. These PK results confirm post-dose plasma concentrations of SAT-3247 are sustained at levels and time courses, which findings suggest are most likely to yield a therapeutic effect on muscle regeneration and strength.
Satellos expects to report full Phase 1a and Phase 1b data in Q2 2025.
