Satellos Bioscience, today announced its financial results and corporate highlights for the first quarter ended March 31, 2025.
“We are very pleased with our continued progress in the advancement of SAT-3247,” said Frank Gleeson, Co-founder and Chief Executive Officer. “We plan to share data from our Phase 1b study in adult DMD patients in Q2 2025, marking another key development milestone. As a Company, we believe we are well positioned to advance our novel drug into a randomized, placebo-controlled Phase 2 POC trial in pediatric DMD patients as our next major development step. This study will be designed to further assess the safety of SAT-3247 in a key pediatric population, while exploring its possible utility in restoring the body’s ability to repair and regenerate damaged or lost muscle.”
Satellos SAT-3247 Q1 2025 Results
- Completed enrollment in the Phase 1b trial in adult patients with Duchenne muscular dystrophy (DMD); data analysis and reporting expected in Q2 2025
- Received regulatory approval, allowing initiation of a long-term follow-up study to treat DMD patients from the Phase 1b for 11 additional months
- Profile of SAT-3247, presented at the Muscular Dystrophy Association (MDA) Conference, demonstrated the drug to be safe and well tolerated with a predictable pharmacokinetic (PK) profile in healthy volunteers
- Global regulatory filings to obtain approvals to initiate a Phase 2 randomized, placebo-controlled proof-of-concept clinical (POC) trial in pediatric DMD patients expected to be submitted in Q3 2025
Satellos SAT-3247 Clinical Progress
- On March 19, 2025, Satellos presented initial Phase 1a data at the MDA Clinical & Scientific Conference in Dallas, TX. The data showed SAT-3247 was safe, well tolerated, and consistent with the Company’s preclinical PK predictions, following both single and repeat dose administration. – Data from the Phase 1 Trial of SAT-3247 –
- Phase 1b trial in up to 10 adult DMD patients has completed enrollment. The study is a 28-day, open-label design to assess safety, PK, and exploratory pharmacodynamic markers.
- Satellos expects to complete analysis and report full Phase 1 data in Q2 2025.
- Long-term follow-up clinical study, enabling treatment of Phase 1b patients for up to an additional 11 months, received regulatory approved in Australia. – Satellos Prepares to Launch Phase 2 Clinical Study of SAT-3247 –
- Regulatory filings seeking approval for a global Phase 2 randomized, placebo-controlled POC trial in pediatric DMD patients planned for Q3 2025.
