Satellos Bioscience Begins Phase 1B Trial for Duchenne Muscular Dystrophy
Toronto, Wednesday, 11 December 2024.
Satellos Bioscience has dosed the first participant in their Phase 1B trial of SAT-3247, marking a key step in developing treatments for Duchenne Muscular Dystrophy.
Trial Details and Company Overview
Satellos Bioscience Inc. (TSE:MSCL) [3] initiated this significant phase in their clinical development process on December 5, 2024 [4]. The Phase 1B trial will focus on safety and pharmacokinetics assessment in patients with Duchenne muscular dystrophy (DMD) [1]. The company plans to enroll up to 10 adult participants with genetically confirmed DMD in a 28-day, open-label, single dose cohort study [1].
Promising Early Results
Prior to this Phase 1B trial, SAT-3247 has shown encouraging results in earlier testing phases. The drug demonstrated positive safety outcomes in healthy volunteers during the Single Ascending Dose (SAD) cohorts and the first cohort of Multiple Ascending Dose (MAD) studies [1]. Notably, these earlier trials reported no drug-related adverse events, with normal findings across clinical labs, vitals, ECG, and physical examinations [1].
Broader Clinical Development Program
The current trial is part of a comprehensive Phase 1 clinical program that includes two components. The first component involves 72 healthy adult volunteers in a blinded, randomized, placebo-controlled study [1]. This methodical approach demonstrates Satellos’s commitment to thoroughly evaluating SAT-3247’s safety and efficacy [GPT]. Results from this Phase 1B trial are anticipated in 2025 [4].
Market Impact and Future Outlook
This development represents a crucial milestone for Satellos Bioscience, which trades on the Toronto Stock Exchange under the symbol MSCL [2]. The FDA has granted SAT-3247 a rare pediatric disease designation to expedite its development [4], highlighting the potential significance of this treatment option for DMD patients [GPT]. As of December 11, 2024, the company’s shares were trading at $1.00 [2], as investors and the medical community closely monitor this development in the treatment of DMD.