Recently listed, Satellos Bioscience Inc. (NASDAQ:MSLE) on Wednesday reported six-month interim data from its ongoing TRAILHEAD study of SAT-3247 for Duchenne muscular dystrophy (DMD)
The data showed that SAT-3247-treated DMD patients experienced improvements in muscle composition and upper limb activity while maintaining stable strength.
The company also said the drug continued to demonstrate a favorable safety and tolerability profile, supporting its continued clinical development.
The TRAILHEAD study is expected to enroll up to 30 male participants.
SAT-3247 Shows Improvements In Muscle Composition And Upper Limb Activity
The interim analysis included four adults between the ages of 21 and 28 who had previously completed the Phase 1a/b CL-101 study. Participants received SAT-3247 for an average of 186 days.
MRI assessments showed that all four participants experienced reductions in muscle fat fraction.
Mean muscle fat fraction improved 3.7%, declining from 49.7% at the TRAILHEAD baseline to 46.0% after six months, suggesting improvements in muscle composition.
The company also reported gains in upper limb activity.
All participants recorded higher TE99C scores, a measure of maximum upper limb effort captured using the SYSNAV Syde wearable device.
Average TE99C increased about 34%, rising from a CL-101 baseline of 16.1 joules per kilogram to 21.6 joules per kilogram at the six-month assessment.
Safety Profile Remains Consistent After Six Months Of Treatment
Satellos said SAT-3247 remained well-tolerated throughout the study.
Measures of upper extremity strength, including handgrip and handheld dynamometry assessments of the elbow and shoulder, remained stable through six months.
The company added that the nearly twofold improvement in handgrip strength observed during the earlier 28-day CL-101 study was maintained throughout the TRAILHEAD follow-up period.
Additional Biomarkers And Functional Measures Support Interim Findings
Additional endpoints also showed favorable trends. Mean creatine kinase (CK), a biomarker of muscle damage, declined 38% from baseline through month 6 of TRAILHEAD.
Performance of the Upper Limb 2.0 scores increased by one point in two participants and remained stable in the other two.
MSLE Stock Price Activity: Satellos Bioscience shares were up 9.76% at $9.01 at the last check on Wednesday, according to Benzinga Pro data.
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