Satellos to Hold 8:00 a.m. Call on Pediatric BISCAMP Trial Strategy
Key Facts
Satellos said it will hold an investor call and audio webcast at 8:00 a.m. Eastern Time on November 6 to provide an update on the clinical and regulatory strategy for the BISCAMP trial in children with Duchenne muscular dystrophy. The announcement came on November 5 and set the topic of the call without announcing a change to the trial’s endpoints. The company had previously described the primary endpoints as including safety and tolerability and forazabadine’s effect on muscle strength, measured by dynamometry. The announced update therefore focuses on the study’s clinical and regulatory path, while the announcement included no stated change to the efficacy measure. This comes as the company awaits topline trial data in the first quarter of 2027.
Satellos describes BISCAMP as a Phase 2a study of forazabadine in ambulatory patients aged 7 years to under 10 years. The company says the study is active but no longer recruiting and includes 51 participants. The trial is randomized, double-blind and placebo-controlled, and studies two doses of the treatment over 12 weeks. The company had announced that enrollment was complete, with boys aged 7 to 10 years participating across 18 clinical sites in 7 countries. In September, it said the data could support discussions with the Food and Drug Administration about a potential accelerated development path for forazabadine.
Against the backdrop of interest in measuring muscle composition, Satellos reported in an interim update from its TRAILHEAD trial in adults that all four participants had a decline in MRI-measured fat fraction after six months. The average fell from 49.7% at baseline to 46.0% at month six, according to a company statement published in July. It also said average creatine kinase fell from 2130 units per liter at baseline to 1315 units per liter through month six. These figures concern four adults in an interim follow-up, while BISCAMP studies children; they provide background on the program and are not results from the pediatric trial. Forazabadine is an investigational drug and has not been approved by the U.S. Food and Drug Administration or any other regulator.
Satellos said on September 30 that it expects to announce topline BISCAMP data in the first quarter of 2027, after revising its earlier plan to allow time to assemble a more complete data set. The company said the study results could help it discuss a potential accelerated development path with the Food and Drug Administration. In an earlier regulatory development, it announced in June that the agency had granted the drug Fast Track designation for the treatment of Duchenne muscular dystrophy. In trading, the company’s shares, under the ticker MSLE, closed at $6.35 on November 5. No verified figures for the session’s trading range are available in the data provided.