by: Parent Project Muscular Dystrophy
We are disappointed to learn the news that Roche has made the difficult decision to terminate their Phase 2 SHIELD DMD study evaluating satralizumab for bone health in Duchenne.
According to Roche, this decision was reached after careful consideration of the program’s path forward and reflects a combination of factors, including study timelines and the feasibility of meeting regulatory expectations.
Importantly, this decision is not due to any new or unanticipated safety risks, nor new efficacy or quality concerns. With very low recruitment at this point in the study, Roche shared that there is not a realistic path to regulatory approval, therefore continuing the study would place an undue burden on trial families, sites, and the broader community.
The SHIELD DMD study (NCT06450639) has enrolled fewer than 30 boys across six countries: the United States, Denmark, Italy, Poland, Spain, and Ukraine. In the United States, eight individuals are currently enrolled.
Although development of satralizumab for bone health in Duchenne will close after the interim analysis, Roche has committed to sharing the interim study data at a future medical conference and back to the community to help advance understanding of bone health in Duchenne.
PPMD recognizes how difficult news like this can be, particularly for families who chose to participate in SHIELD DMD. We are grateful to the participants and families who contributed to this study, the clinical teams that supported them and Roche for their commitment to sharing data back to the community.
Bone health remains a critical component of comprehensive Duchenne care. We will continue to work with partners across research and care to address unmet needs and ensure families are informed and supported as the field moves forward.
