Study of Fordadistrogene Movaparvovec in Early Stage Duchenne Muscular Dystrophy

Exclusion Criteria

• •Any of the following genetic abnormalities in the dystrophin gene: a. Any mutation (exon deletion, exon duplication, insertion, or point mutation) affecting any exon between exon 9 and exon 13, inclusive; OR b. A deletion that affects both exon 29 and exon 30; OR c. A deletion that affects any exons between 56-71, inclusive.
• •Positive test performed by Pfizer for neutralizing antibodies to AAV9.
• •Any prior treatment with gene therapy.
• •Any treatment designed to increase dystrophin expression within 6 months prior to screening (including, but not limited to, exon-skipping and nonsense read through).
• •Previous or current treatment with oral glucocorticoids or other immunosuppressive agents for the indication of DMD.
• •Abnormality in specified laboratory tests, including blood counts, liver and kidney function.