REGENXBIO Initiates P-I/II Trial of RGX-202 for the Treatment of Duchenne Muscular Dystrophy
Shots:
- The company initiated the P-I/II dose evaluation & dose expansion trial (AFFINITY DUCHENNE) evaluating RGX-202 (IV) in patients with DMD
- The (AFFINITY DUCHENNE) trial EPs include safety, immunogenicity assessments, PD & PK measures of RGX-202, incl. microdystrophin protein levels in muscle, strength and functional assessments, incl. the NSAA & timed function tests
- Patient enrolment also undergoes in the (AFFINITY BEYOND) observational screening study & the primary objective is to evaluate the prevalence of AAV8 Abs for Duchenne in patients aged ~12yrs. RGX-202 is intended to support the targeted delivery & expression of genes throughout skeletal & heart muscle using NAV AAV8 vector
Ref: PRNewswire | Image: REGENXBIO
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