Regenxbio posts mixed Phase III data on RGX-202
US biotech Regenxbio (Nasdaq: RGNX) announced top-line and interim functional data from the pivotal Phase III portion of the Phase I/II/III AFFINITY DUCHENNE trial of RGX-202, a potential best-in-class gene therapy for Duchenne muscular dystrophy (DMD).
The trial met its primary endpoint with high statistical significance (p<0.0001), with 93% of participants reaching at least 10% microdystrophin expression at Week 12 (n=30). Additionally, RGX-202 demonstrated statistically significant correlation between microdystrophin expression and interim functional improvement.
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