A Phase 1/2/3 Open-label Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacodynamics, and Pharmacokinetics of Intravenous RGX-202 Gene Therapy in Males With Duchenne Muscular Dystrophy (DMD)
Latest Information Update: 13 Nov 2025
At a glance
- Drugs RGX 202-REGENXBIO (Primary)
- Indications Duchenne muscular dystrophy
- Focus Adverse reactions; First in man; Pharmacodynamics; Registrational
- Acronyms AFFINITY DUCHENNE
- Sponsors REGENXBIO
Most Recent Events
- 06 Nov 2025 According to a REGENXBIO media release, the data from the trial were presented at the International Congress of the World Muscle Society
- 30 Oct 2025 According to a REGENXBIO media release, the pivotal portion of the multi-center, open-label Phase I/II/III AFFINITY DUCHENNE trial completed enrollment of 30 participants in October 2025; the company expects sharing topline pivotal data in early Q2 of next year
- 29 Sep 2025 According to a REGENXBIO media release, the data from the trial will be presented at the International Congress of the World Muscle Society