Benzinga | Jan 6, 2022 07:08AM EST

REGENXBIO Announces FDA Clearance Of IND For Clinical Trial Of RGX-202, A Novel Gene Therapy Candidate For Duchenne Muscular Dystrophy

* Potential one-time gene therapy for the treatment of Duchenne includes a novel, optimized microdystrophin transgene and REGENXBIO's proprietary NAV(r) AAV8 vector

* Innovative trial design, including comprehensive immunosuppressive regimen, to evaluate safety and optimal dose

* cGMP process material made at commercial-scale to be used throughout clinical development of RGX-202

* REGENXBIO expects to initiate trial in the first half of 2022