Initiation of AFFINITY DUCHENNE™ trial of RGX-202 for the treatment of Duchenne will be delayed.

This January, we shared the news that REGENXBIO received clearance from the U.S. FDA and would soon be launching a trial of RGX-202, their targeted therapy for improved resistance to muscle damage associated with Duchenne.

Today in a press release, REGENXBIO announced an update for the community regarding its gene therapy trial:

We have taken proactive measurements that will result in the delayed dosing of the first patient in the Phase I/II AFFINITY DUCHENNETM trial due to an unexpected observation in the final stages of manufacturing at one of its third-party manufacturers.  Work preparing for initiation of the trial continues, including readying clinical trial sites and manufacturing additional clinical supply for the trial.  REGENXBIO anticipates dosing the first patient in the trial in the first half of 2023.”

More information on this development along with other updates from REGENEXBIO can be found in the press release here.

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