Sarepta’s Phase I/IIa balloon (NCT03375164) of AAVrh74.MHCK7.micro-Dystrophin was placed on ytic authority afterwards a “trace” bulk of DNA fragment alike in a accomplishment lot of research-grade raw actual plasmid supplied by an bearding third-party manufacturer.
Today, Sarepta said its ytic authority was aerial afterwards aing with its accomplice in the ytic trial, Nationwide Children’s Hospital, to advance and abide an activity plan to the FDA, including an ysis of the plasmid supplier and a charge to use GMP-s plasmid for all approaching assembly lots.
“Thanks to the alive and accelerated assignment of my Sarepta colleagues and Nationwide Children’s Hospital in accumulation and appointment a complete acknowledgment and the alive appraisal by the FDA in reviewing the acknowledgment and removing this ytic hold, we accept been able to abode the ytic authority in almanac time and after adjournment to this greatly important ytic program,” Sarepta admiral and CEO Doug Ingram stated.
“Our focus now is on affair with the [FDA] to booty advice and accretion alignment about what we achievement to be our allotment balloon for our micro-dystrophin affairs and accomplishing our ambition of basic that balloon by anniversary 2018,” Ingram added.
The balloon is one of two ytic studies of AAVrh74.MHCK7.micro-Dystrophin listed on ClinicalTrials.gov. Nationwide Children’s is additionally administering a Phase I double-blind, randomized controlled abstraction (NCT02710500) assessing the gene ysis as a ysis for dysferlinopathies, with absolute intramuscular bang of rAAVrh.74.MHCK7.DYSF.DV gene agent to the extensor digitorum brevis beef (EDB). The balloon was alive but not recruiting patients as of the best contempo update, acquaint July 18.
A ages beforehand on June 19, Sarepta trumpeted absolute basic ytic abstracts for AAVrh74.MHCK7.micro-Dystrophin in the Phase I/IIa study. Sarepta appear that all three patients showed able-bodied micro-dystrophin announcement in beef abstinent by all methods, as able-bodied as cogent decreases in the levels of serum creatine kinase (CK), an agitator biomarker acerb associated with beef accident acquired by DMD. The beggarly abridgement of CK was over 87% at day 60.
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