PepGen announced that the UK Medicines & Healthcare products Regulatory Agency, MHRA, has authorized its Clinical Trial Application, CTA, to initiate the CONNECT2-EDO51 Phase 2 clinical trial of PGN-EDO51 in patients with Duchenne muscular dystrophy, DMD, amenable to an exon 51-skipping approach. “We are excited to take the next step forward in our development of PGN-EDO51, which we believe to be a potentially transformative investigational candidate for people living with DMD and are pleased the MHRA authorized our CTA. We believe this study, together with the data generated in our ongoing CONNECT1-EDO51 trial, could potentially support accelerated approval of EDO51, subject to alignment with regulators,” said James McArthur, Ph.D., President and CEO of PepGen. “We are grateful to continue our work with the DMD community to develop this therapy.”
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