FDA issues clinical hold notice to PepGen on IND app for CONNECT2-EDO51 trial

PepGen (PEPG) announced that the Company received a clinical hold notice from the U.S. Food and Drug Administration FDA regarding its Investigational New Drug IND application to initiate the CONNECT2-EDO51 clinical trial in patients with Duchenne muscular dystrophy DMD . The FDA indicated they will provide an official clinical hold letter to the Company within 30 days…”We intend to work closely with the FDA to address their questions on our application to initiate CONNECT2 as expeditiously as possible,” said Paul Streck, MD, MBA, Head of R&D of PepGen. “Our open-label CONNECT1-EDO51 multiple ascending dose study of PGN-EDO51 in boys and young men living with DMD continues as planned in Canada. We have completed enrollment of the 10 mg/kg dose cohort; all four patients in this cohort have received at least one dose.”