PepGen Says FDA Issues Clinical Hold On Phase 2 Study For PGN-EDO51 In Duchenne Muscular Dystrophy

PepGen

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(RTTNews) - Biotechnology company PepGen Inc. (PEPG) announced Monday 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.

CONNECT2 is PepGen's Phase 2 multinational, double-blind placebo-controlled, multiple ascending dose, 25-week clinical trial of PGN-EDO51 in patients with DMD. The study is open in the United Kingdom.

PepGen is a clinical-stage biotechnology company advancing the next-generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases.

PGN-EDO51, PepGen's clinical candidate for the treatment of DMD, utilizes the Company's proprietary Enhanced Delivery Oligonucleotide (EDO) technology to deliver a therapeutic phosphorodiamidate morpholino oligomer (PMO) that is designed to target the root cause of this devastating disease.