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PepGen Inc. Provides Update on Planned Initiation of Phase 1 Study of PGN-EDODM1 in Myotonic Dystrophy Type 1
BOSTON, June 13, 2023 (GLOBE NEWSWIRE) -- PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide
About this update from Pepgen Inc.
[{"type":"text","content":"BOSTON, June 13, 2023 (GLOBE NEWSWIRE) -- PepGen Inc. (Nasdaq: PEPG), 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, today announced that while it awaits receipt of an official clinical hold letter from the U.S. Food and Drug Administration (FDA), the Company is withdrawing its prior guidance with respect to the timeline for initiating a Phase 1 study of PGN-EDODM1 in patients with myotonic dystrophy type 1 (DM1) in the first half of 2023 in any geography. “After careful consideration, we decided to pause additional regulatory filings for clearance to initiate a Phase 1 study of PGN-EDODM1 in order to address the official hold letter once received from the FDA,” said James McArthur, Ph.D., President and CEO of PepGen. “People living with DM1 are eager for innovative, potential new treatment options for this serious disease, and transparency with that community and PepGen’s shareholders is always a top priority for our team. We will continue to work closely with the FDA to lift the clinical hold whilst we remain fully committed to initiating a Phase 1 study of PGN-EDODM1 as quickly as feasible. We also remain very focused on advancing our Phase 2 CONNECT1-EDO51 study in our lead program in Duchenne muscular dystrophy, which was cleared to proceed last month by Health Canada.” About PepGen PepGen Inc. 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. PepGen’s Enhanced Delivery Oligonucleotide, or EDO, platform is founded on over a decade of research and development and leverages cell-penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics. Using these EDO peptides, we are generating a pipeline of oligonucleotide therapeutic candidates that are designed to target the root cause of serious diseases. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,”...