Epic Bio Presents Compelling Preclinical Data Supporting Clinical Initiation of EPI-321 for FSHD

– NHP studies demonstrate EPI-321’s favorable safety and pharmacokinetic profile –

– IND and CTA applications planned for 2023 –

Excerpt from the Press Release:

SOUTH SAN FRANCISCO, Calif., June 16, 2023 (GLOBE NEWSWIRE) — Epic Bio, a biotechnology company developing therapies to modulate gene expression using compact, non-cutting dCas proteins, today presented new non-human primate (NHP) data supporting the clinical advancement of EPI-321 for the treatment of facioscapulohumeral muscular dystrophy (FSHD). The data were presented in a poster at the FSHD International Research Congress being held June 15-16, 2023, in Milan, Italy.

“We are very encouraged by the totality of preclinical data on EPI-321, indicating this therapy can reverse disease pathophysiology in FSHD with a high degree of safety. These results were made possible via Epic Bio’s unparalleled Gene Expression Modulation System (GEMS) platform, which overcomes limitations of other types of genetic medicines,” said Amber Salzman, Ph.D., chief executive officer of Epic Bio. “We are working to expeditiously bring this therapy to the clinic to provide a much-needed treatment option for patients with FSHD.”

New data presented at the conference detail the safety, pharmacokinetics, and biodistribution of EPI-321 in NHPs. No adverse events, liver toxicity, or severe immune response were observed within three months post-delivery of EPI-321 at both low and high doses. EPI-321 also showed favorable pharmacokinetics and biodistribution, with tissue-specific mRNA analyses indicating robust and specific expression of the cargo DNA in skeletal muscle.

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