Alvine Pharmaceuticals announced that ALV003 received Fast Track designation from the FDA for the potential treatment of patients with celiac disease.

Alvine is currently conducting Phase 2 clinical trials with ALV003.

ALV003 is an orally administered mixture of two recombinant gluten-specific proteases, a cysteine protease (EP-B2) and a prolyl endopeptidase (PEP). ALV003 targets gluten and degrades it into small fragments, which, in vitro, diminishes its immunogenicity. ALV003 is being developed as a potential treatment for celiac disease patients in conjunction with a gluten-free diet.

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