Fast Track Designation for ALV003 for Celiac Disease

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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