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news.Biotechnology company Avaxia Biologics has received AVX-470 investigational new drug (IND) application clearance for the treatment of ulcerative colitis from the FDA.
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The bovine anti-tumor necrosis factor polyclonal antibody is based on Avaxia’s oral antibody platform and is thus directly delivered to the GI tract where the inflammation occurs.
Company anticipates beginning AVX-470 Phase 1b trial in patients with active ulcerative colitis shortly.
Avaxia CEO Barbara Fox said IND clearance enables the advancement of AVX-470 into clinical development.
"Because AVX-470 is delivered directly to the GI tract, it has a lower potential for systemic immunosuppression than injectable anti-TNF therapies while potentially retaining the proven benefits of anti-TNF antibody therapy for inflammatory bowel disease," Fox added.