Pediatric Ulcerative Colitis Therapy Granted Orphan Drug Status

Avaxia Biologics announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to its investigational therapy, AVX-470 for the treatment of pediatric ulcerative colitis. AVX-470 is an orally administered gut-targeted anti-TNF antibody.

RELATED: Ulcerative Colitis Treatments

In December 2013, Avaxia completed a first-in-human clinical trial of AVX-470 in ulcerative colitis patients. The Phase 1b trial was a double-blind, placebo-controlled, ascending dose study of AVX-470 in active ulcerative colitis. Three different dose levels of AVX-470 were given over 28 days. A total of 36 patients were treated in the trial, with nine patients receiving placebo and 27 receiving the drug. The primary objective of the trial was to evaluate the safety and tolerability of AVX-470.

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