Shire : FDA Grants Orphan Drug Designation For Anti-MAdCAM Antibody SHP647

(RTTNews) - Shire plc (SHPG, SHP.L) said that the U.S. Food and Drug Administration granted Orphan Drug Designation to Shire's investigational anti-MAdCAM-1 antibody, SHP647 (formerly known as PF-00547659), for the treatment of pediatric patients with moderately to severely active ulcerative colitis or UC.

SHP647 is a fully human IgG2 monoclonal antibody targeting the mucosal addressin cell adhesion molecule-1 (MAdCAM-1).

Shire is currently investigating SHP647 in Phase 3 studies for the treatment of moderately to severely active UC in adults. Pediatric study plans with SHP647 are currently under discussion with health authorities.

Shire licensed SHP647 from Pfizer in June 2016, adding to Shire's established and leading gastrointestinal (GI) portfolio. MAdCAM-1 plays a role in leukocyte trafficking in the GI tract and also appears to facilitate excessive lymphocyte infiltration under conditions of chronic GI inflammation. SHP647 directly targets MAdCAM-1, and inhibits a4ß7 integrin binding to human MAdCAM-1 with high affinity and selectivity.