Applied Molecular Transport announces FDA ODD granted to AMT-101

Applied Molecular Transport announced that the U.S. Food and Drug Administration, FDA, has granted Orphan Drug Designation, ODD, for AMT-101 in patients with pouchitis, an indication with significant unmet medical need and no current FDA-approved products. AMT-101 is an investigational, once-daily, GI-selective, oral fusion of IL-10 and AMT’s proprietary carrier molecule, which is also in development for the treatment of ulcerative colitis and rheumatoid arthritis. "Pouchitis is a severe end-stage complication of ulcerative colitis with serious symptoms that have a tremendous negative impact on quality of life, including excessive stool frequency, urgency, fecal incontinence and chronic pain," said Bittoo Kanwar, M.D., chief medical officer of AMT. "Following the results observed in our FILLMORE trial demonstrating compelling activity of AMT-101 in pouchitis, we look forward to continued collaboration with the FDA as we remain focused on Phase 3 advancement in this patient population. If ultimately approved, AMT-101 may be the first product approved in the U.S. to treat pouchitis and potentially improve the lives of patients suffering from this condition."