Assembly Biosciences US

A randomized, double-blind, placebo-controlled, multi-center phase 1b study to evaluate the safety, efficacy and microbiological response of orally administered ABI-M201 in subjects with mildly-to-moderately active Ulcerative Colitis with ongoing mesalamine treatment

  • Male or female, 18-70 with a diagnosis of Ulcerative Colitis for at least 3 months prior to screening
  • Active disease with at least 15cm of involved colon, mayo score 3-8
  • Must be on oral melsalamine > 2.4 g/day for at least four (4) weeks before screening
  • No ongoing treatment or failed prior treatment with methotrexate, azathioprine, 6-mercaptopurine, cyclosporine, tofacitinib, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, tacrolimus (FK-506), or biologics (e.g., TNF-alpha-antagonists, anti-integrin therapies, agents targeting IL-12 or IL-23, etc.)
  • ABI-M201 bacterial strains were isolated from the stool of healthy human donors who were extensively screened to verify absence of infectious agents and other disease states