Innovate Biopharmaceuticals has announced that its oral therapy INN-108, proposed for the treatment of pediatric ulcerative colitis, has been granted Orphan Drug designation.
INN-108 is a novel oral molecule composed of two moieties; mesalamine/5-ASA and 4-aminophenylacetic acid (4-APAA). As the two agents are covalently azo-bonded, enzymatic separation only occurs in the colon. Early Phase 1 data has indicated that the treatment may be more efficacious than mesalamine/5-ASA treatments alone.
Mesalamine/5-ASA is currently approved by the Food and Drug Administration (FDA) for ulcerative colitis, while 4-aminophenylacetic acid (4-APAA), an immunomodulatory agent, is approved in Japan to treat rheumatoid arthritis.
After completing a Phase 1 trial in both healthy adults and adults with ulcerative colitis, the company will begin a Phase 2 trial in 2018.
For more information visit Innovativebiopharma.com.