AGI-022
is in clinical development for the remission and
treatment of Ulcerative Colitis (UC)
AGI-022 is a delayed/controlled release oral formulation of 4-aminosalicylic acid ("4-ASA") which is being developed by AGI for the induction and maintenance of remission of mild to moderate ulcerative colitis ("UC").
Inflammatory bowel disease is a chronic inflammatory disorder of the digestive tract and is manifest as two distinctive and overlapping forms, Crohn's disease and ulcerative colitis. Although both forms share many characteristics, they are regarded and treated as separate diseases. UC is a chronic, recurrent, relapsing and remitting inflammatory disease of the colon and/or rectum.
The prevalence of UC is estimated at almost 1 million patients across the seven major pharmaceutical markets (US, Japan, Germany, UK, France, Italy and Spain) and the incidence of new cases in these countries is estimated at 50,000 per annum. The aminosalicylate class of anti-inflammatory drugs is used to treat UC and many of those currently marketed are presented as modified release oral formulations. Global annual sales of aminosalicylate drug products in IBD are currently estimated to be at least US$700 million annually. 4-ASA is an aminosalicylate drug which is not currently available in an oral modified release form for the treatment of UC.
AGI has completed a human pharmacokinetics trial to demonstrate the potential of AGI-022 in the treatment of ulcerative colitis where the new formulation has achieved the desired pharmacokinetic profile. AGI-022 is a reformulation of an existing approved drug, 4-ASA, and this product candidate is now ready to progress to planning for a Phase III programme for the treatment of ulcerative colitis.
|
|
