INN-108 is a novel oral small molecule therapeutic for Ulcerative Colitis (UC). Ulcerative Colitis is one of the two type of Inflammatory Bowel Diseases (IBD) which plagues up to 1.4 million individuals in the US alone. More than 80% of patients present with the mild to moderate form of Ulcerative Colitis. No innovation in the treatment of mild to moderate Ulcerative Colitis has occurred over the past few decades, except for several reformulations of 5-ASA/mesalamine. In spite of high failure rates of 5-ASA treatment, there are few alternatives other than steroids, before patients are treated with the very expensive anti-TNF biologics (AbbVie's HUMIRA® and J&J's REMICADE®). With the combination of an immunomodulator (approved since 1994), INN-108 could lead to a more efficacious drug than the 5-ASA/mesalamine formations alone.
For primary treatment of mild to moderate Ulcerative Colitis various formulations of 5-ASA/mesalamine are used. Currently approved treatments include various brands such as Lialda® by Shire Pharmaceuticals and Asachol HD® by Allergan. Sales of 5-ASAs add up to about $2 billion in the US alone.
INN-108 has successfully completed a phase 1 trial in the US in 24 subjects. INN-108 is in process of entering phase 2 trials for mild to moderate UC and an adult orphan indication.