INN-108 is a novel oral small molecule therapeutic for mild to moderate Ulcerative Colitis. Ulcerative Colitis is one of the two most common types 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 reformulations of 5-ASA/mesalamine, in spite of high failure rates of 5-ASA treatment. With the combination of an immunomodulator (approved since 1994), INN-108 could lead to a more efficacious drug than 5-ASA/mesalamine alone.
MARKET OPPORTUNITY
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 Actavis. Sales for 5-ASA products add up to approximately $2 billion in the US alone. This figure excludes generic sales of 5-ASA/mesalamine which, at branded prices, would nearly double the branded market sales.
REGULATORY STATUS
INN-108 has successfully cleared all pre-clinical work and phase I trials and is now entering phase II trials.