New diarrhoea drug adds to IBD arsenal

The company has applied its technology to rifamycin, an antibiotic used to treat traveller's diarrhoea, and could prove to be a significant addition to the arsenal of treatments available to treat long-term colon infections. Tablets formulated with Cosmo's MMX technology are coated with pH resistant acrylic copolymers which delay the release of the active ingredient until the tablet reaches the indicated intestinal location where the controlled dissolution begins. Protected from the harsh environment of the upper digestive tract via an array of matrices and protecting layers, the active ingredient can then be released in a controlled fashion throughout the length of the colon. According to the company, this controlled release simplifies application for patients and also allows for the topical application of the active ingredients to the whole bowel surface that is affected. The rifamycin product, currently going by the label CB-01-11, is a broad spectrum, semi-synthetic antibiotic. Through the use of the MMX technology, the antibiotic is delivered straight to the colon, which means that bacteria in the gastronintestinal tract (important in vitamin synthesis) are not sterilised. The fact that CB-01-11 is not absorbed when taken in tablet form also means that the product could be used in treatment of long-term infections of the colon. The preliminary Phase II/III data showed that the Cosmo formulation performed successfully when compared to Normix (rifaximin), when assessing the time from first ingestion to the last unformed stool. Cosmo specialises in treatments for gastrointestinal diseases and has several other products in its pipeline. However, the company has noted the fact that infections of the colon affect many more people than inflammation of the colon, and this is therefore a larger market for the company to target. The company's first MMX product hit the market in March this year, a treatment for ulcerative colitis. Lialda/Mezavant (mesalamine) is licensed globally to Giuliani and Shire, and can significantly reduce the number of tablets patients have to take each day to treat their bowel disease. In its first few weeks on the US market, the product captured 1.2 per cent of the oral mesalamine market, and is expected to hold 9 per cent by the end of the year.