-- Primary endpoint achieved --
LAINATE, Italy - July 4, 2007 - Cosmo Pharmaceuticals SpA (SWX:COPN) announced today positive preliminary results from its phase II/III study with CB-01-11 (Rifamycin SV MMX(tm)) in infectious diarrhoea. CB-01-11 is a broad spectrum, semi-synthetic antibiotic that is not absorbed when taken in tablet form. Through the use of Cosmo's MMX(tm) technology, which delivers the active ingredient into the colon, bacteria in the gastro intestinal tract that are important for vitamin synthesis are not sterilized. Given that it is practically not absorbed CB-01-11 is potentially applicable for the treatment of long term infections in the colon.
In the placebo controlled, randomized, double blind trial 120 patients in 8 sites in South Africa were treated with a 200mg tablet, 4 times per day for 3 days. The trial assessed non-inferiority versus Normix® (rifaximin) and the primary endpoint was the time from first ingestion of tablet to the last unformed stool. According to the preliminary reports CB-01-11 met this primary endpoint.
Mauro Ajani, CEO of Cosmo Pharmaceuticals, commented: "We are very encouraged about these preliminary results since many of the needs of patients are not adequately met with products currently on the market. Infections of the colon affect many more persons than colon inflammations and this is consequently a substantially larger market. We believe that our proprietary MMX(tm) technology will enable us to improve a range of products in colon infections and thus better meet patients' requirements."
Further analysis of the data is ongoing.
About Cosmo Pharmaceuticals
Cosmo is a speciality pharma company that aims to become a
global leader in optimised therapies for certain gastrointestinal
diseases. The company's proprietary clinical development
pipeline specifically addresses innovative treatments for IBD, such