Italy's Cosmo Pharmaceuticals has posted impressive preliminary data from a mid- to late-stage trial of its new drug for infectious diarrhoea.
The company noted that the Phase II/III study of CB-01-11 (rifamycin), a broad spectrum, semi-synthetic antibiotic that is not absorbed when taken in tablet form and is delivered using the firm’s MMX technology, involved 120 patients in eight sites in South Africa. According to the data, which assessed non-inferiority versus Normix (rifaximin), rifamycin reached its primary objective from first ingestion of the tablet to the last unformed stool, so given that it is “practically not absorbed, CB-01-11 is potentially applicable for the treatment of long term infections in the colon”, Cosmo said.
Mauro Ajani, Cosmo’s chief executive, noted that the firm is very encouraged about the 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 people than colon inflammations, he added, and is therefore a substantially larger market. “We believe that our MMX technology will enable us to improve a range of products in colon infections and thus better meet patients’ requirements,” Mr Ajani concluded.
Lehman Brothers issued a note saying that the product could now be partnered in Europe on the back of the positive data and in addition, “Cosmo will now likely commence a Phase III study for US regulatory filing." The brokers have forecasts peak sales of $120 million by 2013 and say the firm may be able to file for approval in Italy, Spain, Portugal, Greece and Germany before the end of this year. The MMX technology and is also used in Shire’s treatment for ulcerative colitis Lialda/Mezavant (mesalamine), which was approved in the USA in March.