Recently, Cubist Pharmaceuticals (CBST) began a mid-stage trial of one of its pipeline candidates, CB-183,315. The drug is being studied to treat patients suffering from diarrhea caused by Clostridium difficile also known as C. difficile-associated diarrhea or CDAD. The phase II trial is likely to enroll over 200 patients at multiple locations in the U.S and Canada.
The trial is designed to evaluate the safety and effectiveness of CB-183,315 compared to Vancocin. CB-183,315 will be studied in two dosage forms – 125 mg twice daily and 250 mg twice daily compared to Vancocin in a 125 mg dose to be administered four times a day for over a period of 10 days.
While we are pleased with the development in the company’s pipeline, we remain concerned about the outcome of the forthcoming trials since Cubist recently suffered a major setback with one of its pipeline candidates. The company had to stop a mid-stage trial of CB-500,929 (ecallantide), which was being studied for lowering blood loss in patients undergoing cardiac surgery using cardiopulmonary bypass.
Currently, Cubist earns a major portion of its revenues from Cubicin, which recorded $537.8 million in global sales in 2009. The drug is meant for the treatment of infection caused by gram-positive bacteria including methicillin-resistant Staphylococcus aureus (S. aureus).
In order to strengthen its pipeline, in Dec 2009, Cubist decided to acquire a privately held biopharmaceutical company Calixa Therapeutics. This deal brought with it Calixa’s lead compound CXA-201 (containing CXA-101), an intravenous treatment in mid-stage trial for the treatment of urinary tract and intra-abdominal infections caused by Pseudomonas aeruginosa.
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