Oscient Pharmaceuticals Corporation has completed enrolment of an open-label, phase II clinical trial of Ramoplanin, an investigational oral antibiotic being developed for the treatment of Clostridium difficile-associated diarrhoea (CDAD), according to a company release.

Following completion of the last patient's course of therapy and follow-up, the Company will conduct its analysis of the data and plans to release preliminary results. The Company anticipates submitting full results for publication or presentation at an upcoming medical conference. Based on the results observed to date in the trial, the Company expects to seek FDA authorization to commence a phase III programme for CDAD by the end of this year. Ramoplanin has Fast Track status from the FDA for this indication.

This open-label, three-armed, non-inferiority study was designed to assess whether oral Ramoplanin (200 mg or 400 mg twice daily) is at least as effective as oral vancomycin (125 mg four times daily), the only FDA-approved treatment for CDAD. The study enrolled 87 patients across 24 US sites. Per protocol, the test-of-cure visit occurs one to two weeks after the end of therapy, although patients are followed for an additional one to two weeks, or up to 28 days after the last dose of study drug. The trial was designed to examine the safety and efficacy of Ramoplanin in treating mild, moderate and severe cases of CDAD. The dose for the phase III programme will be selected based on the results of the phase II study.

Clostridium difficile-associated diarrhoea is the most common type of hospital-acquired diarrhoea, with approximately 400,000 cases per year reported in the US. C. difficile, a spore-forming bacterium, is readily spread from person to person, especially in hospitals and nursing homes.

Oscient Pharmaceuticals' Ramoplanin is an investigational new drug in clinical development for the prevention, treatment and control of serious hospital-based infections.

Oscient Pharmaceuticals Corporation, which was formed through the merger of Genome Therapeutics and Genesoft Pharmaceuticals, is a biopharmaceutical company committed to the clinical development and commercialization of novel therapeutics to address unmet medical needs.