Oscient Pharmaceuticals Corporation and the US Food and Drug Administration have agreed to a Special Protocol Assessment (SPA) for the continued clinical development of ramoplanin for the potential treatment of clostridium difficile-associated disease (CDAD). By reaching consensus on the SPA, the company has received guidance on the specific components of the phase III programme that, if completed successfully, would support regulatory approval for the indication.
"Securing agreement with the FDA on an SPA is an integral step in advancing our clinical development programme for ramoplanin. As the incidence and severity of CDAD cases has increased recently, the need for novel approaches for treating the condition has also risen. We hope to further demonstrate ramoplanin's potential through this pivotal phase III programme," stated Steven M. Rauscher, president and chief executive officer of Oscient Pharmaceuticals
According to the agreement reached with the FDA, Oscient will conduct two concurrent, pivotal phase III trials. The two non-inferiority studies will enrol, in each trial, approximately 490 patients diagnosed with CDAD, from centres in the United States, Canada and other parts of the world. Each patient will be randomly assigned to one of two treatment arms, in a double-blind, placebo-controlled regimen: ramoplanin 200 mg twice daily or vancomycin 125 mg four times daily for ten days. The primary endpoint will be the response rate at end of therapy, states a company release.
C. difficile is a spore-forming bacterium known to cause diarrhoea and colitis. Currently, it is estimated that 4, 00,000-5, 00,000 cases of CDAD occur each year in the US.
Oscient Pharmaceuticals' ramoplanin is an investigational new drug being studied for the treatment of Clostridium difficile-associated disease (CDAD). Ramoplanin has been shown to be bactericidal in vitro against Clostridium difficile.
Oscient Pharmaceuticals Corporation is a biopharmaceutical company that develops and commercialises novel therapeutics.