Oscient, FDA agree on design of phase 3 studies of Ramoplanin to treat clostridium difficile-associated disease

By E. Janene Geiss

Philadelphia, Dec. 21 - Oscient Pharmaceuticals Corp. and the U.S. Food and Drug Administration have agreed to a Special Protocol Assessment for the continued clinical development of Ramoplanin for the potential treatment of clostridium difficile-associated disease.

By reaching consensus on the SPA, the company said it has received guidance on the specific components of the phase 3 program that, if completed successfully, would support regulatory approval for the indication, according to a company news release.

"As the incidence and severity of [clostridium difficile-associated disease] 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 3 program,"Steven M. Rauscher, president and chief executive officer, said in the release.

According to the agreement, Oscient said it will conduct two concurrent, pivotal phase 3 trials.

The two non-inferiority studies will enroll in each trial about 490 patients diagnosed with clostridium difficile-associated disease from centers 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, officials said.

Clostridium difficile is a spore-forming bacterium known to cause diarrhea and colitis. In the past, clostridium difficile-associated disease has been mainly a concern in patients who have had recent antibiotic therapy or are hospitalized. In recent years, the incidence and severity of clostridium difficile-associated disease has increased and anecdotal cases are being reported where no antibiotic therapy or exposure to hospitals has occurred.

Currently, it is estimated that 400,000 to 500,000 cases of clostridium difficile-associated disease occur each year in the United States and generates an estimated $1.1 billion in hospital health care costs, officials said.

Oscient is a Waltham, Mass., biopharmaceutical company committed to the clinical development and commercialization of novel therapeutics to address unmet medical needs

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