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news.Cubist Pharmaceuticals, a biopharmaceutical company, has started dosing in the first-in-human clinical trial with CB-183,315, an investigational antibacterial drug candidate intended to treat patients with a severe and sometimes life-threatening diarrhea caused by Clostridium difficile known as C difficile associated diarrhea, or CDAD.
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The current Phase I trial is the first time CB-183,315 has been given to humans and is designed to evaluate the safety and pharmacokinetics of single escalating oral doses of CB-183,315 in normal human subjects.
If the results of the Phase I safety trials are positive, Cubist plans to conduct Phase II studies to examine the safety and efficacy of CB-183,315 in C difficile infected patients.
CB-183,315 is a novel antibacterial agent discovered by Cubist scientists that has potent bactericidal activity against C difficile bacteria and has demonstrated preclinical safety and efficacy in animal models. The investigational new drug for CB-183,315 was submitted to the FDA in December 2008.
Mike Bonney, president and CEO of Cubist, said: The beginning of this Phase I trial is an important moment for Cubist as it marks the first time that a drug that originated in our labs has entered a Phase I trial. We are committed to addressing the high unmet medical need that exists for a therapy to defeat the increasingly virulent strains of CDAD.