Friday, February 13, 2009

Cubist begins human testing of severe diarrhea drug

By Mass High Tech staff

Cubist Pharmaceuticals Inc. has announced the start of Phase 1 First-in-Human clinical trials of its antibacterial drug treatment, CB-183,315, to treat C. difficile, a potentially life-threatening diarrhea, also known as CDAD. The drug has already shown progress, by preclinical safety and efficacy measures, in animal testing.

The human clinical trials will consist of oral doses of Cubist’s CB-183,315, in increasing measurements on healthy patients, to test safety and pharmacokinetics. If Phase 1 trials show positive results, the company said it will open up Phase 2 trials to test safety in patients infected with CDAD.

CDAD often occurs in connection with antibiotic treatment used to prevent “common community and hospital acquired infections,” Cubist (Nasdaq: CBST) officials reported. The company said in a statement that reported cases of CDAD tripled in the time period from 1996 to 2005.

Lexington-based Cubist said that it filed an Investigational New Drug application with the U.S. Food and Drug Administration for CB-183,315, in December.

Earlier this week, the company announced plans to file a patent infringement lawsuit against Teva Parenteral Medicines Inc., after receiving notice that Teva plans to issue a generic drug version of Cubist’s daptomycin for injection.

Cubist reported a 45 percent jump in third quarter 2008 revenue over the same period the previous year. Cubist had $76.3 million in Q3 2007 compared with $110.6 million in 2008.