Sanofi Pasteur begins Phase III trials of investigational drug against CDI

Sanofi Pasteur announced on Monday that it will begin Phase III clinical trials of its Cdiffense program, which seeks to develop an investigational vaccine against the leading cause of healthcare-associated infections worldwide Clostridium Difficile.

C. diff is a spore-forming bacterium which causes recurring intestinal disease, primarily targeting the elderly. Clostridium Difficile infection is highly contagious and has a high risk of causing an outbreak in a hospital or nursing home, where the elderly population is high and lives close together.

CDI is the leading life-threatening HAI in the world, taking the lives of 8 to 15 percent of those infected. In the United States, 14,000 people die each year from CDI. The disease costs the U.S. health care sector $4.8 billion annually.

The C. diff investigational vaccine is intended to produce an immune response to specifically destroy the toxins a CDI causes in the body, which generally lead to stomach inflammation and diarrhea. The vaccine is also intended to help prevent recurring infection.

"With the emergence of difficult-to-manage strains of C. diff, CDI has become more frequent, more severe and more difficult to treat in recent years, raising concerns about how to control it and prevent transmission," Senior Vice President for Research & Development at Sanofi Pasteur John Shiver said. "Vaccination could be an efficacious, cost-effective and important public-health measure to protect individuals from C. diff."