HHS sponsors Phase III clinical trial on broad spectrum antibiotic

The U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) announced its support today of the Phase III clinical trial of the broad spectrum antibiotic Ceftobiprole.

ASPR's Biomedical Advanced Research and Development Authority (BARDA) signed a $20 million agreement with Basilea Pharmaceutica International Ltd. to conduct the clinical trial. The 18-month agreement can be extended by BARDA for an additional three years with a total payment of up to $100 million. The Phase III study is required for U.S. Food and Drug Administration (FDA) approval of the drug.

Ceftobiprole will be tested as a treatment for Gram-negative and Gram-positive infections. Among the infections caused by these bacteria are Pseudomonas aeruginosa and staph infections such as MSSA and MRSA (Methicillin-Susceptible and Methicillin-Resistant Staphylococcus aureus, respectively). The antibiotic is also a potential treatment for tularemia. Tularemia is also known as Pahvant Valley plague and rabbit fever. It is considered a potential weapon in bioterrorism, since it can cause deadly pneumonia infections.

“HHS is working aggressively to address the nation’s needs in public health emergencies,” BARDA Acting Director Dr. Richard Hatchett said. “Those needs include treatments for antibiotic-resistant bacteria and to strengthen our defense against bioterror threats; by identifying a number of products that can address both needs, BARDA’s biodefense investments will yield important public health dividends.”