HHS signs $17.7 million contract for development of countermeasures for bioterror
The two-year contract will fund the advanced research and development of an antibiotic that could treat children infected with tularemia, community-acquired bacterial pneumonia and anthrax. The contract will support studies required to request U.S. Food and Drug Administration approval of solithromycin.
"The needs of special populations including children are paramount in public health emergency preparedness," Robin Robinson, the director of BARDA, said. "The development of this new antibiotic could help address a gap in our nation's preparedness and could bolster clinicians' ability to treat drug-resistant bacterial infections, which represent a growing public health threat."
If approved, solithromycin would be the first orally administered antibiotic approved in decades to treat children with community-acquired bacterial pneumonia.
Cempra will conduct studies of the drug's use in treating tularemia or anthrax under the FDA's Animal Efficacy Rule, which allows efficacy findings from adequate and well-controlled animal studies to support FDA approval when it is not ethical or feasible to conduct human trials.
Solithromycin previously demonstrated efficacy in adults with uncomplicated urogenital gonorrhea and community-acquired bacterial pneumonia. Cempra began a global multi-center clinical trial of the orally administered drug in late 2012. When the study is complete in the first half of 2014, the company will use the data to determine future activities supported under the contract.