BARDA (Biomedical Advanced Research and Development Authority) has awarded Cempra, a clinical-stage pharmaceutical company focused on differentiated antibiotics, with a five year contract valued up to $58 million for the development of solithromycin to treat infections in pediatric populations and for the treatment of infections by bioterror threat pathogens.
Solithromycin, Cempra's lead product candidate, is a fourth generation macrolide antibiotic in the fluoroketolide family that is currently in phase III development for community-acquired bacterial pneumonia (CABP) in adults.
"We are delighted that BARDA has recognized solithromycin as a potentially safe and effective treatment for the pediatric population," said Prabhavathi Fernandes, Ph.D., CEO of Cempra. "Macrolides have traditionally been favored for use in pediatrics because of their safety and efficacy. Solithromycin's approval would be the first orally administered antibiotic approved in decades, and azithromycin (Zithromax or Z-Pak) was the last macrolide approved, which was in 1991. We view BARDA's funding of this project as recognition of the potential of solithromycin to have broad utility in all age groups."
The upfront contract is for a two-year base period with guaranteed funding of $17.7 million and is extendable up to five years bringing the value of the total contract to $58 million. The contract is expected to fund a variety of activities that are planned to lead to the pediatric as well as the Animal Rule New Drug Applications (NDA) for use of solithromycin against bioterror threat pathogens.
The full funding, if received, will support phase I, phase II and the majority of the phase II/III studies on a pediatric oral suspension, oral capsules and the intravenous formulation for CABP. The contract should also fund non-human primate pilot studies of activity against biothreat pathogens, anthrax and tularemia, placing Cempra's lead product on the pathway to other indications.
This project will be funded in whole or in part with federal funds from the department of health and human services, office of the assistant secretary for preparedness and response, BARDA.