Cempra to develop antibiotic solithromycin for pediatric use and biodefense

The fourth generation macrolide antibiotic is currently in Phase 3 development for community-acquired bacterial pneumonia (CABP) in adults.

Cempra chief executive officer Prabhavathi Fernandes said BARDA has recognized solithromycin as a potentially safe and effective treatment for the pediatric population.

"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," Fernandes added.

"We view BARDA’s funding of this project as recognition of the potential of solithromycin to have broad utility in all age groups."

With a possible extension to five years, the upfront contract will fund $17.7m for a base period of two years.

The contract if extended will support Phase 1, Phase 2, and the majority of the Phase 2/3 studies on a pediatric oral suspension, oral capsules and the intravenous formulation for CABP.

Non-human primate pilot studies of activity against biothreat pathogens, anthrax and tularemia, will also be funded under the contract.