Oral solithromycin: Phase I started

Cempra began an open-label, U.S. Phase I trial to evaluate oral solithromycin for up to 5 days as add-on therapy in patients ages 12-17 years with suspected or confirmed bacterial infections. Afterwards, the trial will evaluate an oral suspension formulation in younger age groups down to newborns and an IV formulation in all pediatric age groups. The trial is funded by Cempra's 2013 contract from HHS's Biomedical Advanced Research and Development Authority (BARDA) to develop solithromycin to treat infections in pediatric populations and infections caused by bioterror threat pathogens (see BioCentury, June 3, 2013).

Last year, FDA granted Qualified Infectious Disease Product (QIDP) designation for an oral formulation of solithromycin to treat community-acquired bacterial pneumonia (CABP), for which it is in Phase III testing (see BioCentury, Sept. 16, 2013). Cempra is also conducting an IV-to-oral step-down Phase III trial with solithromycin. ...