Phase III SOLITAIRE IV trial of oral solithromycin has success in treatment of community-acquired bacterial pneumonia.-Cempra

Cempra, Inc. , a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, announced the publication of its pivotal Phase III study, SOLITAIRE-IV, comparing the efficacy and safety of intravenous-to-oral solithromycin to intravenous-to-oral moxifloxacin for the treatment of community-acquired bacterial pneumonia (CABP) in Clinical Infectious Diseases. As previously reported, the SOLITAIRE-IV study demonstrated that solithromycin was non-inferior to moxifloxacin, a potent respiratory fluoroquinolone, for treatment of CABP, meeting its primary endpoint that was aligned with FDA guidance.

Cempra�s other pivotal Phase III study with solithromycin, SOLITAIRE-ORAL, which evaluated the efficacy and safety of oral solithromycin versus oral moxifloxacin for the treatment of CABP, also met its primary non-inferiority endpoint and was published in Lancet Infectious Diseases in February 2016.

Comment:"The SOLITAIRE-IV study highlights the potential for physicians to transition CABP patients from IV to oral solithromycin, without needing to add or change drug classes. This type of approach could have significant clinical and public health benefits,� said Thomas M. File, M.D., from Northeast Ohio Medical University and lead author of the study.

Comment: In May 2016 Cempra completed it rolling submission to the FDA for the treatment of CAPB. In June 2016 the drug application was filed with EMA.

See- Thomas M. File, Jr, Barbara Rewerska, Violeta Vucini?-Mihailovi?,et. al. for the SOLITAIRE-IV Pneumonia Team- "SOLITAIRE-IV: A Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of Intravenous-to-Oral Solithromycin to Intravenous-to-Oral Moxifloxacin for Treatment of Community-Acquired Bacterial Pneumonia ."- Clin Infect Dis. first published online July 22, 2016 doi:10.1093/cid/ciw490 .