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Cempra’s Pivotal Phase 3 SOLITAIRE-IV Study of IV to Oral Solithromycin Published in Clinical Infectious Diseases

— Both pivotal Phase 3 studies now published in leading infectious disease journals —

— FDA and EMA currently reviewing marketing applications for solithromycin for CABP in U.S. and EU —

CHAPEL HILL, N.C., Aug. 25, 2016 (GLOBE NEWSWIRE) -- Cempra, Inc. (CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced the publication of its pivotal Phase 3 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 3 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.

“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.

“If approved, solithromycin may help address the urgent problem of antibiotic resistance and provide physicians with a new, potent macrolide monotherapy option that currently does not exist when treating patients with CABP,” File added.

According to the U.S. Centers for Disease Control and Prevention (CDC), CABP is the leading cause of death due to infectious disease in the United States, killing more than 53,000 people annually. Streptococcus pneumoniae (S. pneumoniae) is the leading cause of bacterial pneumonia in the U.S. and drug-resistant S. pneumoniae is responsible for 1.2 million infections a year, according to the CDC.

“Both of Cempra’s Phase 3 pivotal trials with solithromycin met their primary endpoint and we are pleased that both studies have now been published by two of the leading infectious disease journals in the world,” said Prabhavathi Fernandes, Ph.D., president and chief executive officer...


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