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Cempra Announces Comparable Efficacy of Oral Solithromycin (CEM-101) Compared with Levofloxacin in Phase II Clinical Trial in Patients with Community-Acquired Bacterial Pneumonia (CABP)
Date:9/15/2011

CHAPEL HILL, N.C., Sept. 15, 2011 /PRNewswire/ -- Cempra Pharmaceuticals today announced results from its Phase II clinical trial investigating the efficacy, safety and tolerability of oral administration of our fourth generation macrolide, solithromycin (CEM-101), a fluoroketolide antibiotic, in comparison with oral levofloxacin for the treatment of community-acquired bacterial pneumonia (CABP).  In the Phase II trial, CEM-101 demonstrated efficacy comparable to levofloxacin and a favorable safety and tolerability profile, with a lower incidence of treatment emergent adverse events than levofloxacin.  

"Macrolides have been an important therapeutic option for physicians to use for the treatment of bacterial pneumonia and other infections, but antimicrobial resistance has been increasing among the major pathogens which cause these infections," said Professor Robert Moellering, M.D., Shields Warren-Mallinckrodt Professor of Medical Research at Harvard Medical School.  "A safe macrolide as potent as CEM-101 has the potential of being a very useful agent."

David Oldach, M.D., senior vice president of clinical research of Cempra added, "Results from this trial indicate that CEM-101 is a product candidate with efficacy comparable to levofloxacin, the current standard of care for the treatment of CABP and with a favorable safety profile.  We believe these data validate the dosing strategy of CEM-101 employed in this trial and strongly support progression into Phase III trials. We look forward to presenting the full data set at an upcoming scientific conference."

Study Design

The trial was a randomized double-blind, multi-center study to evaluate the efficacy and safety of oral CEM-101 compared to oral levofloxacin in the treatment of patients with CABP.  One hundred thirty two patients were randomized to receive either CEM-101 (800 mg on Day 1 followed by 400 mg on Days 2 to 5) or levofloxacin (750 mg on Days
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