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Cempra To Present Full Data Set Of Phase 2 Clinical Trial Of CEM-101

Cempra Inc. (CEMP) said that data will be presented at the European Congress of Clinical Microbiology and Infectious Diseases or ECCMID, in London, demonstrating CEM-101's efficacy to be comparable to levofloxacin in a Phase 2 trial of patients with community-acquired bacterial infections or CABP.

The phase 2 clinical trial of the study also showcases olithromycin's favorable safety and tolerability profile compared to levofloxacin, the company added.

Solithromycin is the first fluoroketolide with a number of attributes that may provide clinically important advantages over several comparator products.

Prabhavathi Fernandes, chief executive officer of Cempra commented "This is the first time that the full data set of this Phase 2 trial has been available for review by the infectious disease community. The promising results of this clinical trial will now be the basis for the initiation of our Phase 3 program in CABP. We expect to begin the first Phase 3 trial evaluating oral solithromycin in moderate-to-moderately severe CABP patients in the second half of 2012."

The CEO stated " Additionally, we are planning Phase 3 trials for 2013 testing the efficacy of intravenous-to-oral step down administration of solithromycin in moderate-to-severe CABP."

In a separate press release, the clinical-stage pharmaceutical company noted that data will be presented at the ECCMID demonstrating that CEM-101 (solithromycin) would be active against antibiotic-resistant strains of N. gonorrhoeae.

Magnus Unemo, associate professor, National Reference Laboratory for Pathogenic Neisseria said "In vitro studies, including the presentation at ECCMID, have indicated that solithromycin can be a promising agent for treating patients with gonococcal infections. N. gonorrhoeae is becoming a serious public health problem because current antibiotic options are gradually becoming less effective in treating the disease. New options are required and solithromycin appears to be a promising candidate."

by RTT Staff Writer

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