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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

1 to 5).  Patients were enrolled if diagnosed with PORT II-to-IV pneumonia.  The primary outcome measure was continued improvement or complete resolution of baseline signs and symptoms in the intent to treat (ITT) and the clinically evaluable (CE) populations at the Test of Cure (TOC) visit, which was completed five to 10 days after the last dose of the drug.

"Cempra's mission is to develop differentiated antibiotics that confront today's challenges of bacterial resistance to existing antibiotics," said Prabhavathi Fernandes, president and chief executive officer of Cempra.  "Completing this Phase II trial is an important milestone for the company. I congratulate our staff for their good work.  The data from this study strongly support further evaluation of orally-administered CEM-101 in the treatment of CABP in an 'all-oral therapy' Phase III trial, and as a component of IV-to-oral Phase III trials."

About CEM-101

CEM-101 is the first fluoroketolide with a number of attributes that may provide clinically important advantages over several comparator products.  Our clinical trials and pre-clinical studies have shown that CEM-101, with its unique chemical structure, has:

  • a favorable safety and tolerability profile;
  • comparable efficacy to the current standard of care;
  • potent activity against a broad range of bacteria with excellent tissue distribution and intracellular activity;
  • a lower incidence of resistance development;
  • IV, oral and suspension formulations that allow it to be used in all patient populations and settings; and
  • anti-inflammatory qualities to help patients feel better sooner during treatment.

The annual incidence for CABP in the United States is over five million with over one million hospitalized (File, T.M., Lancet, 2003; File, T.M. and Tan, J.S. JAMA, 2005; CDC, National Hospital Dis
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SOURCE Cempra Pharmaceuticals
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