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)

Chapel Hill, NC /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 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 Discharge Survey, 2006; File, T.M. and Marrie, T., Postgrad. Med., 2010). There is a great need for new drugs that are well tolerated and that may be administered both orally and intravenously, to address the crisis of emergent drug resistance. Cempra has licensed exclusive worldwide rights from Optimer Pharmaceuticals, Inc., except in the Association of Southeast Asian Nations (ASEAN) countries, to discover, develop and commercialize macrolides from a library of more than 500 compounds from Optimer's OPopS drug discovery platform, including CEM-101.

About Cempra Pharmaceuticals
Founded in 2006, Cempra Pharmaceuticals is a privately-held, clinical-stage pharmaceutical company focused on developing antibacterials to address critical medical needs in the treatment of infectious diseases caused by bacteria. Our two lead product candidates have both completed oral Phase II clinical trials and seek to address the urgent and increasing need for new treatments targeting drug-resistant bacterial infections in the hospital and in the community. The company is also utilizing its proprietary compound library and chemistry technology to develop novel macrolides without antibacterial activity for non-antibiotic uses such as COPD, chronic inflammatory and GI disorders. Additional information about Cempra can be found at www.cempra.com.

SOURCE Cempra Pharmaceuticals