Cempra Presents Post-Phase 2 Analysis of Solithromycin's Efficacy and Safety Results from Patients with Community Acquired Bacterial Pneumonia (CABP)

CHAPEL HILL, N.C., May 20, 2013 /PRNewswire/ -- Cempra, Inc. (Nasdaq: CEMP), a clinical-stage pharmaceutical company focused on developing differentiated antibiotics to meet critical medical needs in the treatment of bacterial infections, today announced that it presented data at the American Thoracic Society International Conference (ATS 2013) in Philadelphia demonstrating the antibacterial and enhanced immunomodulatory activity of solithromycin versus levofloxacin in Cempra's prior Phase 2 clinical trial in outpatients with community acquired bacterial pneumonia (CABP). Solithromycin's efficacy profile was comparable to levofloxacin's while solithromycin demonstrated favorable tolerability versus levofloxacin. Solithromycin also demonstrated an enhanced anti-inflammatory response in in vitro studies based on decreased production of inflammatory cytokines and showed re-sensitization to steroids.  The Study, Jamieson et al. (Poster Board # H55) was presented at 8:15 a.m. to 4:30 p.m. EDT, Sunday, May 19.

"Macrolides, such as azithromycin, have been shown to reduce morbidity and mortality in chronic lung diseases such as COPD and diffuse panbronchiolitis," said Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra. "The results from this analysis of our Phase 2 clinical trial of oral solithromycin in CABP patients suggest that the comparable early clinical response rates of solithromycin versus levofloxacin may be enhanced by anti-inflammatory properties. Our data provide additional support for our development of solithromycin as a differentiated drug-resistant treatment for CABP and with potential for use in COPD."

About Cempra, Inc.
Founded in 2006, Cempra, Inc. is a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases. Cempra's two lead product candidates are in advanced clinical development; solithromycin in Phase 3 for CABP and TAKSTA™ (CEM-102) in Phase 2 for prosthetic joint infections.  Both seek to address the need for new treatments targeting drug-resistant bacterial infections in the hospital and in the community. The company also intends to use its series of proprietary lead compounds from its novel macrolide library for uses such as the treatment of chronic inflammatory diseases, endocrine diseases and gastric motility disorders. Additional information about Cempra can be found at www.cempra.com.

Please Note: This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others:  the results, timing, costs and regulatory review, and other analyses, of our studies and clinical trials; our need to obtain additional funding and our ability to obtain future funding on acceptable terms; our anticipated capital expenditures and our estimates regarding our capital requirements; our ability to obtain FDA approval of our product candidates; our dependence on the success of solithromycin and Taksta; and innovation by our competitors. The reader is referred to the documents that we file from time to time with the Securities and Exchange Commission.

Investor and Media Contacts:

Robert E. Flamm, Ph.D.
Russo Partners, LLC
(212) 845-4226 
[email protected]

Andreas Marathovouniotis
Russo Partners LLC
(212) 845-4235
[email protected]

SOURCE Cempra, Inc.