Cempra Presents Data at ECCMID Highlighting Need for New CABP Therapies and Activity of Solithromycin in Key Population Groups

CHAPEL HILL, N.C., April 21, 2017 (GLOBE NEWSWIRE) — Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced the company is presenting eight abstracts highlighting solithromycin and the need for new treatments for community-acquired bacterial pneumonia (CABP) at the 27th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Vienna, Austria.

“As we continue to analyze data from our solithromycin trials, a pattern of activity across pathogens, geographies and patient types continues to emerge,” said David Oldach, M.D., chief medical officer of Cempra.

“Considering the documented risks associated with fluoroquinolone treatment, and the correlation between treatment failure and mortality, patients and physicians would benefit greatly from new safe and effective antibiotic treatment options for CABP,” Oldach added.

Cempra’s presentations at ECCMID consist of:

  • Characterization of Streptococcus Pneumoniae from the Solithromycin Global Clinical Trial Programme in Community Acquired Pneumonia 
    (Saturday, April 22, 3:30p-4:30p CET, Abstract Number: 7072)
  • Efficacy of Solithromycin versus Moxifloxacin in the Treatment of CABP by Baseline PORT Risk Class: Results from Two Large, Multi-National Studies 
    (Monday, April 24, 12:30p-1:30p CET, Abstract Number: 6890)
  • Efficacy of Solithromycin for Treatment of Community-Acquired Pneumonia by Patient Age: Pooled Analysis of Two Multinational, Double-Blind, Randomized, Controlled Studies 
    (Monday, April 24, 12:30p-1:30p CET, Abstract Number: 6970)
  • Early Clinical Response (ECR) of Solithromycin Compared with Moxifloxacin in Microbiologically Positive Subjects from Two Global Clinical Trials in Community-Acquired Bacterial Pneumonia
    (Monday, April 24, 12:30p-1:30p CET, Abstract Number: 6985)
  • Multi-National Studies Comparing Solithromycin, a New Macrolide, to Moxifloxacin in the Treatment of CABP: Response by Geographical Region 
    (Monday, April 24, 12:30p-1:30p CET, Abstract Number: 7001)
  • Evaluation of Early Clinical Response as a Primary Endpoint for CABP: Pooled Analysis of Phase 3 Studies Comparing Solithromycin, a New Macrolide, and Moxifloxacin 
    (Monday, April 24, 12:30p-1:30p CET, Abstract Number: 7024)
  • Relationship Between Antibiotic Treatment Failure and 30-Day Mortality in Adult Outpatients with Community-Acquired Pneumonia 
    (Tuesday, April 25, 2:18p-2:28p CET, Abstract Number: 1178—Oral Presentation)
  • Adverse Events Associated with Fluoroquinolone and Macrolide Therapy in Adult Outpatients Treated for Community-Acquired Pneumonia 
    (Tuesday, April 25, 2:42p-2:52p CET, Abstract Number: 3924—Oral Presentation)

About Cempra, Inc.

Cempra, Inc. is a clinical-stage pharmaceutical company focused on developing differentiated anti-infectives for acute care and community settings to meet critical medical needs in the treatment of infectious diseases. Cempra’s two lead product candidates are currently in advanced clinical development. Solithromycin has been evaluated in two phase 3 clinical trials for community-acquired bacterial pneumonia (CABP). Cempra is currently seeking approval for CABP for both intravenous and oral capsule formulations from the U.S. Food and Drug Administration. Solithromycin is licensed to strategic commercial partner Toyama Chemical Co., Ltd., a subsidiary of FUJIFILM Holdings Corporation, for certain exclusive rights in Japan. Cempra is contracted with BARDA for the development of solithromycin for pediatric use and has commenced enrollment in a global Phase 2/3 trial to evaluate the safety and efficacy of solithromycin versus standard of care antibiotics in children and adolescents from two months to 17 years of age. Solithromycin is also in development for uncomplicated urogenital urethritis caused by Neisseria gonorrhoeae or chlamydia. Fusidic acid is Cempra’s second product candidate, which has completed a phase 3 trial comparing fusidic acid to linezolid in patients with acute bacterial skin and skin structure infections (ABSSSI). Cempra also has an ongoing exploratory study of fusidic acid for chronic oral treatment of refractory infections in bones and joints. Both products seek to address the need for new treatments targeting drug-resistant bacterial infections in the hospital and in the community. Cempra is also studying solithromycin for ophthalmic conditions and has synthesized novel macrolides for non-antibiotic uses such as the treatment of chronic inflammatory diseases, endocrine diseases and gastric motility disorders. Cempra was founded in 2006 and is headquartered in Chapel Hill, N.C. For additional information about Cempra please visit 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: results of our and our strategic commercial partners’ pre-clinical studies and clinical trials are not predictive of results from subsequent clinical trials for any possible therapy; our ability to obtain FDA and foreign regulatory approval of solithromycin as a treatment for community acquired bacterial pneumonia; our dependence on the success of solithromycin and fusidic acid; our and our strategic commercial partners’ ability to obtain FDA and foreign regulatory approval of our product candidates; the costs, sources of funds, enrollment, timing, regulatory review and results of our studies and clinical trials and those of our strategic commercial partners; the unpredictability of the size of the markets for, and market acceptance of, any of our products, including solithromycin and fusidic acid; our ability to commercialize and launch, whether on our own or with a strategic partner, any product candidate that receives regulatory approval; our ability to produce and sell any approved products and the price we are able to realize for those products; innovation by our competitors; and our ability to stay abreast of and comply with new or modified laws and regulations that currently apply or become applicable to our business. The reader is referred to the documents that we file from time to time with the Securities and Exchange Commission.

CONTACT: John Bluth
Cempra, Inc.
(984) 209-4534