June 2, 2017

Eight Presentations at ASM Microbe Include Late Breaker From Cempra's Phase 3 Fusidic Acid Study and Solithromycin Data on Gonorrhea and Otitis Media

CHAPEL HILL, N.C., June 02, 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 that researchers will present data from eight studies of fusidic acid and solithromycin at the American Society for Microbiology (ASM) 2017 meeting in New Orleans, LA.

"We are pleased that ASM has recognized data informing important potential uses of solithromycin and fusidic acid with two late breakers and eight overall presentations at the conference," said David Oldach, M.D., chief medical officer of Cempra.

Cempra's presentations at ASM Microbe consist of:

  • Comparison of the Efficacy of Solithromycin (SOLI) and Moxifloxacin (MOXI) in Patients with Community-Acquired Bacterial Pneumonia (CABP) Due to Haemophilus Influenzae
    (Friday, June 2, 12:45p-2:45p CT, Poster Session 035, Exhibit Hall D, Poster Number: 27)
  • Results of a Phase 3 Trial Comparing Oral Sodium Fusidate (Fusidic Acid) versus Oral Linezolid for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
    (Saturday, June 3, 12:15p-2:15p CT, Late Breaker Session 181a, Exhibit Hall D, Poster Number: LB21)
  • Phospholipidosis and its Reversal Induced by Solithromycin (SOL) and its Main Animal Metabolites (N-Acetyl-Solithromycin [NAS] and Des-Aminophenyltriazol-Hydroxy-Solithromycin [CEM-214]): Studies with Cultured Rat Fibroblasts
    (Sunday, June 4, 12:15p-2:15p CT, Poster Session 341, Exhibit Hall D, Poster Number: 196)
  • Results of the SOLITAIRE-U Phase 3 Trial Comparing Single Dose Oral Solithromycin versus Single Dose Intramuscular Ceftriaxone plus Single Dose Oral Azithromycin for Treatment of Uncomplicated Urogenital Gonorrhea
    (Sunday, June 4, 12:15p-2:15p CT, Late Breaker Session 334a, Exhibit Hall D, Poster Number: LB35)

In addition, Toyama, Cempra's partner for solithromycin in Japan, and JMI Laboratories, an independent laboratory conducting work supported by Cempra, will present the following abstracts:

  • Antibacterial Activity of Solithromycin (CEM-101/T-4288) and Comparators against Clinical Isolates of Streptococcus pneumoniae, Streptococcus pyogenes, and Haemophilus influenza Isolated in Japan
    (Friday, June 2, 12:45p-2:45p CT, Poster Session 039, Exhibit Hall D, Poster Number: 127)
  • Activity of Fusidic Acid against Recent Clinical Isolates of Staphylococci Collected from United States Hospitals in 2016 as Part of the SENTRY Antimicrobial Surveillance Program 
    (Saturday, June 3, 12:15p-2:15p CT, Poster Session 185, Exhibit Hall D, Poster Number: 56)
  • Pharmacokinetic-Pharmacodynamic Target Attainment Analyses to Evaluate Clinical Effect of Solithromycin (CEM-101/T-4288) for Acute Otitis Media
    (Sunday, June 4, 12:15p-2:15p CT, Poster Session 341, Exhibit Hall D, Poster Number: 195)
  • Activity of Solithromycin and Comparators against Respiratory Tract Pathogens Collected in the   2016 Global SENTRY Surveillance Program
    (Sunday, June 4, 12:15p-2:15p CT, Poster Session 335, Exhibit Hall D, Poster Number: 7)

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. (Toyama), 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' preclinical 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

jbluth@cempra.com

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Source: Cempra, Inc.

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