Grant Awarded to Study Novel Therapies for Muco-Obstructive Diseases Includes Studies on Cempra's Solithromycin (CEM-101) in a Cystic Fibrosis Anti-inflammatory Model

CHAPEL HILL, N.C., Feb. 12, 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 infectious diseases, today announced that the National Institute of Allergy and Infectious Diseases (NIAID) awarded a grant to Richard C. Boucher, M.D., Kenan Professor of Medicine and director of the Cystic Fibrosis and Pulmonary Research and Treatment Center at the University of North Carolina School of Medicine, to investigate the anti-inflammatory activity of solithromycin and its effect on mucin secretion in models for cystic fibrosis (CF).

Dr. Boucher's laboratory has studied the role of mucin secretion as well as sodium transport by respiratory epithelium.  His laboratory has also investigated the anti-inflammatory activity of and inhibition of mucin production by azithromycin, a first-generation macrolide antibiotic.  Solithromycin has demonstrated greater potency than azithromycin and other antibiotics against respiratory pathogens as well as stronger anti-inflammatory properties in vitro and in animal models. Dr. Boucher's grant, entitled "Novel Therapies for Muco-Obstructive Lung Diseases," will include tests of solithromycin for its effect on mucus production and for its anti-inflammatory effects in models for CF.

"Treatment of cystic fibrosis patients is complicated by the secretion of excessive mucin, which can trap bacteria, as well as promote airway inflammation, said Dr. Boucher.  "Our research is directed toward identifying compounds that can inhibit mucin formation, reduce inflammation and restore normal airways physiology.  Macrolides, such as azithromycin, have been used to manage these processes in CF patients in the past.  Solithromycin is one of the promising new agents in development, because of its potent anti-inflammatory and anti-mucin activity, that could become an important option for physicians managing CF patients."

Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra said, "Solithromycin is emerging as a truly differentiated antibiotic that may become an important option for physicians to treat serious infections such as community-acquired bacterial pneumonia (CABP) or gonococcal infections.  Solithromycin has demonstrated a broad activity spectrum, including against macrolide-resistant strains, in in vitro and in vivo models.  In a Phase 2 trial of patients with gonorrhea, all patients were cured with a single dose of solithromycin.  We have recently initiated a Phase 3 trial of oral solithromycin in CABP patients, which could result in the only macrolide being available as oral monotherapy to treat the disease.  An intravenous (IV) formulation is also in development and we plan to start an IV-to-oral trial in CABP in the second half of 2013.  The two dosing options would enable patients to step down from IV to oral therapy and presumably leave the hospital sooner while staying on the same antibiotic.  Dr. Boucher's research highlights another property of the compound, its anti-inflammatory and anti-mucin production activity.  We look forward to seeing the results of his work."

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 CEM-102 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 of studies of our product candidates conducted by others; the results, timing, costs and regulatory review 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.

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