Cempra to Present Data on Solithromycin's (CEM-101) Potential Against Urogenital Infections and Multidrug-Resistant Pathogens at ECCMID - Phase 2 study of patients with gonococcal infections shows 100 percent were treated successfully

- Solithromycin is active against Mycoplasma genitalium, a pathogen that is increasingly resistant to treatment with any antibiotic

- Solithromycin demonstrates superior activity to azithromycin against Legionella pneumophila, a serious pnuemonia pathogen

- Solithromycin demonstrates activity against enterococci, a pathogen with few treatment options

CHAPEL HILL, N.C., April 26, 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 will present data at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Berlin, demonstrating solithromycin's potential to treat urogenital infections and combat challenging pathogens such as enterococci and Legionella pneumophila. All of the presentations will occur on Sunday, April 28.

"Solithromycin, our fourth-generation macrolide, has the right spectrum of activity against a variety of serious gram positive pathogens as well as an emerging favorable safety profile," said Prabha Fernandes, Ph.D., chief executive officer of Cempra.  "The studies to be presented at ECCMID demonstrate the antibiotic's potential against bacterial urethritis as well as against serious pathogens such as enterococcus and Legionella for which therapeutic options are either few or decreasing due to increasing antibiotic resistance.  Solithromycin continues to differentiate itself against other treatments for community-acquired bacterial pneumonia, sexually-transmitted diseases and other serious infections."

Abstract O 274: 11:42-11:54 a.m. CEST: A phase II study to evaluate the efficacy and safety of single-dose oral solithromycin (CEM-101) for treatment of patients with uncomplicated urogenital gonorrhea

E. Hook, III, D. Oldach, B. Jamieson, K. Clark, P. Fernandes

  • Patients with suspected N. gonorrhoeae infections received a single oral 1,200 mg dose of solithromycin
  • Infections were eradicated from all 22 evaluable patients (from an enrollment of 28) including from cervical, urethral, rectal and pharyngeal infection sites
  • Solithromycin was well tolerated and was accompanied by only mild gastrointestinal effects

Abstract P 1640, 1:30-2:30 p.m. CEST: In vitro and intracellular activity of solithromycin (CEM-101) against clinical isolates of Legionella pneumophila

J. Mallegol, P. Fernandes, R. Melano, C. Guyard

  • Legionella pneumophila is an important respiratory pathogen
  • Azithromycin and fluoroquinolones are the currently-recommended treatments but resistance to both antibiotics is increasing; cephalosporins are ineffective
  • Solithromycin demonstrated higher in vitro potency against all L. pneumophila isolates than azithromycin

Abstract P 1593, 1:30-2:30 p.m. CEST: Analysis of solithromycin bactericidal activity against vancomycin-susceptible and vancomycin-resistant enterococci

J Deane, C. Opiela, D Sahm, K. Keedy, A. Sheets, P. Fernandes

  • Linezolid was the last antibiotic approved to treat enterococcal infections
  • MICs for solithromycin were relatively low compared to linezolid suggesting that a macrolide could be an option to treat these infections
  • Although neither solithromycin nor linezolid demonstrated bactericidal activity, solithromycin almost eradicated one strain, suggesting that solithromycin's spectrum of activity may differ from those of older macrolides and ketolides.

Abstract P 1638, 1:30-2:30 p.m. CEST: In vitro activity of solithromycin (CEM-101) among azithromycin resistant and susceptible Mycoplasma genitalium strains

J.S. Jensen, P. Fernandes and M. Unemo

  • Mycoplasma genitalium is a well-known and important cause of sexually transmitted infections
  • Treatment with a 1 gram single dose azithromycin induces high-level macrolide resistance in many cases where eradication fails; drug-resistant strains of M. genitalium are emerging
  • Solithromycin, a new fluoroketolide that is active against other urogenital pathogens, demonstrated antimicrobial activity, in vitro, that was superior to azithromycin and other macrolides
  • Solithromycin may be a promising alternative to current treatments for M. genitalium and its strong activity suggests that the drug could lead to less selection of macrolide-resistant strains of M. genitalium

Abstract P 1603, 1:30-2:30 p.m. CEST: Evaluation of disc diffusion testing of solithromycin using Mueller Hinton fastidious medium

J. Deane, C. Opiela, E. Matuschek, G. Kahlmeter, D. Sahm, K. Keedy, A. Sheets, P. Fernandes

  • Disk diffusion testing is used in the determination of clinical breakpoints to measure pathogen susceptibility to antibiotics
  • This study determined that solithromycin disk diffusion results obtained with the control and clinical strains were comparable with two different disk sources on agar from two different manufacturers indicating that results are likely to be very similar for the target pathogens, regardless of which agar medium (CLSI or EUCAST) is used for testing

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 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
Robert.flamm@russopartnersllc.com

Andreas Marathovouniotis
Russo Partners LLC
(212) 845-4235
Andreas.marathis@russopartnersllc.com

 

SOURCE Cempra, Inc.




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