Cempra demonstrates solithromycin's potential against urogenital infections at ECCMID

Apr 29 2013

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

SOURCE Cempra, Inc.