Cempra Pharmaceuticals to Present Data on Solithromycin (CEM-101) and TAKSTA™ (CEM-102) at the 21st European Congress of Clinical Microbiology and Infectious Disease (ECCMID)/27th International Congress of Chemotherapy (ICC)

CHAPEL HILL, N.C., May 3, 2011 /PRNewswire/ -- Cempra Pharmaceuticals, a developer of differentiated antibiotics, today announced its schedule of presentations at the 21st European Congress of Clinical Microbiology and Infectious Disease (ECCMID)/27th International Congress of Chemotherapy (ICC) in Milan, Italy, May 7-10, 2011.

In one oral presentation and four posters, Cempra's collaborators will present new data on both of Cempra's clinical-stage antibiotic candidates: solithromycin, a fluoroketolide in development for community-acquired bacterial pneumonia with both oral and intravenous dosing forms, and TAKSTA™, a proprietary oral dosing regimen of fusidic acid in development in the U.S. for acute skin and skin structure infections, including methicillin-resistant Staphylococcus aureus (MRSA).  

Cempra Pharmaceuticals ECCMID 2011 Schedule At-A-Glance

Saturday, May 7, 2011

• Poster Session I: Antimicrobial pharmacodynamics (Poster topic 16)

Title: "Intracellular activity of fusidic acid against clinical isolates of Staphylococcus aureus of increasing MIC"

Time: On display 15:30 to 16:30 p.m. CET, Poster # 780

S. Lemaire, D. Pierard, F. Van Bambeke, P. Tulkens (Brussels, BE)

• Late Afternoon Oral Session: New antimicrobial drugs in the pipeline 

Title: "A phase 1 trial to evaluate the safety and pharmacokinetics of single doses of intravenous solithromycin (CEM-101) in healthy adult subjects"

Time: 17:54 to 18:06 p.m. CET, Oral # 95

Location: Lecture Hall Amber 2

J. Schranz, K. Clark, A. Marion, G. Ghibellini, P. Fernandes (Chapel Hill, Omaha, Research Triangle Park, US)

Sunday, May 8, 2011

• Poster Session II: AMR in Gram-positives (Poster topic 24)

Title: "Fusidic acid activity and coverage of Gram-positive pathogens associated with acute bacterial skin and skin structure infections in the USA (2008-2010)"

Time: On display 12:30 to 13:30 p.m. CET, Poster # 944

R. Jones, D. Farrell, H. Sader, M. Castanheira (North Liberty, U.S.)

• Poster Session III: New antimicrobials in vitro activity (Poster topic 38)

Title: "Antimicrobial activity of solithromycin (CEM-101), a novel fluoroketolide, tested against isolates collected in Europe during 2010 surveillance"

Time: On display 13:30 to 14:30 p.m. CET, Poster # 1136

D. Biedenbach, H. Sader, R. Jones, D. Farrell (North Liberty, U.S.)

Monday, May 9, 2011

• Poster Session IV: Miscellaneous (Poster topic 61)

Title: "Ribosomal mutations associated with ketolide resistance in Haemophilus influenzae found in the SENTRY Antimicrobial Surveillance Program"

Time: On display 12:30 to 13:30 p.m. CET, Poster # 1452

D. Farrell, L. Deshpande, R. Mendes, R. Jones (North Liberty, U.S.)

About solithromycin (CEM-101)

Solithromycin is the first fluoroketolide with a number of attributes that may provide clinically important advantages over several comparator products:

• Eight to 16 times more potent than azithromycin and is active against organisms that have become resistant to azithromycin
• Potent in vitro activity against all important respiratory pathogens, including pneumococci, beta-hemolytic streptococci, staphylococci, Hemophilus, Legionella, Mycoplasma, Moraxella and Chlamydophila
• Potent in vitro activity against other medically significant pathogens, including CA-MRSA, M. avium, malaria, enterococci and gonococci
• Good tolerability to date as demonstrated in Phase 1 trials of the oral formulation
• Low resistance frequency in vitro
• No inhibition of the 7 acetylcholine nicotinic receptor, unlike telithromycin; such inhibition is believed responsible for certain adverse effects observed with telithromycin (Ketek®).
• Excellent tissue distribution and intracellular tissue concentrations, including lung epithelial lining fluid and alveolar macrophages
• Oral and IV formulations concurrently in development
• Once-daily dosing
• Potential for indications beyond CABP, including urethritis and other urogenital infections, bioterrorism targets, malaria, M. avium infections and tuberculosis

About TAKSTA™

TAKSTA (sodium fusidate) is a novel class of antibiotic with an established history of safety and efficacy outside the United States. TAKSTA is being developed as an NCE in the U.S. for aBSSSI. Clinical trials with TAKSTA employ a proprietary, front-loading, oral regimen designed to increase potency, increase coverage and minimize resistance development. Cempra believes that TAKSTA will be an important addition to anti-MRSA therapies based on the following:

• Sodium fusidate is orally active against gram-positive bacteria, including all S. aureus strains such as HA-MRSA and CA-MRSA
• TAKSTA employs a novel and proprietary PK-PD-based dosing regimen of sodium fusidate that optimizes efficacy and minimizes the risk of resistance development
• Sodium fusidate is the only compound within the fusidane class, and, therefore, is unlikely to select for cross-resistance to other classes of antibiotics
• Sodium fusidate's safety has been well documented even when used for long periods of time (over one year) to treat osteomyelitis and other serious infections
• Sodium fusidate has been used safely in children, including neonates in countries where it is marketed

About 60 percent to 80 percent of the 13 million acute skin structure infections that occur in the U.S. each year are infected with MRSA. There is a growing need for an oral anti-MRSA drug that is safe, effective and is safe for long-term administration.

About Cempra Pharmaceuticals

Founded in 2006, Cempra Pharmaceuticals is a privately held, clinical-stage pharmaceutical company focused on developing antibacterials to address critical medical needs. Two lead products, both in late-stage clinical trials, address the urgent and increasing need for new treatments targeting drug-resistant bacterial infections in the hospital and in the community. Cempra is well-funded and is committed to developing commercially and medically differentiated and novel products that reduce development risk and provide a high financial return. The company is also utilizing its proprietary compound library and chemistry technology to develop novel macrolides without antibacterial activity for non-antibiotic uses such as COPD, chronic inflammatory and GI disorders. Additional information about Cempra can be found at www.cempra.com.

Media Contacts:

Robert E. Flamm, Ph.D
Russo Partners LLC
(212) 845-4226
[email protected]

Tony Russo, Ph.D.
Russo Partners LLC
(212) 845-4251
[email protected]

SOURCE Cempra Pharmaceuticals

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