Cempra Pharmaceuticals Will Present New Data on CEM-101 and TAKSTA (CEM-102) at the 20th European Congress of Clinical Microbiology and Infectious Disease
CHAPEL HILL, N.C., April 8 /PRNewswire/ -- Cempra
Pharmaceuticals today announced its schedule of poster
presentations at the 20th European Congress of Clinical
Microbiology and Infectious Disease (ECCMID) in Vienna, Austria, on
April 10-13, 2010.
One poster will present Phase 1 multi-dose clinical results for
CEM-101, a next-generation oral and intravenous macrolide. Four
additional presentations on CEM-101 will present results on the
compound's in vitro activity against a variety of bacterial
pathogens, including drug-resistant strains. A sixth poster will
present in vitro activity of TAKSTA (CEM-102) against European gram
positive isolates, including staphylococci, streptococci and
enterococci. TAKSTA (sodium fusidate) is a highly active antibiotic
against methicillin-resistant Staphylococcus aureus (MRSA). It is
in development in the U.S. for acute bacterial skin structure
infections (aBSSI) employing a proprietary front-loading oral
dosing regimen. All six posters will be presented during the poster
session scheduled for 12:30 to 1:30 p.m. CET on Sunday, April
11.
Cempra Pharmaceuticals ECCMID 2010 Schedule At-A-Glance
Sunday, April 11, 2010
-- Poster presentation: "CEM-101, a novel fluoroketolide, tested against
European clinical isolates from 2009 (first-year surveillance
results)"
Time: On display 12:30 to 13:30 p.m. CET, Poster # 901
R. Jones, D. Farrell, H. Sader, M. Stilwell, M. Castaheira (JMI
Laboratories, North Liberty, IA, USA)
-- Poster Presentation: "Multiple dose pharmacokinetics and safety of
CEM-101, a new fluoroketolide, in healthy subjects"
Time: On display 12:30 to 13:30 p.m. CET, Poster # 902
J.G. Still, K. Clark, T. Degenhardt, D. Scott, P. Fernandes
(Cempra Pharmaceuticals, Chapel Hill, USA)
-- Poster Presentation: "CEM-101, a novel ketolide; in vitro activity
against Legionella pneumophila"
Time: On display 12:30 to 13:30 p.m. CET, Poster # 903
J. Dubois(1), P. Fernandes(2) ((1)M360, Sherbrooke, Canada,
(2)Cempra Pharmaceuticals Inc., Chapel Hill, USA)
-- Poster Presentation: "CEM-101, a novel ketolide, in vitro activity
against resistant strains of Streptococcus pnuemoniae and Haemophilus
influenza"
Time: On display 12:30 to 13:30 p.m. CET, Poster # 904
J. Dubois(1), P. Fernandes(2) ((1)M360, Sherbrooke, Canada,
(2)Cempra Pharmaceuticals Inc., Chapel Hill, USA)
-- Poster Presentation: "Expanded studies of CEM-101, a novel
fluoroketolide, tested against invasive isolates of N. meningitidis,
including flouroquinolone-non-susceptible resistant strains"
Time: On display 12:30 to 13:30 p.m. CET, Poster # 905
R. Jones, D. Biedenbach, L. Woosley, G. Gerken, M. Castaheira
(JMI Laboratories, North Liberty, IA, USA)
-- Poster Presentation: "CEM-102 (fusidic acid) in vitro activity and
evaluation of molecular resistance mechanisms among European
Gram-positive isolates, 2008-2009"
Time: On display 12:30 to 13:30 p.m. CET, Poster # 906
M. Castanheira, D. Farrell, M. Janechek, R. Jones
(JMI Laboratories, North Liberty, IA, USA)
About CEM-101
CEM-101 is a next generation macrolide with a number of
attributes that may provide clinically important advantages over
several comparator products:
-- Potent activity, in vitro and in vivo, against all important pathogens
that cause community-acquired bacterial pneumonia, including
pneumococci, as well as potent activity against a broad spectrum of
other serious pathogens including CA-MRSA, M. avium, malaria, atypical
bacteria such as Legionella, Mycoplasma, Chlamydophila, and Neisseria
-- CEM-101 is generally 8 to 16 times more potent than azithromycin and
is active against organisms that have become resistant to azithromycin
-- Novel structure with additional binding sites on the bacterial
ribosome that confers activity against erm- and mef-resistant strains
-- Good tolerability and oral bioavailability in phase 1 trials
-- Low resistance frequency in vitro
-- Excellent tissue distribution and intracellular tissue concentrations
-- Oral and IV formulations
-- Once-daily dosing
-- Potential for indications beyond CABP, including urethritis and other
urogenital infections, bioterrorism targets, malaria, M. avium
infections and tuberculosis
The annual incidence for pneumonia in the United States is over
5 million patients each year. There is a growing need for new drugs
to address the issues of drug resistance, tolerability, and
administration associated with currently available treatments.
Cempra has licensed exclusive worldwide rights from Optimer
Pharmaceuticals, Inc., except in the Association of Southeast Asian
Nations (ASEAN) countries, to discover, develop and commercialize
macrolides from a library of more than 500 compounds from Optimer's
OPopS drug discovery platform.
About TAKSTA(TM)
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 aBSSI.
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 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 capable of 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 Robert.flamm@russopartnersllc.com Tony Russo, Ph.D. Russo Partners, LLC (212) 845-4251 Tony.russo@russopartnersllc.com
Source: Cempra Pharmaceuticals
CONTACT: Robert E. Flamm, Ph.D., Russo Partners, LLC,
+1-212-845-4226,
Robert.flamm@russopartnersllc.com
or Tony Russo, Ph.D., Russo Partners, LLC,
+1-212-845-4251, Tony.russo@russopartnersllc.com
Web Site: http://www.cempra.com/
Posted: April 2010
