Presentations of Cempra Pharmaceutical's CEM-102 (fusidic acid) at the Infectious Diseases Society of America Annual Meeting Highlight Properties That Make It an Excellent Anti-MRSA Candidate
Presentations Highlight: - Potency against Contemporary S. aureus strains, Including MRSA - Low Level Resistance Development despite Decades of Use Outside the U.S. - PK-PD Underlying Novel Oral Loading Dose Regimen to minimize future resistance development
CHAPEL HILL, N.C., Oct. 29 /PRNewswire/ -- Cempra
Pharmaceuticals today announced data presentations of its lead
antibiotic candidate, CEM-102 (fusidic acid), at the Infectious
Diseases Society of America, 47th Annual Meeting, Oct. 29 to Nov.
1, 2009, in Philadelphia.
Fusidic acid is a compound with an established record of
treating staphylococcal infections, including methicillin-resistant
S. aureus (MRSA), outside the U.S., a unique mechanism of action
and low levels of bacterial resistance. CEM-102, a new oral
formulation of fusidic acid and with a PK-PD-based dosing regimen,
is being investigated for the treatment of acute bacterial skin
structure infections in a Phase 2/3 clinical trial vs. linezolid.
This adaptive-design trial is expected to transition into a Phase 3
pivotal trial in the first quarter of 2010.
Three posters to be presented at IDSA on October 30 (12:30 to 2
p.m. EDT) confirm CEM-102's potency against contemporary isolates
of S. aureus, including MRSA, from the U.S. and Canada, with MIC90s
in the 0.25 micrograms/ml range (Posters 202, 203, 261). Isolates
resistant to other antibiotics were susceptible to CEM-102,
indicating little cross resistance to CEM-102. Importantly,
resistance to CEM-102 increased only slightly and remained low
(less than 10% of isolates), in Canadian strains isolated between
2001 and 2008 despite fusidic acid being available in Canada since
1987 (Poster 202). Mutational frequency of two strains of MRSA
following a single exposure to CEM-102 was shown to be low
providing further evidence of the low likelihood for the
development of bacterial resistance (Poster 203). The robustness of
the results from these studies was confirmed by an analysis of
bacterial susceptibility to CEM-102 using three different
susceptibility testing methods (Poster 261). The prior studies
employed broth microdilution. In this study, broth microdilution,
disk diffusion and Etest methods showed highly correlated
susceptibility results across multiple S. aureus strains.
An oral presentation, scheduled at 3:30 p.m. EDT, October 31,
presents evidence, through a pharmacokinetic-pharmacodynamic model
based on drug clearance data from 69 healthy subjects, that a
loading dose of CEM-102 on the first day of treatment can generate
significantly better antibacterial effects compared to regimens
without a loading dose. The analysis showed that a loading dose of
at least 1,200 mg twice-daily on the first treatment day followed
by 600 mg twice-daily on subsequent days optimized the
antibacterial effect of CEM-102. This provides the rationale for
the unique loading dose regimen employed in the ongoing Phase 2/3
clinical trial to minimize bacterial resistance and optimize
efficacy.
"Antibiotic-resistant S. aureus strains are an increasing
therapeutic problem both in the community as well as in the
hospital setting," said Prabhavathi Fernandes, Ph.D., chief
executive officer of Cempra Pharmaceuticals. "New treatment
alternatives are in great need, particularly agents that are safe,
administered orally, and can prevent patients from being admitted
to the hospital. The potent anti-staph activity of CEM-102, its
long safety record and low incidence of resistance make it a highly
promising anti-MRSA drug candidate."
About Cempra Pharmaceuticals
Founded in 2006, Cempra Pharmaceuticals is a privately-held,
clinical-stage biotechnology 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 viable
products through consideration of pricing and reimbursement issues
throughout its products' lifecycles. The company is also utilizing
its proprietary chemistry technology to develop macrolides without
antibacterial activity for non-antibiotic uses in motilin receptor
activity, anti-inflammatory activity and GnRH receptor antagonism.
Additional information about Cempra can be found at
www.cempra.com.
Source: Cempra Pharmaceuticals
CONTACT: Robert E. Flamm, Ph.D., +1-212-845-4226,
Robert.flamm@russopartnersllc.com;
or Tony Russo, Ph.D., +1-212-845-4251,
Tony.russo@russopartnersllc.com,
both of Russo Partners, LLC
Web Site: http://www.cempra.com/
Posted: October 2009
