Navigation Links
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
Date:10/28/2009

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


'/>"/>
SOURCE Cempra Pharmaceuticals
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Threshold Pharmaceuticals Announces Two Presentations on Glufosfamide at the 2007 European Cancer Conference (ECCO)
2. Threshold to Host Conference Call to Discuss Results From Clinical Presentations at European Cancer Conference (ECCO)
3. IDM Pharma Announces Upcoming Clinical Data Presentations
4. Access Pharmaceuticals Announces Two Poster Presentations Reporting Significant Preclinical Data on ProLindac(TM) at the AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference
5. Schering-Plough Highlights PEGINTRON(TM) Clinical Data Presentations at the American Association for the Study of Liver Diseases (AASLD) 2007 Annual Meeting
6. CuraGen and TopoTarget Announce Presentations on Belinostat at the Upcoming American Society of Hematology 49th Annual Meeting
7. TargeGen Announces Planned Initiation of Clinical Trial of JAK2 Inhibitor TG101348 in Myeloproliferative Disease Patients, and Presentations at ASH
8. Pharmasset Announces Clevudine and R7128 Presentations at HEP-DART
9. SuperGen to Highlight Oncology Pipeline Data in Multiple Presentations at the AACR Annual Meeting
10. Pharmacyclics Reports Multiple Presentations at AACR on Its HDAC and Selective HDAC Inhibitors
11. Schering-Plough Highlights PEGINTRON(TM) and Boceprevir Data Presentations at European Association for the Study of the Liver (EASL) Annual Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/11/2016)... , February 11, 2016 --> ... of a new research report, titled "Sports Medicine Devices Market ... 2013 - 2019". According to the report, the global sports ... CAGR from 2013 to 2019, growing from a value of ... --> --> The global sports ...
(Date:2/11/2016)... -- Jeffrey Zucker , vice president of ... at this year,s Summit for Clinical Operations Executives (SCOPE), being ... Miami, FL. Zucker will discuss how sponsors can ... SCOPE,s "Improving Site Study Activation and Performance" portion of the ... at 11:05 a.m. --> --> ...
(Date:2/11/2016)... , February 11, 2016 F ast ... answers at the ... world-leading provider of scientific, technical and medical information products and services, has ... evidence-based, peer reviewed clinical information via a mobile device. Elsevier designed the ... for Nursing. The new app is available in Android and ...
Breaking Medicine Technology:
(Date:2/12/2016)... ... February 12, 2016 , ... Basketball is a game ... part of the Peety PoppersTM series, sign language translation is featured in the top ... and wellness in Peety PoppersTM lessons has a sign language translator to teach kids ...
(Date:2/12/2016)... Phoenix, AZ (PRWEB) , ... February 12, 2016 , ... ... Health Arizona General Hospital Emergency Room –Mesa. The new facility is licensed under ... Valley. , “Dr. Bingham is an excellent leader and will ensure our new ...
(Date:2/11/2016)... ... February 11, 2016 , ... According to an ... marketed as a weight loss dietary supplement, is being recalled due to the discovery ... Physicians, because there is not a single supplement on the market proven to help ...
(Date:2/11/2016)... ... ... Registered nurses, licensed practical nurses and nursing aides who treat stroke patients ... to Heal” on Thursday, February 25 from 9:00 to 11:00 a.m. at the ... of ANSA Consultants, who will discuss clinical best practices throughout the continuum of stroke ...
(Date:2/11/2016)... ... 12, 2016 , ... The Journal of Pain Research has seen ... SJR uses data taken from the Scopus database (Elsevier B.V.) and is a measure ... by the journal over a three year period and also the importance of the ...
Breaking Medicine News(10 mins):