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Cempra Pharmaceuticals Initiates Phase 2/3 Clinical Study for an Oral Antibiotic to Treat Acute Bacterial Skin Structure Infections.

Study to compare CEM-102 (Fusidic acid fusidic acid

a lipophilic steroid antibioitic, the product of Fusidium coccineum; mainly active against gram-positive bacteria.
) to Linezolid in the treatment of ABSSIs, including those caused by MRSA MRSA Methicillin-resistant Staphylococcus aureus. See MARSA.  

CHAPEL HILL, N.C. -- Cempra Pharmaceuticals today announced that enrollment is underway in an adaptive design Phase 2/3 clinical study with CEM-102 for patients suffering from acute bacterial skin structure infections (ABSSI ABSSI Association of Business Support Services International ). CEM-102 is an oral antibiotic with an established record of treating staphylococcal infections Staphylococcal Infections Definition

Staphylococcal (staph) infections are communicable conditions caused by certain bacteria and generally characterized by the formation of abscesses.
 outside the United States, including those due to methicillin-resistant Staphylococcus aureus methicillin-resistant Staphylococcus aureus Methicillin-aminoglycoside resistant Staphylococcus aureus, MRSA An organism with multiple antibiotic resistances–eg, aminoglycosides, chloramphenicol, clindamycin, erythromycin, rifampin, tetracycline,  (MRSA). It is effective against all staphylococci, including hospital-acquired MRSA (HA-MRSA) and community-acquired MRSA (CA-MRSA CA-MRSA Community Acquired Methicillin-Resistant Staphylococcus Aureus ). Cempra has the exclusive source to the antibiotic and has advanced the development of the compound in the United States, including formulation development, to minimize resistance development.

"It is well-known that MRSA and bacterial resistance against the current arsenal of antibacterials are rising at alarming rates, and new antibiotics, especially oral drugs, are needed to combat this growing problem," notes Dr. Prabhavathi Fernandes, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of Cempra Pharmaceuticals. "This compound, previously approved outside the United States to treat staphylococcal infections, has shown activity against a range of difficult-to-treat and drug-resistant infections, and Cempra is advancing CEM-102 in a proprietary dosing regimen to address the resistance issues we are seeing in both hospital and community settings today. We are essentially giving new life to an established oral drug that has a history of safe and effective use outside the U.S."

The first of two pivotal trials is an adaptive design, randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
, double-blind, multi-center study to evaluate the safety and efficacy of orally-administered CEM-102 compared to linezolid in the treatment of ABSSIs. Cempra estimates enrollment of 880 patients with a diagnosis of an ABSSI that would be expected to require 10 to 14 days of antibacterial therapy. Dr. Gordon Still, CMO CMO

See: Collateralized mortgage obligation


See collateralized mortgage obligation (CMO).
 of Cempra said, "As of today, the study is ahead of projected patient enrollment timelines and interim data are expected by year end." The study will measure treatment success rates in the clinically evaluable and intent-to-treat patient populations at the test of cure visit.

In addition to CEM-102, Cempra's lead macrolide, CEM-101, will soon enter a Phase 2 clinical trial phase 2 clinical trial Phase 2 study. See Phase study.  for moderate to moderately-severe community-acquired bacterial pneumonia. Both CEM-102 and CEM-101 will potentially address key antibacterial needs identified by the Infectious Disease Society of America. Cempra completed a $46 million Series C financing in 2009 that will fund the further development of these compounds.

About Cempra Pharmaceuticals

Founded in 2006, Cempra Pharmaceuticals is a privately-held, clinical-stage biotechnology company focused on developing two antibacterials to address critical medical needs. These 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
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Publication:Business Wire
Article Type:Clinical report
Date:Sep 9, 2009
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