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Cempra Announces the Completion of Phase 1 Studies for CEM-101, a Next-Generation Macrolide

Thursday, March 11, 2010 General News J E 4
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CHAPEL HILL, N.C., March 10 Cempra Pharmaceuticals today announced the successful completion of Phase 1 clinical trials of its oral formulation of CEM-101, which showed good tolerability in those studies. The company also announced plans to submit an IND to the FDA to begin a Phase 1 study with the company's intravenous formulation of CEM-101 in mid-2010.

CEM-101 is a next-generation macrolide with potent activity against pneumococci, including macrolide- and quinolone-resistant strains. Bacterial pneumonia caused by multi-drug resistant pneumococci can result in clinical treatment failure and subsequent increases in healthcare costs.

A Phase 2 trial with the oral formulation of CEM-101 is expected to begin in the second quarter of 2010 in patients with moderate to moderately severe community-acquired bacterial pneumonia (CABP). Full details of the Phase 1 studies will be presented at the upcoming European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) on April 10 to 13 in Vienna, Austria.

"Results from the Phase 1 studies suggest that CEM-101 is safe and well-tolerated and has a pharmacokinetic profile that will allow for once-daily oral dosing," said J. Carl Craft, M.D., head of medical affairs, Cempra Pharmaceuticals, and a member of Cempra's Scientific Advisory Board. "CEM-101 has enormous potential because of its broad spectrum activity, including activity against resistant strains, its capacity to be administered both orally and intravenously and its unique pattern of ribosomal binding, which may limit the development of drug-resistant strains. We expect to initiate Phase 2 studies in patients with moderate to moderately severe community-acquired bacterial pneumonia in the coming months."

Prabhavathi Fernandes, Ph.D., president and CEO of Cempra noted, "Bacterial pneumonia is a serious infection, particularly in the elderly population. Macrolides have been a mainstay of treatment for this and other indications but drug resistance has increased to more than 25% of clinical isolates. Doctors are looking for new and convenient alternatives and CEM-101 could be an important option. We look forward to advancing CEM-101 further into clinical development."

CEM-101 is expected to be the first macrolide to have an intravenous formulation available in the U.S. since intravenous azithromycin was approved in 1997, a significant development that carves a path for studies in moderate to severe community-acquired bacterial pneumonia (CABP).

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:

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 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.

-- Potent activity, in vitro and in vivo, against all important respiratory pathogens, 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 against gonococci. CEM-101 is generally 8 to 16 times more potent than azithromycin and is active against organisms that have become resistant to azithromycin. -- Good tolerability to date 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.

SOURCE Cempra Pharmaceuticals
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