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Intravenous (IV) Administration of Cempra Pharmaceutical's Solithromycin (CEM-101) Demonstrates Excellent Systemic Tolerability in a Phase 1 Clinical Trial
Date:5/7/2011

rcent). Group A streptococci (S. pyogenes) were inhibited at less than 8 mg/L. These drug levels are well below the 80 microgram/mL trough level achieved by the loading dose currently in clinical trials in the U.S.

Intracellular S. aureus can be challenging to treat as antibiotics may have difficulty reaching active concentrations.  Lemaire et al. (Abst. P780) tested the activity of fusidic acid against intracellular clinical isolates of S. aureus.  Fusidic acid was active against intracellular strains even when the strains exhibited a low level of resistance (8 micrograms/mL).  With the loading dose in clinical development in the U.S. by Cempra Pharmaceuticals, intracellular fusidic acid concentrations reach 80 micrograms/mL, which is sufficient to address these strains both intracellularly and extracellularly.

Prabhavathi Fernandes, Ph.D, chief executive officer of Cempra added, "We continue to add valuable information to the profiles of our two differentiated clinical-stage antibiotics.  Solithromycin continues to demonstrate potent activity against a broad spectrum of bacterial pathogens.  With its excellent tolerability demonstrated to date and its flexible oral and IV dosing, it is evolving into a very promising antibiotic candidate with significant potential to treat common and atypical bacterial infections.  TAKSTA continues to demonstrate potent activity against U.S. gram-positive strains.  We believe its oral dosing combined with our loading dose regimen will enable the drug to be a go-to antibiotic for serious ABSSSIs when there is benefit to keeping the patient out of the hospital.  We continue moving both programs forward in clinical development."

About solithromycin (CEM-101)

Solithromycin is the first fluoroketolide with a
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SOURCE Cempra Pharmaceuticals
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