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

number of attributes that may provide clinically important advantages over several comparator products:

  • Eight to 16 times more potent than azithromycin and is active against organisms that have become resistant to azithromycin
  • Potent in vitro activity against all important respiratory pathogens, including pneumococci, beta-hemolytic streptococci, staphylococci, Hemophilus, Legionella, Mycoplasma, Moraxella and Chlamydophila
  • Potent in vitro activity against other medically significant pathogens, including CA-MRSA, M. avium, malaria, enterococci and gonococci
  • Good tolerability to date as demonstrated in Phase 1 trials of the oral formulation
  • Low resistance frequency in vitro
  • No inhibition of the acetylcholine nicotinic receptor, unlike telithromycin; such inhibition is believed responsible for certain adverse effects observed with telithromycin (Ketek®).
  • Excellent tissue distribution and intracellular tissue concentrations, including lung epithelial lining fluid and alveolar macrophages
  • Oral and IV formulations concurrently in development
  • Once-daily dosing

Potential for indications beyond CABP, including urethritis and other urogenital infections, bioterrorism targets, malaria, M. avium infections and tuberculosis


TAKSTA, (sodium fusidate) is a novel class of antibiotic with an established history of safety and efficacy outside the United States. TAKSTA is being developed as an NCE in the U.S. for ABSSSI. Clinical trials with TAKSTA employ a proprietary front-loading oral regimen designed to increase potency, increase coverage and minimize resistance development. Cempra believes that TAKSTA will be an important addition to anti-MRSA therapies based on the following:

  • Sodium fusidate is orally active against gr

SOURCE Cempra Pharmaceuticals
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