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Cempra Pharmaceuticals Profiles the Broad Spectrum and Potent Activity Profile of Solithromycin (CEM-101) at the 5th Annual PHEMCE Stakeholders Workshop and BARDA Industry Day
Date:1/12/2011

iprofloxacin against B. anthracis, despite a less than optimal dose.  Solithromycin also delayed mortality in mice for days after dosing against F. tularensis.  Future studies will evaluate optimal doses of solithromycin based on PK/PD modeling and the current therapeutic regimen being tested in Phase 2.  

"Solithromycin is emerging as a very promising broad spectrum, well-tolerated antibiotic," said Prabhavathi Fernandes, Ph.D., Chief Executive Officer of Cempra Pharmaceuticals.  "Pre-clinical and clinical data collected to date show it to have a broad activity spectrum and to be well tolerated in healthy volunteers.  Its flexibility of administration including once-daily oral, oral suspension and intravenous, its high tissue penetration, especially in blood and lung including lung macrophages, and its ability to target intracellular pathogens, demonstrate its significant potential for both civilian and bio-defense applications.  Building a safety and efficacy database for civilian bacterial pneumonia coupled with meeting the animal rule, which is a unique regulatory mechanism to gain FDA approval based on animal data when well-controlled efficacy studies in humans is not ethical or feasible, could be a path forward for approval for bio-defense indications."

About solithromycin (CEM-101)Solithromycin is the first fluoroketolide with a number of attributes that may provide clinically important advantages over several comparator products:

  • 8 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, enteroc
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