CHAPEL HILL, N.C., Jan. 12, 2011 /PRNewswire/ -- Cempra Pharmaceuticals presented the broad spectrum and potent activity profile of solithromycin (CEM-101), the first fluoroketolide antibiotic, at the 5th Annual PHEMCE stakeholders workshop and Biomedical Advanced Research and Development Authority (BARDA) industry day on January 10 to 12 in Washington D.C.
Solithromycin is a clinical-stage fluoroketolide antibiotic with potent and broad-spectrum activity against gram-positive and gram-negative pathogens, including multidrug-resistant strains, non-bacterial pathogens such as Plasmodium falciparum and a variety of bio-defense pathogens including Bacillus anthracis, Yersinia pestis, Burkholderia mallei and Francisella tularensis. Phase 1 clinical studies with the oral formulation have shown excellent safety and tolerability and a pharmacokinetic profile that will enable once-daily dosing. The oral formulation is undergoing a Phase 2 clinical trial in patients with community-acquired bacterial pneumonia (CABP). An intravenous (IV) formulation of solithromycin is undergoing a safety and tolerability evaluation in a Phase 1 single and multiple dose escalation trial in healthy volunteers. An oral pediatric suspension is also under development.
The presentation, delivered on January 12 by Jennifer Schranz, M.D., vice president of clinical affairs at Cempra Pharmaceuticals, described the potential utility of solithromycin as a bio-defense agent due to its broad antimicrobial spectrum, safety and tolerability, once-daily dosing, high tissue penetration, intracellular accumulation, and compound stability. Data from mouse models were presented on the activity of once-daily solithromycin compared to an optimal dosing regimen of ciprofloxacin against B. anthracis and gentamicin against F. tularensis. Solithromycin demonstrated activity comparable to c
|SOURCE Cempra Pharmaceuticals|
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