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Cempra Expands Clinical Management Team to Advance Leading Antibacterial Clinical Programs Solithromycin and TAKSTAâ„¢

Thu, 03/03/2011 - 4:37am
Bio-Medicine.Org

CHAPEL HILL, N.C., March 3, 2011 /PRNewswire/ -- Cempra Pharmaceuticals today announced the appointment of David Oldach, M.D. as vice president, clinical research as well as announcing an expansion of its clinical development team to manage the company's leading clinical programs, solithromycin and TAKSTA through advanced clinical development.  The four appointments have significant anti-infective clinical development experience.

Solithromycin is Cempra's innovative oral and intravenous next-generation fluoroketolide exhibiting high potency against respiratory pathogens, including drug-resistant strains, and broad spectrum activity against other serious pathogens.  The oral form is undergoing a global Phase 2 clinical trial in patients with community-acquired bacterial pneumonia. Intravenous solithromycin is undergoing multi-dose and dose escalation Phase 1 trials in healthy volunteers. Results from both the Phase 2 oral and the Phase 1 intravenous studies are expected in the second quarter 2011.

TAKSTA is an innovative oral dosing regimen of sodium fusidate, employing a PK-PD-based proprietary dosing regimen, under development for gram-positive infections including drug-resistant strains such as methicillin-resistant Staphylococcus aureus (MRSA).  TAKSTA has completed enrollment in a Phase 2 trial and is preparing for Phase 3 studies in the U.S. for acute bacterial skin structure infections (aBSSSI).

"Both of our lead clinical programs have made substantial progress over the last year," said Prabhavathi Fernandes, chief executive officer of Cempra.  "Solithromycin is now in development with both oral and intravenous formulations for CABP.  TAKSTA, now in preparation for Phase 3 trials in acute bacterial skin and skin structure infections, has po

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