CHAPEL HILL, N.C., June 13, 2013 /PRNewswire/ -- Cempra, Inc. (Nasdaq: CEMP), a clinical-stage pharmaceutical company focused on developing differentiated antibiotics to meet critical medical needs in the treatment of bacterial infections, today described the steps expected for regulatory approval for solithromycin for community-acquired bacterial pneumonia (CABP). This path forward is a result of a dialogue and End-of-Phase 2 meeting with the Food and Drug Administration (FDA).
"We believe our End-of-Phase 2 meeting with the FDA has provided us with clear direction toward approval of solithromycin for CABP," said Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra. "We were pleased with the FDA input and believe we are in a position to proceed with our second Phase 3 study and the rest of the clinical program, subject to receipt of the necessary funding. We know the requirements for the CABP safety database and efficacy endpoints for NDA submission. In addition, we received preliminary feedback on the trial design for the uncomplicated gonococcal infection indication."
The Phase 3 solithromycin clinical program in CABP will be planned to consist of an oral trial and an intravenous (IV)-to-oral clinical trial. Cempra followed the CABP guidance that the FDA proposed in a November, 2011, meeting of the Anti-Infective Drugs Advisory Committee. The FDA provided comments on the Phase 3 oral CABP protocol in June, 2012, and this global study is ongoing. This study compares five days of oral solithromycin with seven days of oral moxifloxacin. FDA responses prior to and at the End-of-Phase 2 meeting addressed the second Phase 3 study, which is the planned intravenous-to-oral step-down trial.
In the IV-to-oral Phase 3 study, approximately 800 patients with Port II to
|SOURCE Cempra, Inc.|
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