Cempra sees 'clear direction' for approval for solithromycin after FDA meeting

Cempra described the steps expected for regulatory approval for solithromycin for community-acquired bacterial pneumonia, or CABP. This path forward is a result of a dialogue and End-of-Phase 2 meeting with the Food and Drug Administration. The company said, "We believe our End-of-Phase 2 meeting with the FDA has provided us with clear direction toward approval of solithromycin for CABP. 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-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. A single Phase 3 study of solithromycin in uncomplicated gonococcal infection would likely be sufficient if the Phase 3 CABP trials are successful, the company said. The specific protocol remains under discussion. Cempra also noted that on June 12 the FDA issued a proposed rule listing pathogens that would be eligible for drug development incentives under the Generating Antibiotic Incentives Now Act. Solithromycin has demonstrated activity against all of the pathogens proposed for eligibility, Cempra said, adding that there can be no assurances that the FDA proposal, which is subject to a public comment period, will become a final rule or that, if passed, the final rule will include any or all of the pathogens.