Paratek Pharmaceuticals, Inc. announced that it has completed enrollment in the pivotal Phase 3 clinical study evaluating omadacycline for the treatment of Community Acquired Bacterial Pneumonia (CABP). This study, which is designed to assess the efficacy and safety of intravenous (IV) to once-daily oral omadacycline compared with moxifloxacin in subjects with CABP, enrolled its first patient in November 2015. The company expects to report top-line data from this study in the second quarter of 2017. This Phase 3, randomized, double-blind, multi-center study is designed to compare the safety and efficacy of IV to once-daily oral (PO) omadacycline therapy to moxifloxacin IV/PO for treating adults with CABP. This study planned to enroll approximately 750 adult subjects at approximately 120 centers worldwide. The study was designed to satisfy both FDA and EMA requirements. The primary efficacy endpoint for FDA evaluation as defined in the protocol is the number of subjects with clinical success at the early clinical response assessment visit 72-120 hours after the first dose of study drug. The EMA Co-Primary Endpoints are the Investigator’s Assessment of Clinical Response 5-10 days after the completion of treatment for the Intent to Treat (ITT) and Clinically Evaluable (CE) populations. Other efficacy outcome measurements include overall survival and resolution or improvement of signs and symptoms at the post treatment evaluation visit. Safety and tolerability are being assessed by treatment-emergent adverse events, vital sign measurements, electrocardiograms, and laboratory values.