Pneumonia (Pediatric)

April 10, 2017

Paratek Pharmaceuticals reported results of a phase III trial comparing omadacycline to moxifloxacin in the treatment of patients with community-acquired bacterial pneumonia (CABP). The OPTIC study was a double-blind, active-controlled, global, multicenter study that enrolled 774 adult subjects with moderate to moderately severe CABP and included approximately 14% PORT Class II, 57% PORT Class III and 28% PORT Class IV. Patients initially received IV administration of either 100mg of omadacycline or 400mg of moxifloxacin. Study investigators were permitted to switch patients to oral dosing of their assigned drug (300mg once daily omadacycline or 400mg once daily moxifloxacin) for a total of seven to 14 days based on assessment of clinical stability. In the study, 774 patients were randomized. Omadacycline met the FDA-specified primary endpoint of statistical non-inferiority (NI) in the intent-to-treat (ITT) population (10% NI margin, 95% confidence interval) compared to moxifloxacin at the early clinical response (ECR) 72-120 hours after initiation of therapy. The ECR rates for the omadacycline and moxifloxacin treatment arms were 81.1 % and 82.7%, respectively. Additionally, the FDA-specified secondary endpoints evaluated omadacycline at the post treatment evaluation (PTE) visit five to 10 days after the completion of therapy in both the ITT population (87.6% for omadacycline vs. 85.1% for moxifloxacin) and in the clinically evaluable (CE) population (92.9% for omadacycline vs. 90.4% for moxifloxacin) as determined by investigators. The secondary endpoints also achieved statistical non-inferiority. This study will be used to support marketing applications to the FDA and the EMA.