Paratek announced positive top-line data from the global Phase 3 trial of omadacycline for the treatment of community-acquired bacterial pneumonia (CABP).
The OPTIC (Omadacycline for Pneumonia Treatment in the Community) study was a randomized, multicenter, double-blind, active-controlled, Phase 3 trial evaluating the efficacy and safety of once-daily, IV-to-oral omadacycline vs. moxifloxacin in 774 adult patients with moderate to moderately severe CABP. Patients initially received either IV formulation of omadacycline (100mg) or moxifloxacin (400mg), then switched to oral formulation for a total of 7–14 days of therapy. The FDA-specified primary endpoint was statistical non-inferiority (NI) to moxifloxacin in the intent-to-treat (ITT) population (10% NI margin, 95% confidence interval) at the early clinical response (ECR) 72–120 hours after initiation of therapy. Secondary endpoints included statistical non-inferiority at the post treatment evaluation (PTE) visit 5–10 days after the completion of therapy in both the ITT population and in the clinically evaluable (CE) population as determined by investigators.
The study met the primary and secondary endpoints, showing that omadacycline is non-inferior to moxifloxacin for the treatment of CABP. Omadacycline showed statistical non-inferiority to moxifloxacin in the ITT population at the ECR, with rates of 81.1 % and 82.7%, respectively. Statistical non-inferiority for omadacycline was also achieved at the PTE, with rates of 87.6% for omadacycline vs. 85.1% for moxifloxacin in the ITT population and 92.9% vs. 90.4%, respectively, in the CE population.
Omadacycline was found to be generally safe and well-tolerated, consistent with results from previous studies. The rates of treatment emergent adverse events (TEAEs) were 41.1% for omadacycline vs. 48.5% for moxifloxacin, with 10.2% vs.17.8%, respectively, found to be drug-related. The most common TEAEs reported were ALT increase and hypertension. The most common gastrointestinal adverse events were vomiting, nausea and diarrhea. No cases of Clostridium difficile colitis or infection were reported in the omadacycline treatment group compared to seven cases in the moxifloxacin group. Detailed results of the OPTIC study will be presented at an upcoming scientific congress.
The FDA previously granted omadacycline Qualified Infectious Disease Product and Fast Track designations for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and CABP. Paratek plans to submit the New Drug Application for omadacycline as early as the first quarter of 2018.
Omadacycline, a once-daily, oral and IV antibiotic, is the first in a new class of tetracyclines known as aminomethylcyclines, with broad-spectrum activity against Gram-positive, Gram-negative and atypical bacteria.
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