Paratek Pharmaceuticals Inc. reported positive top-line results from a phase 3 study comparing its once-daily oral and IV, broad spectrum investigational antibiotic, omadacycline, to moxifloxacin in the treatment of patients with community-acquired bacterial pneumonia.
Omadacycline met FDA-specified primary endpoint by showing statistical non-inferiority in the intent-to-treat population, with early clinical response rates for the omadacycline and moxifloxacin treatment arms of 81.1 % and 82.7%, respectively.
The drug also showed statistical non-inferiority in the FDA-specified secondary endpoints, which evaluated omadacycline at the post-treatment evaluation visit 5-10 days after the completion of therapy in both the intent-to-treat population — 87.6% for omadacycline versus 85.1% for moxifloxacin — and in the clinically evaluable population — 92.9% for omadacycline versus 90.4% for moxifloxacin.
In addition, the drug met the European Medicines Agency co-primary endpoints in the intent-to-treat and clinically evaluable populations, with response rates of 88.4% for omadacycline compared with 85.2% for moxifloxacin and 92.5% for omadacycline versus 90.5% for moxifloxacin, in the respective populations.
Paratek intends to file a new drug application with the U.S. FDA as early as the first quarter of 2018, followed by an EMA submission later in 2018.