Paratek’s pneumonia antibiotic succeeds in phase 3 trial
A phase 3 study of Paratek Pharmaceuticals' omadacycline has met its primary and secondary endpoints in the treatment of patients with community-acquired bacterial pneumonia (CABP).
The study, dubbed OPTIC, assessed the safety and efficacy of once-daily, IV-to-oral omadacycline in comparison to IV-to-oral moxifloxacin in the treatment of CABP in adults.
In the clinical trial featuring 774 randomized patients, the primary endpoint specified by the US Food and Drug Administration (FDA) which was met by omadacycline was the statistical non-inferiority (NI) in the intent-to-treat (ITT) population at the early clinical response (ECR) 3-5 days after starting treatment.
For the omadacycline arm, the ECR rate was 81.1% in comparison to 82.7% recorded by the moxifloxacin treatment arm.
The secondary endpoints of the OPTIC trial assessed Paratek’s investigational antibiotic at the post treatment evaluation (PTE) follow up 5-10 days after completing the treatment in both the ITT patient population and in the clinically evaluable (CE) population. Also specified by the FDA, the secondary endpoints for omadacycline demonstrated statistical non-inferiority.
On par with its prior studies, Paratek’s pneumonia drug was shown to be generally safe and well tolerated during the OPTIC phase 3 trial.
Paratek president, COO and chief medical officer Evan Loh said: “We now have experience with omadacycline in more than 1,500 patients in our clinical program and we are very pleased with the safety, tolerability, and efficacy profile that we have seen to date.”
The findings from the OPTIC trial mark the second positive phase 3 results for omadacycline, which Paratek intends to use in its marketing applications to the FDA and the European Medicines Agency (EMA).
Paratek is targeting to file a New Drug Application (NDA) in the US in the first quarter of 2018.