US-based biopharmaceutical firm Paratek Pharmaceuticals has reported positive top-line results from its Phase III clinical trial of omadacycline to treat community-acquired bacterial pneumonia (CABP) patients.
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Omadacycline is an investigational oral and intravenous (IV) broad spectrum antibiotic currently being designed for use as empiric monotherapy for patients with community-acquired bacterial infections.
The results from the trial indicated that all the US Food and Drug Administration (FDA) primary and secondary endpoints, as well as European Medical Agency (EMA) co-primary endpoints have been met.
The global, randomised, double-blind, active-controlled, multi-centre Phase III OPTIC trial evaluated the safety and efficacy of once-daily, IV-to-oral omadacycline compared to IV-to-oral moxifloxacin in 774 adult patients.
Paratek chairman and chief executive officer Michael Bigham said: “This successful study demonstrates the potential of omadacycline to treat community-acquired bacterial pneumonia, a significant and serious health issue.
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By GlobalData“This Phase III study in pneumonia, along with our previously announced successful Phase III study in skin infections, satisfy the regulatory filing requirements of our special protocol assessment with the FDA."
Omadacycline has met the primary endpoint of statistical non-inferiority (NI) and secondary endpoints at the post-treatment evaluation (PTE) visit five to ten days post-treatment completion.
The drug was also found to be safe and well-tolerated with a high response rate, and met statistical non-inferiority compared to moxifloxacin.
Paratek plans to submit a new drug application (NDA) to the FDA in the first quarter of next year and to EMA late next year.
Image: Lungs with community-acquired pneumonia. Photo: courtesy of Jtechr/Wikipedia.
