Paratek Pharmaceuticals has reported positive safety and efficacy data from a Phase III clinical trial (OPTIC) of its investigational antibiotic, omadacycline, for community-acquired bacterial pneumonia (CABP).
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Omadacycline is being developed as a once-daily, broad-spectrum empiric monotherapy in intravenous (IV) and oral formulations.
The results showed that the investigational antibiotic is well-tolerated and actively targets clinically important typical and atypical CABP pathogens.
OPTIC is designed to compare the safety and efficacy of omadacycline with moxifloxacin in 774 adults with CABP.
Omadacycline was found to be effective in patients with most commonly isolated pathogens such as multi-drug resistant Streptococcus pneumoniae.
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By GlobalDataParatek Pharmaceuticals president chief operating officer and chief medical officer Evan Loh said: “These microbiology data add to our growing understanding of the clinical and in-vitro activity of omadacycline, and lay a foundation for clinicians for its potential use in the CABP setting where microbiological confirmation of infection is difficult and a pathogen is only identified in less than 10% of patients.
“The potent activity observed in the microbiology study supports previously reported in-vitro data, demonstrating that omadacycline is broadly active against multiple CABP pathogens, including resistant pathogens.”
The OPTIC trial met the primary endpoint of statistical non-inferiority (NI) in the intent-to-treat (ITT) population at the early clinical response (ECR) 72-120 hours following initiation of treatment.
Paratek further reported that omadacycline demonstrated a consistent safety and efficacy profile during three sub-analyses of Phase III OASIS-1 trial conducted for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in subjects with comorbid conditions.
Image: Lungs with community-acquired pneumonia. Photo: courtesy of Jtechr.
