Phase III OPTIC study of PTK 0796 shows high response rate in community-acquired bacterial pneumonia.- Paratek Pharma.

Paratek Pharmaceuticals presented an analysis of data from the Company�s Phase III OPTIC study of PTK 0796 (omadacycline) vs. moxifloxacin for the treatment of community-acquired bacterial pneumonia (CABP) using the European Medicines Agency (EMA) guidance for approval of new treatments for CABP. Omadacycline demonstrated a high response rate and met statistical non-inferiority to moxifloxacin for both populations using a prespecified 97.5% confidence interval. High success rates were observed with response rates of 88.4% (omadacycline) vs. 85.2% (moxifloxacin) in the ITT population and 92.5% (omadacycline) vs. 90.5% (moxifloxacin) in the CE population. The secondary endpoints for the EMA focus on clinical success by pathogen for each study participant in the microITT and microbiologically evaluable (ME) populations. The results were comparable for the ME population. Clinical success rates by pathogen were high and similar between treatment groups for common pneumonia pathogens including Gram-positive (omadacycline 87.3% vs. moxifloxacin 86.3%) and Gram-negative pathogens (omadacycline 83.6% vs. moxifloxacin 83.3%), and atypical pathogens (omadacycline 93.3% vs. moxifloxacin 92.3%). Treatment discontinuation rates were low in both arms of the study. An additional sub-analysis of OPTIC reported on the efficacy of omadacycline in CABP across geographic regions.

These findings were presented at the annual meeting of the European Congress of Clinical Microbiology and Infectious Diseases, ECCMID 2018 in Madrid, Spain. Omadacycline is an investigational once-daily oral and intravenous (IV) monotherapy antibiotic for the treatment of community-acquired infections including CABP and acute bacterial skin and skin structure infections (ABSSSI). Paratek plans to submit its marketing authorizations for omadacycline in Europe in the second half of 2018.