Paratek Pharmaceuticals says Omadacycline met FDA-specified primary endpoint
New microbiology data from Paratek Pharmaceuticals show that its well-tolerated, once-daily, oral and IV, broad-spectrum investigational antibiotic, omadacycline, is active against the clinically important typical and atypical community-acquired bacterial pneumonia, or CABP, pathogens. The microbiological data from the Phase 3 OPTIC, or Omadacycline for Pneumonia Treatment in the Community, study, which will be presented tomorrow at IDWeek 2017, demonstrate the in vitro antibacterial activity and clinical efficacy against gram-positive and gram-negative bacterial isolates. Paratek is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry. In the analyses, pathogens were identified at screening through blood culture, lower respiratory tract culture, urinary antigen for Legionella pneumophila or Streptococcus pneumoniae, or positive serology titers for L. pneumophila, Mycoplasma pneumoniae or Chlamydophila pneumoniae. The most frequent pathogen isolates were: S. pneumoniae, H. influenzae, H. parainfluenzae, Klebsiella pneumoniae and S. aureus. Omadacycline showed potent in vitro activity across all isolates. Overall, in the OPTIC study, monotherapy with IV to once-daily oral omadacycline was effective in adult CABP patients with the most frequently isolated pathogens, including multi-drug resistant S. pneumoniae. The global, pivotal Phase 3 OPTIC study compared the safety and efficacy of once-daily, IV-to-oral omadacycline to IV-to-oral moxifloxacin for treating adults with CABP. In the study, 774 patients were randomized. Omadacycline met the FDA-specified primary endpoint of statistical non-inferiority, or NI, in the intent-to-treat, or ITT, population compared to moxifloxacin at the early clinical response, or ECR, 72-120 hours after initiation of therapy. The ECR rates for the omadacycline and moxifloxacin treatment arms were 81.1 % and 82.7%, respectively. Additionally, the FDA-specified secondary endpoint was the investigator assessment of response at the post treatment evaluation, or PTE, visit in both the ITT population and in the clinically evaluable, or CE, population. Rates of treatment emergent adverse events, or TEAEs, were 41.1% for omadacycline vs. 48.5% for moxifloxacin.