“We have seen significant interest by the medical community in our ongoing skin trial, which has confirmed the need for new skin agents, specifically an agent that is broad spectrum and well-tolerated with a bioequivalent once-daily oral and IV formulation,” said Evan Loh, M.D., President and Chief Medical Officer, Paratek. “The potential of omadacycline, particularly the value of a well-tolerated, once-daily oral formulation, should not be underestimated, as it appears from research to be a particularly attractive proposition to physicians treating serious community acquired skin infections where bacterial resistance is of concern. We thank every patient for their participation and we look forward to reporting the top-line efficacy and safety results mid-year.”

The co-primary endpoints for the European Medicines Agency were an assessment of clinical response at the post-treatment evaluation (PTE) in the mITT and clinically evaluable (CE) populations. In both groups, omadacycline again demonstrated non-inferiority to linezolid. In the mITT population at PTE, the clinical success rates for omadacycline and linezolid were 86.1% and 83.6%, respectively. In the CE population at PTE, the clinical success rates were 96.3% and 93.5%, respectively. Omadacycline showed comparable clinical success rates to linezolid across the most common ABSSSI pathogens, including methicillin-resistant Staphylococcus aureus (MRSA).