Paratek's omadacycline meets second Phase III endpoint

Paratek Pharmaceuticals Inc. (NASDAQ:PRTK) surged $5.85 (31%) to $24.45 in early after-hours trading on Monday after it said omadacycline (formerly PTK 0796) met FDA and EMA-specified primary endpoints in the Phase III OPTIC study to treat community-acquired bacterial pneumonia (CABP). The company said it expects to submit an NDA to FDA "as early as" 1Q18, with an EMA submission by YE18.

Paratek said omadacycline was statistically non-inferior to moxifloxacin in early clinical response at 72-120 hours after starting therapy in OPTIC's intent to treat (ITT) population, meeting its FDA-specified primary endpoint (81.1% omadacycline vs. 82.7% moxifloxacin). It also achieved non-inferiority in FDA's secondary endpoints evaluating a post-treatment evaluation visit 5-10 days after completion of treatment in the study's ITT (87.6% omadacycline vs. 85.1% moxifloxacin) and clinically evaluable (CE) populations (92.9% omadacycline vs. 90.4% moxifloxacin)...