Paratek's omadacycline meets Phase III endpoints

Paratek Pharmaceuticals Inc. (NASDAQ:PRTK) jumped $4.07 (25%) to $20.51 in early after-hours trading after its omadacycline (formerly PTK 0796) met FDA- and EMA-specified primary endpoints in the Phase III OASIS study to treat acute bacterial skin and skin structure infections (ABSSSI).

Paratek said early clinical response in omadacycline-treated patients was statistically non-inferior to Zyvox linezolid treatment at 48 to 72 hours (84.8% for omadacycline vs. 85.5% for Zyvox) in the modified intent-to-treat population (mITT) of OASIS, meeting FDA's primary efficacy endpoint. The aminomethylcycline antibiotic also met EMA's co-primary efficacy endpoints, showing non-inferiority to Zyvox in investigator-assessed clinical response at a post-treatment evaluation in the mITT (86.1% for omadacycline vs. 83.6% for Zyvox) and clinically evaluable populations (96.3% for omadacycline vs. 93.5% for Zyvox). ...