Paratek antibiotic heading for submission

Paratek Pharmaceuticals Inc. (NASDAQ:PRTK) said omadacycline (formerly PTK 0796) met FDA and EMA-specified co-primary endpoints in the Phase III OASIS-2 study to treat acute bacterial skin and skin structure infections (ABSSSIs).

The company hopes to submit an NDA in 1Q18 for the aminomethylcycline antibiotic to treat ABSSSI and community-acquired bacterial pneumonia (CABP). Omadacycline has also met the primary endpoints in the Phase III OASIS-1 and OPTIC trials to treat ABSSSI and CABP, respectively (see BioCentury Extra, June 16, 2016 & April 3, 2017)...