Paratek planning regulatory submissions for omadacycline antibiotic

Paratek Pharmaceuticals Inc. (NASDAQ:PRTK) reported top-line data from 720 patients with acute bacterial skin and skin structure infections (ABSSSIs) in the modified intent-to-treat (mITT) population of the Phase III OASIS-2 trial showing that once-daily oral omadacycline for 7-14 days met the FDA-defined primary endpoint. The company plans to submit NDAs to FDA in 1Q18 and an MAA to EMA later in 2018 for omadacycline to treat ABSSSIs and community-acquired bacterial pneumonia (CABP) (see BioCentury, June 20, 2016 & April 7, 2017).

On the FDA-defined primary endpoint, omadacycline was non-inferior to twice-daily Zyvox linezolid in early clinical response, defined as survival with a ≥20% reduction in ABSSSI lesion size from baseline, at 48-72 hours after the start of treatment (87.5% vs. 82.5%). The non-inferiority margin was 10%. The mITT population excluded patients with a Gram-negative causative pathogen at screening...