The first patient has been dosed in Paratek Pharmaceuticals, Inc.’s second pivotal Phase 3 study of omadacycline for acute bacterial skin and skin structure infections (ABSSSI).

Omadacycline is a new once-daily oral and IV, well-tolerated broad spectrum antibiotic being developed for use as empiric monotherapy for patients who have serious community-acquired bacterial infections, such as acute bacterial skin and skin structure infections, community acquired bacterial pneumonia, urinary tract infections and other community-acquired bacterial infections, particularly when antibiotic resistance is of concern to prescribing physicians.

It has been granted Qualified Infectious Disease Product designation and Fast Track status by the U.S. Food and Drug Administration.

The study will assess the efficacy and safety of once-daily oral-only omadacycline compared with twice-daily oral-only linezolid in subjects with ABSSSI.

Top line data are expected as early as the second quarter of 2017.

The study will enroll approximately 700 patients at about 60 centers. For the purposes of regulatory filings in the United States, the primary efficacy endpoint defined in the protocol is the number of subjects with clinical success at the early clinical response assessment 48-72 hours after the first dose of study drug. For regulatory filings in the European Union, the primary endpoint will be clinical response at the post therapy evaluation, also known as ‘test of cure’. Other efficacy outcome measurements include investigator assessment of clinical response, overall survival and resolution or improvement of signs and symptoms at the post-treatment evaluation visit (7-14 days after the last day of therapy). In addition, safety and tolerability as assessed by treatment-emergent adverse events, vital sign measurements, ECGs, and laboratory values will be assessed.