Paratek To Complete Omadacycline Phase 3 Skin Trial Earlier Than Expected

01/05/2016

Paratek Pharmaceuticals, Inc. may report top-line data from its ongoing pivotal Phase 3 clinical trial evaluating omadacycline for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) in mid-2016. The company had previously estimated that this trial would report top-line data in the second half of 2016. The revised estimate reflects to date better-than-anticipated enrollment performance in the trial. This study, which is designed to assess the efficacy and safety of once-daily oral and intravenous formulations of omadacycline compared to linezolid in ABSSSI, enrolled its first patient in June 2015.

“We have seen significant interest by the medical community in our ongoing skin trial , which has confirmed the need for new skin agents, specifically   an agent that is broad spectrum and well-tolerated with a bioequivalent once-daily oral and IV formulation,” said Evan Loh, MD, President and Chief Medical Officer, Paratek. “The potential of omadacycline, particularly the value of a well-tolerated, once-daily oral formulation, should not be underestimated, as it appears from research to be a particularly attractive proposition to physicians treating serious community acquired skin infections where bacterial resistance is of concern. We thank every patient for their participation and we look forward to reporting the top-line efficacy and safety results mid-year.”

The Phase 3, randomized, double-blind, multi-center study will compare the safety and efficacy of IV step-down to oral treatment of both omadacycline and linezolid in adults with ABSSSI. The study is designed to enroll approximately 650 patients at approximately 100 centers worldwide. The primary efficacy endpoint as established in the protocol is defined as the number of subjects with clinical success at the early clinical response assessment 48-72 hours after the first dose of study drug. Other efficacy outcome measurements will 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 measured. 

Paratek's an ongoing Phase 3 trial of IV and oral omadacycline for community acquired bacterial pneumonia (CABP) initiated enrollment in November 2015.

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