Paratek Pharmaceuticals (PRTK) Doses First Patient in Phase 3 Study of Oral-only Omadacycline in ABSSSI

August 15, 2016 8:04 AM EDT
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Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK) announced today the dosing of the first patient in its second pivotal Phase 3 study of omadacycline in patients with acute bacterial skin and skin structure infections (ABSSSI). This Phase 3 study will assess the efficacy and safety of once-daily oral-only omadacycline compared with twice-daily oral-only linezolid in subjects with ABSSSI.

“Oral antibiotic therapies for community-acquired skin infection, when effective, are advantageous, because they can eliminate the need for a hospital stay, thereby substantially reducing the overall cost of treatment and limiting a patient’s exposure to secondary infection in the hospital setting. Unfortunately, resistance to the existing, older oral agents has led to increasing hospital visits, so there is a need for a new, effective, broad spectrum oral agent with MRSA coverage for community-acquired skin infections,” said Evan Loh, President and Chief Medical Officer, Paratek. “Omadacycline is an excellent candidate for study in these infections as it is broad spectrum, well-tolerated, and available in a once-daily oral formulation. We look forward to building on the strength of our clinical program, having already demonstrated robust efficacy and safety in our Phase 3 study of IV to oral omadacycline in ABSSSI, reported earlier this year.”

The Phase 3, randomized, double-blind, multi-center study in adults with moderate to severe ABSSSI will compare the safety and efficacy of once-daily oral omadacycline to twice-daily oral linezolid. The study is designed to enroll approximately 700 patients at approximately 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.

About Acute Bacterial Skin and Skin Structure Infections (ABSSSIs)Acute Bacterial Skin and Skin Structure Infections are responsible for more than 750,000 hospitalizations per yeari, representing a 17.3% increase in hospitalized ABSSSI patients from 2005 to 2011.ii

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