UPDATE: Paratek Doses First Patient in Phase 3 Clinical Trial of Omadacycline in Acute Bacterial Skin and Skin Structure Infections

Paratek Pharmaceuticals, Inc. PRTK, a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry today announced the dosing of the first patient in its Phase 3 clinical trial of its lead drug candidate, omadacycline, for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI). This global Phase 3 study will assess the efficacy and safety of omadacycline compared with linezolid in ABSSSI. Omadacycline is the first in a new class of tetracyclines known as aminomethylcyclines, with broad-spectrum activity against Gram-positive, Gram-negative and atypical bacteria. It is being developed as a once-daily oral and intravenous antibiotic for use as empiric monotherapy when resistance is of concern. The ABSSSI study is the first of two planned Phase 3 clinical trials of omadacycline. The second trial, for the treatment of Community Acquired Bacterial Pneumonia (CABP), will begin enrolling patients later this year. "The initiation of our registration trial for ABSSSI represents an important milestone for Paratek as a company," said Michael Bigham, Chairman and Chief Executive Officer at Paratek Pharmaceuticals. "We believe that omadacycline has the potential to become an important empiric monotherapy treatment option for patients suffering from ABSSSI, CABP, urinary tract infections, and other bacterial infections when resistance is of concern." "Omadacycline is now one step closer to being available for patients with serious community-acquired bacterial infections," said Evan Loh, M.D., President and Chief Medical Officer at Paratek Pharmaceuticals. "This is an important development given the evolving bacterial resistance landscape worldwide." About the Phase 3 Study of Omadacycline in ABSSSI This Phase 3, randomized, double-blind, multi-center study will compare the safety and efficacy of omadacycline IV/PO to linezolid IV/PO for treating adults with ABSSSI. The study is designed to enroll approximately 650 adult participants in approximately 100 centers worldwide. Outcome measures defined in the protocol include efficacy as assessed by at least a 20% reduction of ABSSSI lesion size compared to baseline measurements and investigator assessment of clinical response, defined as 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.