BOSTON, Jan. 18, 2017 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK), a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry, announced today that it has completed enrollment in the pivotal Phase 3 clinical study evaluating omadacycline for the treatment of Community Acquired Bacterial Pneumonia (CABP). This study, which is designed to assess the efficacy and safety of intravenous (IV) to once-daily oral omadacycline compared with moxifloxacin in subjects with CABP, enrolled its first patient in November 2015. The company expects to report top-line data from this study in the second quarter of 2017.
“The completion of enrollment for our second Phase 3 study represents another significant milestone for Paratek. Achieving this milestone in our CABP study positions Paratek to submit a new drug application as early as the first half of 2018,” said Evan Loh, M.D., President, Chief Operating Officer, and Chief Medical Officer, Paratek. “We are appreciative of the efforts of the clinical investigators, grateful to the patients who participated in this study, and very pleased with the performance of the Paratek Clinical Development organization that has enabled enrollment in this study to complete ahead of projections. We look forward to sharing the topline results from this study in the coming months.”
This Phase 3, randomized, double-blind, multi-center study is designed to compare the safety and efficacy of IV to once-daily oral (PO) omadacycline therapy to moxifloxacin IV/PO for treating adults with CABP. This study planned to enroll approximately 750 adult subjects at approximately 120 centers worldwide. The study was designed to satisfy both FDA and EMA requirements. The primary efficacy endpoint for FDA evaluation as defined in the protocol is the number of subjects with clinical success at the early clinical response assessment visit 72-120 hours after the first dose of study drug. The EMA Co-Primary Endpoints are the Investigator’s Assessment of Clinical Response 5-10 days after the completion of treatment for the Intent to Treat (ITT) and Clinically Evaluable (CE) populations. Other efficacy outcome measurements include overall survival and resolution or improvement of signs and symptoms at the post treatment evaluation visit. Safety and tolerability are being assessed by treatment-emergent adverse events, vital sign measurements, electrocardiograms, and laboratory values.
About Paratek Pharmaceuticals, Inc. Paratek Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon its expertise in novel tetracycline chemistry. Paratek's lead Phase 3 product candidate, omadacycline, is the first in a new class of tetracyclines known as aminomethylcyclines, with broad-spectrum activity against Gram-positive, Gram-negative, atypical and anaerobic bacteria. In addition to the Phase 3 study in CABP, the Phase 3 program for omadacycline includes two other studies: 1) in June 2016 Paratek announced positive efficacy data in a Phase 3 registration study in acute bacterial skin and skin structure infections (ABSSSI) demonstrating the efficacy and safety of intravenous to once-daily oral omadacycline compared to IV/PO linezolid; 2) A second Phase 3 registration study in ABSSSI comparing once-daily oral-only dosing of omadacycline to twice-daily oral-only dosing of linezolid (enrollment initiated in August 2016). Top line data from this oral-only phase 3 registration ABSSSI study are expected as early as the second quarter of 2017. A Phase 1B study in uncomplicated urinary tract infections (UTI) reported positive top-line PK proof-of-principle data in November 2016. In October 2016, Paratek announced a research agreement with the U.S. Department of Defense to explore the utility of omadacycline against pathogenic agents including plague and anthrax. Omadacycline has been granted Qualified Infectious Disease Product designation and Fast Track status by the U.S. Food and Drug Administration.
Omadacycline is a new once-daily oral and IV, well-tolerated broad spectrum antibiotic being developed for use as empiric monotherapy for patients suffering from 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.
Paratek's second Phase 3 product candidate, sarecycline, is a well-tolerated, once-daily, oral, narrow spectrum tetracycline-derived antibiotic with potent anti-inflammatory properties for the potential treatment of acne and rosacea in the community setting. Allergan owns the U.S. rights for the development and commercialization of sarecycline. Paratek retains all ex-U.S. rights. Allergan initiated two identical Phase 3 registration studies in December 2014 for sarecycline for the treatment of moderate to severe acne vulgaris. Top line Phase 3 data are expected in early 2017.
For more information, visit www.paratekpharma.com.
