BOSTON, April 04, 2016 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today that it has completed enrollment in the pivotal Phase 3 clinical study evaluating omadacycline for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI). The company now expects to report top-line data from this study as early as the end of June. This study, which is designed to assess the efficacy and safety of intravenous (IV) and once-daily oral formulations of omadacycline compared to linezolid in ABSSSI, enrolled its first patient in June 2015. Paratek also has an ongoing Phase 3 study of IV and once-daily oral omadacycline for community acquired bacterial pneumonia (CABP) that initiated enrollment in November 2015.
“The completion of enrollment for this Phase 3 study represents a significant milestone for Paratek, and brings us an important step closer to our goal of providing a new well-tolerated, broad-spectrum antibiotic to treat serious community-acquired bacterial infections particularly when antibiotic resistance is of concern,” said Michael Bigham, Chairman and Chief Executive Officer, Paratek. “We are pleased with how rapidly this study enrolled having only started the study last June. We look forward to sharing the top-line results in the coming months.”
The Phase 3, randomized, double-blind, multi-center study compares the safety and efficacy of omadacycline to linezolid in adults with moderate to severe ABSSSI. The study was designed to enroll approximately 650 patients at 100 centers worldwide. For the purposes of regulatory filings in the United States, 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. 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 are measured.
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 product candidate, 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. Paratek initiated a Phase 3 registration study in ABSSSI in June 2015 to determine the efficacy and safety of omadacycline compared to linezolid. Top-line data from this study is expected to be available as early as the end of June. A Phase 3 registration study for CABP comparing omadacycline to moxifloxacin was initiated in November 2015 and top-line data is expected in the second half of 2017. Omadacycline has been granted 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 (UTI), 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 designed to be 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.
For more information, visit www.paratekpharma.com.
Forward Looking Statements
Certain statements in this press release, including Paratek’s statements regarding the projected availability of top-line data from Paratek's Phase 3 clinical trials of omadacycline, are forward-looking statements. These forward-looking statements are based upon Paratek's current expectations and involve substantial risks and uncertainties. These risks and uncertainties include, but are not limited to: (i) unexpected results may cause the designs of the clinical trials to change, or the projected timelines of the trials to be extended, (ii) unexpected decline in the rates of patient enrollment in the clinical trials, (iii) unforeseen adverse effects experienced by patients resulting in a clinical hold, (iv) failure of patients to complete clinical trials, (v) risks related to regulatory oversight of the trials, (vi) the need for substantial additional funding to complete the development and commercialization of product candidates and (vii) risks that data to date and trends may not be predictive of future results. These and other risk factors are discussed under "Risk Factors" and elsewhere in Paratek's Annual Report on Form 10-K for the year ended December31, 2015 and Paratek's other filings with the Securities and Exchange Commission. Paratek expressly disclaims any obligation or undertaking to update or revise any forward-looking statements contained herein.