BOSTON, June 20, 2016 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today that it projects its ongoing phase 1b clinical study evaluating omadacycline in the treatment of uncomplicated urinary tract infections (uUTI) will report top-line data in the fourth quarter of 2016. The company had previously estimated that this trial would report top-line data in the first quarter of 2017. The revised estimate reflects better-than-anticipated enrollment performance in the study. This proof-of-principle study is designed to assess pharmacodynamic and pharmacokinetic parameters with several dosing regimens of oral omadacycline. The first patient was enrolled in May 2016.
About Urinary Tract Infections
Urinary tract infection is one of the most commonly diagnosed bacterial infections, and results in significant antibiotic use. Each year, UTIs result in more than 8.6 million physician visits in the United States, alone, as and as many as 1 million hospitalizations. Acute uncomplicated cystitis in the community remains one of the most common indications for prescribing antibiotics to otherwise healthy women; up to 50% of all women experience at least one such episode by 32 years of age.
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. In June 2016 Paratek announced positive efficacy data in a Phase 3 registration study in ABSSSI demonstrating the efficacy, safety and tolerability of the once-daily oral and IV formulations of omadacycline compared to linezolid. A Phase 3 registration study for community acquired bacterial pneumonia (CABP) comparing omadacycline to moxifloxacin was initiated in November 2015 and top line data is expected as early as the third quarter of 2017. A phase 1b study in uncomplicated urinary tract infections (uUTI) was initiated in May 2016. Omadacycline has been granted QIDP 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 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 Statement
Certain statements in this press release 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.
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