Paratek Initiates Phase 1b Study of Omadacycline in Urinary Tract Infection

Boston, Massachusetts, UNITED STATES

BOSTON, May 02, 2016 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today the dosing of the first patient in its Phase 1b study of omadacycline in patients with Urinary Tract Infections (UTI). This study will explore a range of doses of both oral and IV omadacycline. The study will evaluate the pharmacokinetic and pharmacodynamic profiles of oral only and IV-to-oral dosing regimens in female patients with cystitis, the most common form of UTI. This study will also provide initial insight into the potential for clearance of bacteria by omadacycline in patients with UTIs. Urinary tract infections represent a significant unmet need. There are more than 10 million physician visits each year for urinary tract infections, and bacteria are becoming resistant to drugs commonly used to treat UTI.

“Urinary tract infections represent a difficult clinical challenge, as they can be caused by a range of hard-to-treat Gram-positive and Gram-negative pathogens, including multi-drug resistant E. coli and vancomycin-resistant enterococci,” said Evan Loh, M.D., President and Chief Medical Officer, Paratek. “Omadacycline’s broad spectrum of activity, once-daily oral formulation, and tolerability profile would seem to make it an excellent candidate to potentially provide an alternative to quinolones as a treatment for patients with these infections, and we look forward to evaluating its potential in our development program.”

The U.S. Food and Drug Administration has designated omadacycline as a qualified infectious disease product for the treatment of complicated UTI, as well as for acute bacterial skin and skin structure infections (ABSSSI) and for community acquired bacterial pneumonia (CABP). Paratek is currently conducting Phase 3 studies of the intravenous and oral formulations of omadacycline in ABSSSI and CABP.

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 as early as the third quarter 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.

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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.


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