BOSTON, March 29, 2016 (GLOBE NEWSWIRE) — Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today that data from its omadacycline microbiology and clinical program will be presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID). The conference will be held April 9 – 12, 2016 in Amsterdam. Paratek is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry.
“The 10 posters accepted for presentation at this year’s ECCMID conference include data that span both the preclinical and clinical domains,” said Evan Loh, President and Chief Medical Officer. “These presentations build on data we have presented at previous meetings and continue to augment the broad expanse of relevant and important clinical data for omadacycline. We remain committed to working tirelessly to bring omadacycline to patients with serious community-acquired bacterial infections where resistance is of concern.”
Activity and Efficacy of Omadacycline against Clostridium difficile
Abstract #: P1325
Presenter: Oak Kim
Session Title: Paper Poster Session
Date and Time: Monday, 11 April 2016 – 13:30 – 14:30
A Pooled Analysis of Two Randomized Multicenter Evaluator-Blind Studies Comparing the Safety and Efficacy of Omadacycline and Linezolid for the Treatment of Complicated Skin and Skin Structure Infections
Abstract #: P1326
Presenter: Evan Tzanis
Session Title: Paper Poster Session
Date and Time: Monday, 11 April 2016 – 13:30 – 14:30
Bactericidal Activity of Omadacycline, a Novel Aminomethylcycline
Abstract #: P1322
Presenter: Stephen Hawser
Session Title: Paper Poster Session
Date and Time: Monday, 11 April 2016 – 13:30 – 14:30
Omadacycline, an Aminomethylcycline Antibiotic, has no Effect on QT/QTc Intervals in Healthy Subjects
Abstract #: P1321
Presenter: Stephen Villano
Session Title: Paper Poster Session
Date and Time: Monday, 11 April 2016 – 13:30 – 14:30
Effect of Age and Gender on the Pharmacokinetics of the Oral and IV Omadacycline, a New Class of Aminomethylcyclines
Abstract #: P1318
Presenter: Stephen Villano
Session Title: Paper Poster Session
Date and Time: Monday, 11 April 2016 – 13:30 – 14:30
Effects of Omadacycline on Gut Microbiota Populations and Clostridium difficile Germination, Proliferation and Toxin Production in an In Vitro Model of the Human Gut
Abstract #: P1324
Presenter: Caroline Chilton
Session Title: Paper Poster Session
Date and Time: Monday, 11 April 2016 – 13:30 – 14:30
In Vitro Bacterial and Intracellular Activity of Omadacycline against Legionella pneumophila
Abstract #: P1323
Presenter: Jacques Dubois
Session Title: Paper Poster Session
Date and Time: Monday, 11 April 2016 – 13:30 – 14:30
Omadacycline Activity Tested against European Bacterial Isolates from a Combined 2010-2011 Global Surveillance Program
Abstract #: P1317
Presenter: Robert Flamm
Session Title: Paper Poster Session
Date and Time: Monday, 11 April 2016 – 13:30 – 14:30
Population Pharmacokinetics (PPK) of Omadacycline Following Intravenous (IV) or Oral Administration to Phase 1 Subjects
Abstract #: P1320
Presenter: Scott A. VanWart
Session Title: Paper Poster Session
Date and Time: Monday, 11 April 2016 – 13:30 – 14:30
Single and Multiple-Dose Pharmacokinetics and Tolerability of Intravenous Omadacycline in Healthy Volunteers
Abstract #: P1319
Presenter: Evan Tzanis
Session Title: Paper Poster Session
Date and Time: Monday, 11 April 2016 – 13:30 – 14:30
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 in mid-2016. 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 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 statements regarding the projected availability of top-line data from Paratek’s Phase 3 clinical trials of omadacycline and the expected benefits of Paratek’s product candidates are forward-looking statements. These forward-looking statements are based upon Paratek’s current expectations and involve substantial risks and uncertainties. Paratek may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in these forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to (i) unexpected results that 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 December 31, 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.
CONTACT: CONTACTS: Media Relations: Michael Lampe (484) 575-5040 michael@michaellampeconsulting.com Investor Relations: Hans Vitzthum LifeSci Advisors, LLC. 212-915-2568
