Poster Presentation: Analysis of Microbiological Data from Phase 3 Community-acquired Bacterial Pneumonia Clinical Study
BOSTON, Sept. 25, 2017 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today that new data from its omadacycline clinical and microbiology programs will be presented at IDWeek 2017 taking place in San Diego from October 4 – 8. In addition to the poster presentations, Paratek’s Vice President of Clinical Development and Medical Affairs, Paul McGovern, M.D., will provide an overview of omadacycline during the New Antibiotics: What’s in the Pipeline symposium. Paratek is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry.
“Our clinical program continues to demonstrate a compelling profile for once-daily oral and IV omadacycline and underscores our commitment to bringing this new antibiotic treatment option to physicians and patients given the tremendous need, particularly for new safe and effective oral options,” said Evan Loh, M.D., President, Chief Operating Officer, and Chief Medical Officer, Paratek. “As we move closer to initiating our rolling submission in December of this year, we remain committed to sharing data about the utility of omadacycline with prescribers who are in need of new, effective oral agents to combat serious community-acquired infections.”
Thursday, October 5 at 2:36 p.m. – 2:45 p.m. PDT (5:36 p.m. – 5:45 p.m. EDT)
Symposium: New Antibiotics: What’s in the Pipeline
Omadacycline, the First Aminomethylcycline
Session #: 861; Presenter: P. McGovern
Friday, October 6, 2017 at 12:30 p.m. – 2:00 p.m. PDT (3:30 p.m. – 5:00 p.m. EDT)
Poster Abstract Session: Expanded Spectrum - New Antimicrobial Susceptibility Testing
In Vitro Activity of Omadacycline and Comparator Compounds against Gram-positive Isolates Collected in the USA During 2016 as Part of a Global Surveillance Program
Poster #: 1223; Presenter: R. Flamm
Poster Abstract Session: Preclinical Study with New Antibiotics and Antifungals
In vivo Pharmacodynamic Evaluation of Omadacycline (PTK 0796) against Staphylococcus aureus (SA) in the Murine Thigh Infection Model
Poster #: 1531; Presenter: A. Lepak
Saturday, October 7, 2017 at 12:30 p.m. – 2:00 p.m. PDT (3:30 p.m. – 5:00 p.m. EDT)
Poster Abstract Session: Clinical Study with New Antibiotics and Antifungals
Efficacy and Safety of Omadacycline in Chronic Kidney Disease (CKD) Patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI): A Subgroup Analysis from the OASIS Trial
Poster #: 1834; Presenter: T. File
Efficacy and Safety of Omadacycline in Patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) and High Body Mass Index or Diabetes: A Subgroup Analysis from the OASIS Trial
Poster #: 1838; Presenter: M. Wilcox
A Pharmacometric Comparison of Omadacycline and Tigecycline Epithelial Lining Fluid (ELF) Penetration
Poster #: 1850; Presenter: E. Lakota
Analysis of the Microbiological data from the Omadacycline (OMC) Phase 3 Community-Acquired Bacterial Pneumoniae (CABP) trial: The OPTIC study
Poster #: 1875; Presenter: J. Steenbergen
A Phase 3 Randomized, Double-Blind, Multi-Center Study to Compare the Safety and Efficacy of IV to Oral Omadacycline to Moxifloxacin for the Treatment of Adult Subjects with CABP (The OPTIC Study)
Poster #: 1883; Presenter: I. Mitha
Efficacy and Safety of Omadacycline in Intravenous Drug Using (IVDU) and Hepatitis C-Positive (HCV+) Patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI): A Subgroup Analysis from the OASIS Trial
Poster #: 1885; Presenter: C. Ohl
Cardiac Safety of Omadacycline in the IV/oral Phase 3 Acute Bacterial Skin and Skin Structure Infection (ABSSSI) and in the IV/oral Phase 3 Community-acquired Bacterial Pneumonia (CABP) Studies
Poster #: 1886; Presenter: P. McGovern
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. The Company’s lead product candidate, omadacycline, is a new, once-daily oral and intravenous broad-spectrum antibiotic being developed for the treatment of serious community-acquired bacterial infections, including community-acquired bacterial pneumonia (CABP), acute bacterial skin and skin structure infections (ABSSSI), and urinary tract infections. Omadacycline has been granted Qualified Infectious Disease Product designation and Fast Track status by the U.S. Food and Drug Administration for the target indications of ABSSSI, CABP, uUTI and cUTI. Paratek has completed Phase 3 development activities for omadacycline in CABP and ABSSSI and is preparing to submit marketing applications in the United States and European Union. Paratek has licensed rights for omadacycline to Zai Lab for the greater China region, and retains all remaining global rights.
Under a research agreement with the U.S. Department of Defense, omadacycline also is being studied against pathogenic agents causing infectious diseases of public health and biodefense importance, including plague and anthrax.
Paratek's second Phase 3 product candidate, sarecycline, is being developed by Allergan in the U.S. as a new once-daily oral therapy for the treatment of acne. Allergan has completed Phase 3 development activities for sarecycline and is preparing a new drug application for submission to the U.S. Food and Drug Administration. Paratek retains all ex-U.S. rights to sarecycline.
Recognizing the serious threat of bacterial infections, Paratek is dedicated to providing solutions that enable positive outcomes and lead to better patient stories.
For more information, visit www.paratekpharma.com or follow @ParatekPharma on Twitter.
Forward Looking Statements
This press release contains forward-looking statements including statements related to our overall strategy, product candidates, clinical studies, prospects, potential and expected results, including statements about the timing of advancing omadacycline and otherwise preparing for clinical studies, the timing of enrollment in our clinical studies and our reporting of the results of such studies, the potential for omadacycline to serve as an empiric monotherapy treatment option for patients suffering from ABSSSI, CABP, UTI, and other bacterial infections when resistance is of concern, the prospect of omadacycline providing broad-spectrum activity, and our ability to obtain regulatory approval of omadacycline. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "believe," "expect," "well positioned," "look forward," "anticipated," "continued," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our 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. These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2016, and our other filings with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.
||LifeSci Advisors, LLC.