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Paratek Demonstrates Breadth of Omadacycline Clinical and Microbiological Data at ASM Microbe 2018
Poster presentations will include new analysis of efficacy against drug resistant S. aureus in skin infections
BOSTON, June 07, 2018 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today that data from its omadacycline clinical and microbiology programs will be presented at the American Society for Microbiology’s annual ASM Microbe 2018 meeting taking place from June 7-11 in Atlanta, GA. The data continue to highlight the robust efficacy and safety profile of omadacycline, an investigational once-daily oral and intravenous (IV) monotherapy antibiotic for the treatment of community-acquired infections including community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).
“The number and variety of presentations at ASM microbe this year demonstrate the breadth of potential utility of once-daily, IV and oral omadacycline against a number of virulent pathogens and in a variety of infection types,” said Evan Loh, M.D., President, Chief Operating Officer, and Chief Medical Officer, Paratek. “We are pleased to share these studies at the ASM Microbe meeting, with the clinicians who are on the front lines of treating serious community-acquired infections each day.”
Paratek Presentations on Saturday, June 9, 2018 at 11:00 a.m. – 1:00 p.m. EDT
Poster Session 236: Pharmacological Studies of Antimicrobial Agents Pre-NDA (Phase 2/3): New Agents Between Phase 2 and FDA Approval
Pharmacokinetic-pharmacodynamic Characterization of Omadacycline against Haemophilus Influenzae Using A One-Compartment In Vitro Infection Model
Abstract #: 624; Presenter: B.D. VanScoy
Pharmacokinetic-Pharmacodynamic (PK-PD) Target Attainment Analyses Evaluating Omadacycline Dosing Regimens for the Treatment of Patients with Community-Acquired Bacterial Pneumonia (CABP) for Streptococcus Pneumoniae (SP) and H. influenzae (HI)
Poster #: 625; Presenter: S.M. Bhavnani
In Vitro Activity of Omadacycline against Chlamydia Pneumoniae
Poster #: 626; Presenter: S.A. Kohlhoff
Omadacycline In Vitro Activity against Skin and Skin Structure, Respiratory, and Urinary Tract Pathogens Collected from the U.S. and Europe During the Sentry Surveillance Program (2017)
Poster #: 627; Presenter: M.D. Huband
Population Pharmacokinetic (PK) Analyses of Omadacycline Using Phase 1 and Phase 3 Data
Poster #: 628; Presenter: E.A. Lakota
Poster Session 239: Clinical Studies of Adult Infectious Diseases: Staphylococcal and Other Gram-positive Infections
Efficacy of Omadacycline and Linezolid against Characterized Drug Resistant S. Aureus from Combined Phase 3 ABSSSI Studies
Poster #: 701; Presenter: J.N. Steenbergen
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 (UTI). 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, and UTI. Paratek has completed Phase 3 development activities for omadacycline in CABP and ABSSSI, and its New Drug Applications to the U.S. FDA have been accepted for priority review. The Company plans to submit a marketing authorization in the European Union in the second half of this year. Paratek has entered into a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in 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 product candidate, SEYSARA™ (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 Seysara and its new drug application was accepted for review by the U.S. FDA in December 2017. 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, prospects, potential and expected results, including statements about the development, launch and commercialization of omadacycline, the potential for omadacycline to treat ABSSSI, CABP, UTI and other serious community-acquired bacterial infections, the prospect of omadacycline providing broad-spectrum activity, our ability to obtain regulatory approval of omadacycline and our anticipated transition to a commercial stage organization. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as “potential,” “prospective,” “prepare” 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, 2017, 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.
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