- First oral presentation of the results of OASIS-2, the Phase 3 omadacycline oral-only study in ABSSSI
- Poster presentations include new microbiology analyses from OASIS-2
BOSTON, April 12, 2018 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today that data from its omadacycline clinical and microbiology programs will be presented at the annual meeting of the European Congress of Clinical Microbiology and Infectious Diseases, ECCMID 2018, to be held April 21 – 24 in Madrid, Spain. The data continue to highlight the compelling 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).
“We are excited to share data from nine posters and one oral presentation at ECCMID this year. Each of these presentations add to the growing body of evidence of omadacycline's utility against relevant pathogens and life-threatening infections such as CABP and ABSSSI,” said Evan Loh, M.D., President, Chief Operating Officer, and Chief Medical Officer, Paratek. “These considerable efforts represent our ongoing commitment to making our data accessible to practicing physicians.”
Paratek’s Phase 3 study of the oral-only dosing of omadacycline in ABSSSI is known as the Omadacycline Acute Skin and Skin Structure Infections Study (OASIS-2).
Paratek Presentations on Saturday, April 21, 2018 at 3:30 – 4:30 p.m. CEST (9:30 – 10: 30 a.m. EDT)
Poster Session: Clinical Trial Experience – New Antibacterial Agents
Omadacycline gastrointestinal effects – an integrated safety analysis from the Phase 3 ABSSSI and CABP studies
Abstract #: P0271; Presenter: O. Cornely
Efficacy of omadacycline versus moxifloxacin in treating subjects from different geographic regions with community-acquired bacterial pneumonia (CABP)
Abstract #: P0272; Presenter: L. Garrity-Ryan
Effects of oral omadacycline versus oral linezolid on lesion size and local signs of ABSSSI in the Phase 3 OASIS-2 study
Abstract #: P0273; Presenter: E. Tzanis
Efficacy of oral omadacycline versus linezolid for treating adult subjects with ABSSSI: analysis by infection type and pathogen in the OASIS-2 study
Abstract #: P0274; Presenter: M. Bassetti
Omadacycline versus moxifloxacin in the treatment of adults with community-acquired bacterial pneumonia (CABP): efficacy analysis according to EMA requirements
Abstract #: P0275; Presenter: A. Torres
Paratek Presentation on Sunday, April 22, 2018 at 11:54 – 11:57 a.m. CEST (5:54 – 5:57 a.m. EDT)
Oral Session: Snapshot on Pre-registration Clinical Trials
A Phase 3 randomized, double-blind, multi-centre study to compare the safety and efficacy of oral omadacycline to oral linezolid for treating adult subjects with ABSSSI (OASIS-2 study)
Abstract #: O0425; Presenter: P. McGovern
Paratek Presentations on Monday, April 23, 2018 at 1:30 – 2:30 p.m. CEST (7:30 – 8:30 a.m. EDT)
Poster Session: Resistance in Various Gram-positives
In vitro activity of omadacycline against resistant Streptococcus pneumoniae and Haemophilus influenzae
Abstract #: P1821; Presenter: J. Dubois
Activity of omadacycline and comparators against Gram-positive and -negative clinical isolates (including resistant organism subsets) collected in 2017 from patients in European medical centres: SENTRY Surveillance Program Results
Abstract #: P1822; Presenter: M. Huband
In vitro activity of omadacycline against resistant Staphylococcus aureus
Abstract #: P1829; Presenter: J. Dubois
In addition, Zai Lab, Paratek’s partner in the Greater China region, will present one poster on Saturday, April 21, 2018 from 3:30 – 4:30 p.m. CEST (9:30 – 10: 30 a.m. EDT).
Poster Session: Activity of New or Re-purposed Non-beta-lactam Drugs Against Gram-negatives
Antimicrobial activity of omadacycline tested against clinical bacteria isolates collected from hospitals in China, including Hong Kong, and Taiwan: results from the SENTRY Antimicrobial Surveillance Program (2013-2016)
Abstract #: P0102; Presenter: H. Sader
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 an investigational 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 (FDA) for the target indications of ABSSSI, CABP, uncomplicated urinary tract infections (uUTI) and complicated urinary tract infections (cUTI). Paratek’s New Drug Applications have been accepted for priority review by the U.S. FDA and the Company is preparing a marketing authorization in the European Union. 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 is also 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, 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, 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, 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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