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BOSTON, Sept. 25, 2018 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK) announced today that new data from its omadacycline clinical and microbiology programs will be presented at IDWeek 2018 taking place in San Francisco from October 3 – 7. Omadacycline is an investigational once-daily oral and intravenous (IV) broad spectrum antibiotic currently under review by the U.S. Food and Drug Administration for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).
“Sharing the results from our clinical program with practicing clinicians continues to be a priority,” said Evan Loh, M.D., President, Chief Operating Officer, and Chief Medical Officer, Paratek. “These presentations add to the growing body of evidence of omadacycline's utility against relevant pathogens and serious infections such as CABP and ABSSSI. Notably, we will share an analysis of omadacycline’s clinical efficacy against a broad collection of clinical isolates with known tetracycline resistance and improvement in quality of life in patients with ABSSSI.”
Friday, October 5
12:30 p.m. – 1:45 p.m. PDT (3:30 p.m. – 4:45 p.m. EDT)
Room: S Poster Hall
Poster Abstract Session: Novel Agents
Omadacycline for Acute Bacterial Skin and Skin Structure Infections: Integrated Analysis of Randomized Clinical Trials
Poster #: 1347; Presenter: G. Sakoulas
Improvement in Quality of Life for Adults with Acute Bacterial Skin and Skin Structure Infections Following Treatment with Omadacycline or Linezolid
Poster #: 1356; Presenter: T. Goss
Efficacy of Omadacycline against Molecularly Characterized Gram-Positive and Gram-Negative Pathogens Causing Infections in the Phase 3 CABP and ABSSSI Clinical Trials
Poster #: 1364; Presenter: R. Mendes
Integrated Safety Summary of Omadacycline: A Novel Aminomethylcycline Antibiotic
Poster #: 1374; Presenter: S. Opal
Omadacycline In Vitro Activity against a Molecularly Characterized Collection of Clinical Isolates with Known Tetracycline Resistance Mechanisms
Poster #: 1377; Presenter: R. Mendes
Poster Abstract Session: Respiratory Infections: CAP
Hospital Admission Patterns in Adult Patients with Community-acquired Bacterial Pneumonia who Received Ceftriaxone and a Macrolide by Pneumonia Severity Index Score
Poster #: 1462; Presenter: T. Lodise
Omadacycline is a novel investigational antibiotic with both once-daily intravenous (IV) and oral formulations being developed for the treatment of community-acquired bacterial pneumonia (CABP), acute bacterial skin and skin structure infections (ABSSSI), and urinary tract infections (UTI). A modernized tetracycline, omadacycline is specifically designed to overcome tetracycline resistance and exhibits activity across a broad spectrum of bacteria, including Gram-positive, many Gram-negative, anaerobes, atypical bacteria, and other drug-resistant strains.
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 CABP, ABSSSI, and UTI. The FDA has accepted the New Drug Applications for CABP and ABSSSI and has granted omadacycline priority review. Paratek is also preparing a marketing authorization application 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 also is being studied against pathogenic agents causing infectious diseases of public health and biodefense importance, including plague and anthrax.
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 broad-spectrum once-daily intravenous and oral antibiotic being developed for the treatment of serious community-acquired bacterial infections, including community-acquired bacterial pneumonia, acute bacterial skin and skin structure infections, and urinary tract infections.
Paratek’s second Phase 3 product candidate, SEYSARA™ (sarecycline), is being developed by Almirall, SA in the U.S. as a new once-daily oral therapy for the treatment of acne. Almirall 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. The PDUFA date for SEYSARA is in the second half of 2018. 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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