Data Presented During “New Insights in Acute Pulmonary Infections” Oral Session at American Thoracic Society 2018 International Conference
BOSTON, May 22, 2018 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (PRTK), a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry, today presented a new analysis of the Phase 3 OPTIC study of omadacycline, its first in class aminomethylcycline, versus moxifloxacin, a fluoroquinolone, for the treatment of community-acquired bacterial pneumonia (CABP). OPTIC efficacy results were presented by measures of disease severity. The data showed similar, high rates of response for the early clinical response (ECR) and post therapy evaluation (PTE, also known as test-of-cure) endpoints in both the omadacycline and moxifloxacin treatment groups, regardless of the severity of disease. The results were presented today as an oral session at the American Thoracic Society 2018 International Conference.
“This analysis underscores that across the range of disease severity studied, omadacycline demonstrated high rates of clinical success at the early response timepoint, in hospitalized CABP patients. The implications for clinical practice are that achieving clinical success at an early timepoint could potentially result in transition from intravenous to oral omadacycline allowing for hospital discharge,” said Paul McGovern, Vice President of Clinical Affairs, Paratek. “Omadacycline, if approved, will provide physicians with a new option to treat patients with CABP.”
Safety findings were previously disclosed in October of 2017 at IDWeek 2017 with the top-line OPTIC study results, and showed that omadacycline was generally safe and well-tolerated.
About the OPTIC study
OPTIC (Omadacycline for Pneumonia Treatment in the Community) was a Phase 3, randomized (1:1), double-blind, global study comparing the safety and efficacy of once-daily, IV-to-oral omadacycline to IV-to-oral moxifloxacin in treating adults with radiologically confirmed CABP. A total of 774 patients were randomized, with 386 in the omadacycline group and 388 in the moxifloxacin group. After a minimum of 3 days of intravenous treatment subjects could transition to oral treatment if clinical stability criteria were met.
The primary efficacy endpoint for FDA evaluation is the number of study patients reaching ECR, defined as survival, no receipt of rescue antibacterial therapy and improvement in at least two of four CABP symptoms (cough, sputum production, pleuritic chest pain, dyspnea) without deterioration in any of these 4 symptoms 3-5 days after receiving their first dose of treatment.
Other efficacy outcome measurements included investigator assessment of PTCR/overall success, defined overall survival and resolution or improvement of signs and symptoms at the post treatment evaluation visit 5-10 days after the last day of therapy. In addition, safety and tolerability as assessed by treatment-emergent adverse events, vital sign measurements, ECGs, and laboratory values were measured.
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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