Paratek Release: Phase III Optic Study Microbiology Data Demonstrate Omadacycline Has Potent In Vitro Activity Against Multiple Pneumonia Pathogens, Including Resistant Bacteria
Published: Oct 06, 2017
SAN DIEGO, Oct. 06, 2017 (GLOBE NEWSWIRE) -- New microbiology data from Paratek Pharmaceuticals (Nasdaq:PRTK) show that its well-tolerated, once-daily, oral and IV, broad-spectrum investigational antibiotic, omadacycline, is active against the clinically important typical and atypical community-acquired bacterial pneumonia (CABP) pathogens. The microbiological data from the Phase 3 OPTIC (Omadacycline for Pneumonia Treatment in the Community) study, which will be presented tomorrow at IDWeek 2017, demonstrate the in vitro antibacterial activity and clinical efficacy against gram-positive and gram-negative bacterial isolates. Paratek is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry.
In the analyses, pathogens were identified at screening through blood culture, lower respiratory tract culture, urinary antigen for Legionella pneumophila or Streptococcus pneumoniae, or positive serology titers for L. pneumophila, Mycoplasma pneumoniae or Chlamydophila pneumoniae. The most frequent pathogen isolates were: S. pneumoniae (13.5%), H. influenzae (12.2%), H. parainfluenzae (8.3%), Klebsiella pneumoniae (6.5%) and S. aureus (5.7%). Omadacycline showed potent in vitro activity across all isolates.
Overall, in the OPTIC study, monotherapy with IV to once-daily oral omadacycline was effective in adult CABP patients with the most frequently isolated pathogens, including multi-drug resistant S. pneumoniae.
“These microbiology data add to our growing understanding of the clinical and in vitro activity of omadacycline, and lay a foundation for clinicians for its potential use in the CABP setting where microbiological confirmation of infection is difficult and a pathogen is only identified in less than 10 percent of patients,” said Evan Loh, M.D., President, Chief Operating Officer, and Chief Medical Officer, Paratek. “The potent activity observed in the microbiology study supports previously reported in vitro data demonstrating that omadacycline is broadly active against multiple CABP pathogens, including resistant pathogens.”
Top-Line OPTIC Study Results
The global, pivotal Phase 3 OPTIC study compared the safety and efficacy of once-daily, IV-to-oral omadacycline to IV-to-oral moxifloxacin for treating adults with CABP. In the study, 774 patients were randomized.
Omadacycline met the FDA-specified primary endpoint of statistical non-inferiority (NI) in the intent-to-treat (ITT) population (10% NI margin, 95% confidence interval) compared to moxifloxacin at the early clinical response (ECR) 72-120 hours after initiation of therapy. The ECR rates for the omadacycline and moxifloxacin treatment arms were 81.1 % and 82.7%, respectively.
Additionally, the FDA-specified secondary endpoint was the investigator assessment of response at the post treatment evaluation (PTE) visit (5-10 days after the completion of therapy) in both the ITT population (87.6% for omadacycline vs. 85.1% for moxifloxacin) and in the clinically evaluable (CE) population (92.9% for omadacycline vs. 90.4% for moxifloxacin). Rates of treatment emergent adverse events (TEAEs) were 41.1% for omadacycline vs. 48.5% for moxifloxacin.
Serious TEAEs were reported in 6.0% of omadacycline patients compared to 6.7% of moxifloxacin, and discontinuation due to TEAEs was uncommon (5.5% for omadacycline vs. 7.0% for moxifloxacin).
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.
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