Company on track to file marketing authorization applications in the European Union in the second half of 2018
Data on utility in geographic regions also presented
MADRID, Spain, April 23, 2018 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (PRTK) presented an analysis of data from the Company’s Phase 3 OPTIC study of omadacycline vs. moxifloxacin for the treatment of community-acquired bacterial pneumonia (CABP) using the European Medicines Agency (EMA) guidance for approval of new treatments for CABP. Omadacycline is an investigational once-daily oral and intravenous (IV) monotherapy antibiotic for the treatment of community-acquired infections including CABP and acute bacterial skin and skin structure infections (ABSSSI). Paratek plans to submit its marketing authorizations for omadacycline in Europe in the second half of 2018.
An additional sub-analysis of OPTIC reported on the efficacy of omadacycline in CABP across geographic regions. These findings were presented at the annual meeting of the European Congress of Clinical Microbiology and Infectious Diseases, ECCMID 2018 in Madrid, Spain.
“These study results demonstrate the potential of omadacycline to treat community-acquired bacterial pneumonia, a leading cause of death globally, in the context of the European Medicines Agency’s rigorous evaluation criteria,” said Evan Loh, M.D., President, Chief Operating Officer, and Chief Medical Officer at Paratek. “We look forward to sharing these data with the EMA as we move forward to the MAA filing later this year.”
The global, pivotal Phase 3 clinical study known as OPTIC (Omadacycline for Pneumonia Treatment in the Community), compared the safety and efficacy of once-daily, IV-to-oral omadacycline to IV-to-oral moxifloxacin for treating adults with CABP.
For the EMA analyses, 660 subjects with Pneumonia Severity Index (PORT) Class III and IV were included. The co-primary endpoints for the EMA were non-inferiority in the intent-to-treat (ITT) and clinically evaluable (CE) CABP populations at Post Therapy Evaluation (PTE), 5 to 10 days following the last dose. Omadacycline demonstrated a high response rate and met statistical non-inferiority to moxifloxacin for both populations using a prespecified 97.5% confidence interval. High success rates were observed with response rates of 88.4% (omadacycline) vs. 85.2% (moxifloxacin) in the ITT population and 92.5% (omadacycline) vs. 90.5% (moxifloxacin) in the CE population.
The secondary endpoints for the EMA focus on clinical success by pathogen for each study participant in the microITT and microbiologically evaluable (ME) populations. The results were comparable for the ME population. Clinical success rates by pathogen were high and similar between treatment groups for common pneumonia pathogens including Gram-positive (omadacycline 87.3% vs. moxifloxacin 86.3%) and Gram-negative pathogens (omadacycline 83.6% vs. moxifloxacin 83.3%), and atypical pathogens (omadacycline 93.3% vs. moxifloxacin 92.3%).
Treatment discontinuation rates were low in both arms of the study.
Additional OPTIC Sub-Analyses Expands Body of Evidence for Omadacycline
Regional distribution of infection type remained consistent across OPTIC study locations in Western Europe/North America, Eastern Europe and Rest of World (Latin America, Asia-Pacific, Israel, Turkey and South Africa), with Streptococcus pneumoniae and Haemophilus influenzae emerging as the most common cultured pathogens. Mycoplasma pneumoniae was the most common atypical pathogen.
Clinical success at PTE among the ITT population (n=774) for omadacycline vs moxifloxacin was 85.7% (n=91) vs 80.4% (n=92) in Western Europe/North America and 90.4% (n=249) vs 85.5% (n=248) in Eastern Europe. Moxifloxacin showed a higher clinical success rate compared to omadacycline (MOX: 91.7%; n=48 vs OMC: 76.1%; n=46) in the Rest of World however the small sample sizes make it difficult to draw any conclusions from the numeric difference.
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, 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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