– Oral presentation: Phase 3 omadacycline IV-to-oral ABSSSI results (OASIS)
– Poster presentation: Health Economics – omadacycline vs. commonly-used antibiotic therapies
BOSTON, April 18, 2017 (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 2017, to be held April 22 – 25 in Vienna, Austria. Paratek is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry.
“We will have thirteen posters or presentations at ECCMID, which continue to demonstrate the breadth of the clinical program supporting the development of omadacycline. With these data, we continue to deepen our understanding of its utility against relevant pathogens and serious community-acquired infections such as ABSSSI and CABP,” said Evan Loh, M.D., President, Chief Operating Officer, and Chief Medical Officer, Paratek. “Notably, we will share the results from our Phase 3 once-daily oral and IV ABSSSI study, as well as the detailed analysis of microbiology results from the same study. With the growing challenge of antimicrobial resistance, additional examination of these data further reinforces the potential of omadacycline, particularly when resistance is of concern.”
Paratek’s Phase 3 study in ABSSSI is known as OASIS (Omadacycline Acute Skin and Skin Structure Infections Study).
Paratek Presentations on Monday, April 24, 2017 at 11:30 a.m. – 12:30 p.m. CEST (5:30 a.m. ET)
Oral Session: New agents for bacterial infection in phase 2 and 3 clinical trials
A phase 3 randomized, double-blind, multi-centre study to compare the safety and efficacy of oral and IV omadacycline to linezolid for treating adult subjects with ABSSSI (the OASIS study)
Abstract #: 630; Presenter: E. Loh
Paratek Presentations on Monday, April 24, 2017 at 12:30 – 1:30 p.m. CEST (6:30 a.m. ET)
Poster Session: New data on new tetracyclines
Efficacy of oral and IV omadacycline vs. linezolid for treating adult subjects with ABSSSI: analysis by infection type and pathogen in the OASIS study
Abstract #: 889; Presenter: W. O’Riordan
Cost-saving opportunities among hospitalized patients with acute bacterial skin and skin structure infections with omadacycline, a once-daily antibiotic with IV-to-oral transition capability, relative to current standard of inpatient care
Abstract #: 955; Presenter: T. Lodise
Economic impact of omadacycline among acute bacterial skin and skin structure infections (ABSSSIs) patients: cost-saving opportunities due to avoidable hospitalizations using an antibiotic with IV-to-oral switch capability
Abstract #: 1101; Presenter: K. LaPensee
In vitro activity of omadacycline and comparators against Gram-negative bacterial isolates collected from patients in European medical centres (2016): results from the SENTRY antimicrobial surveillance program
Abstract #: 1576; Presenter: M. Huband
In vitro extracellular and intracellular activity of omadacycline against Staphylococcus aureus
Abstract #: 1726; Presenter: J. Dubois
In vitro activity of omadacycline and comparators against Staphylococci, Streptococci and Enterococci (including resistant organism subsets) from patients in European medical centres during 2016: results from the SENTRY antimicrobial surveillance program
Abstract #: 2920; Presenter: M. Huband
The impact of non-standard test conditions on the in-vitro activity of omadacycline by broth microdilution
Abstract #: 3907; Presenter: C. Pillar
The in-vitro activity of omadacycline and comparators against anaerobic bacteria
Abstract #: 3940; Presenter: C. Pillar
Effects of IV/oral omadacycline versus IV/oral linezolid on lesion size and local signs of ABSSSI in the Phase 3 OASIS trial
Abstract #: 4089; Presenter: E. Loh
Efficacy of omadacycline versus linezolid in treating ABSSSI patients from different geographic regions (OASIS trial)
Abstract #: 4114; Presenter: E. Loh
Safety and tolerability of IV omadacycline (OMC) and tigecycline (TGC) in healthy subjects in a study to assess intra-pulmonary steady-state concentrations
Abstract #: 5737; Presenter: E. Loh
Paratek Presentations on Tue, Apr 25, 2017 at 1:30 – 3:30 p.m. CEST (7:30 a.m. ET)
Oral Session: PK/PD: what you need to learn for new and old-revived antibiotics
Comparison of omadacycline (OMC) and tigecycline (TGC) pharmacodynamics (PD) in the plasma, epithelial lining fluid (ELF), and alveolar macrophages (AM) in healthy subjects
Abstract #: 3760; Presenter: K. Rodvold
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. Paratek’s lead product candidate, omadacycline, is the first in a new class of tetracyclines known as aminomethylcyclines, with broad-spectrum activity against Gram-positive, Gram-negative and atypical bacteria. In June 2016, Paratek announced positive efficacy data in a Phase 3 registration study in acute bacterial skin and skin structure infections (ABSSSI) demonstrating the efficacy, general safety, and tolerability of intravenous (IV) to once-daily oral omadacycline compared to linezolid. In April 2017, Paratek announced positive efficacy data in a Phase 3 registration study in Community-acquired Bacterial Pneumonia (CABP) demonstrating the efficacy and safety of intravenous (IV) to once-daily oral omadacycline compared to moxifloxacin. A Phase 3 registration study in ABSSSI comparing once-daily oral-only dosing of omadacycline to twice-daily oral-only dosing of linezolid was initiated in August 2016. Top line data from this study are expected as early as the end of June 2017. A Phase 1B study in uncomplicated urinary tract infections (UTI) was initiated in May 2016 and positive top-line PK proof-of-principle data were reported in November 2016. The company plans to begin enrolling patients in a proof-of-concept Phase 2 study in complicated UTI as early as December 2017.
Omadacycline is a once-daily oral and IV, well-tolerated broad spectrum investigational antibiotic being developed for use as empiric monotherapy for patients suffering from serious community-acquired bacterial infections, such as acute bacterial skin and skin structure infections, community acquired bacterial pneumonia, urinary tract infections and other community-acquired bacterial infections, particularly when antibiotic resistance is of concern to prescribing physicians. 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.
In October 2016, Paratek announced a new cooperative research effort with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) to study omadacycline against pathogenic agents causing infectious diseases of public health and biodefense importance. These studies are designed to confirm dosing regimens and assess efficacy of omadacycline against biodefense pathogens, including Yersinia pestis (plague) and Bacillus anthracis (anthrax).
Paratek’s second Phase 3 product candidate, sarecycline, is a well-tolerated, once-daily oral, narrow spectrum tetracycline-derived antibiotic with potent anti-inflammatory properties for the potential treatment of acne and rosacea in the community setting. Allergan owns the U.S. rights for the development and commercialization of sarecycline. Paratek retains all ex-U.S. rights. In March 2017, Allergan announced positive efficacy data in two identical Phase 3 registration studies in acne vulgaris demonstrating the efficacy and safety of once-daily, oral-only sarecycline compared to placebo.
For more information, visit www.paratekpharma.com.
Forward Looking Statements
This press release contains forward-looking statements including statements related to our overall strategy, product candidates, clinical studies, prospects 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 of 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, and the prospect of omadacycline providing broad-spectrum activity. 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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