Poster Presentation: Phase 1 study assessing pharmacokinetics and safety of omadacycline in uncomplicated urinary tract infections
BOSTON, May 24, 2017 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today that data from its omadacycline clinical and microbiology programs will be presented at ASM Microbe 2017, to be held June 1 – 5 in New Orleans. Paratek is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry.
“As we advance our clinical program, we continue to be encouraged by the study outcomes that add to our breadth of knowledge about the safety and efficacy of once-daily oral and IV omadacycline in the treatment of bacterial infections,” said Evan Loh, M.D., President, Chief Operating Officer, and Chief Medical Officer, Paratek. “Results from the 10 studies being presented at ASM Microbe include new phase 1 data examining omadacycline in patients with uncomplicated urinary tract infection as well as additional analyses of microbiology data that help further our understanding of how omadacycline may be used in a clinical setting. We continue to be excited about the potential for this compound to treat severe bacterial infections, particularly when resistance is of concern.”
Paratek Presentations on Friday, June 2, 2017 at 12:45 p.m. – 2:45 p.m. CDT (1:45 p.m. – 3:45 p.m. EDT)
Poster Session 45: Infection Prevention and Control: Skin, Soft Tissue and Bone Infections
Characteristics of Hospitalized Patients with ABSSSI Treated with Vancomycin at Greatest Risk for Prolonged Hospital Length of Stay in an Integrated Delivery Network
Poster #: 239; Presenter: K. LaPensee
Patient (Pt) Populations at Greatest Risk for Hospital Readmission or Repeat Emergency Department (ED) Visit within 30 Days of Hospital Discharge among Hospitalized Pts with Acute Bacterial Skin and Skin Structure Infections (ABSSSIs) Treated with Vancomycin
Poster #: 240; Presenter: K. LaPensee
Paratek Presentations on Saturday, June 3, 2017 at 12:15 p.m. – 2:15 p.m. CDT (1:15 p.m. – 3:15 p.m. EDT)
Poster Session 185: Antibacterial Resistance: In vitro Activity and Resistance to Tigecyline, Fosfomycin and Derivatives
In Vitro Antibacterial Activity of Omadacycline and Comparators against Key Respiratory, Skin and Skin Structure and Urinary Tract Pathogens Collected from the United States and Europe During the 2016 SENTRY Worldwide Surveillance Program
Poster #: 45; Presenter: M. Huband
In Vitro Antibacterial Activity of Omadacycline, a New Aminomethylcycline, against Gram-Positive and Gram-Negative Bacterial Pathogens Isolated from Patients Attending Canadian Hospitals in 2015: The CANWARD Study
Poster #: 46; Presenter: G. Zhanel
Poster Session 192: Infection Prevention and Control: Healthcare-associated Infections and Infection Prevention
Patient (Pt) Populations at Greatest Risk for Hospital Readmission or Repeat ED Visit within 30 Days of Hospital Discharge among Hospitalized Pts with Community-Acquired Bacterial Pneumonia (CABP)
Poster #: 197; Presenter: T. Lodise
Paratek Presentations Sunday, June 4, 2017 at 12:15 p.m. – 2:15 p.m. CDT (1:15 p.m. – 3:15 p.m. EDT)
Poster Session 341: Antimicrobial Pharmacokinetics: PK/PD of New Antimicrobial Agents
Pharmacokinetics and Safety of Omadacycline in Patients with Uncomplicated Urinary Tract Infections
Poster #: 200; Presenter: J. Overcash
Pharmacokinetics and Safety of the Aminomethylcycline Antibiotic Omadacycline in Subjects with Impaired Renal Function
Poster #: 201; Presenter: E. Tzanis
Safety and Pharmacokinetic Assessments of the Antibiotic Omadacycline Administered to Healthy Subjects in Oral Multiple Dose Regimens
Poster #: 202; Presenter: E. Tzanis
Poster Session 345: Clostridium difficile: Epidemiology and Strategies for Prevention and Treatment of CD Infections
Effects of Omadacycline vs Moxifloxacin on Gut Microbiota Populations and Clostridium difficile Germination, Proliferation and Toxin Production in an In Vitro Model of the Human Gut
Poster #: 261; Presenter: M. Wilcox
Poster Session 351: New Antimicrobial Agents: New Antibacterial Agents II
A Multi Site Study Comparing a Commercially Prepared Dried MIC Susceptibility System to the CLSI Broth Microdilution Method for Omadacycline Using Non-Fastidious Gram Positive Organisms
Poster #: 331; Presenter: N. M. Holliday
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, when approved, will be the first in a new class of tetracyclines known as aminomethylcyclines, with broad-spectrum activity against Gram-positive, Gram-negative and atypical bacteria. Omadacycline is a new, once-daily oral and intravenous broad spectrum 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 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 and 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 general safety and tolerability of 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. This study completed enrollment in May 2017 and top-line data are expected in mid-July. The Company plans to submit its new drug application (NDA) in the U.S. as early as the first quarter of 2018 with an EMA submission later in 2018.
In addition to its Phase 3 program for omadacycline, a Phase 1B study in uncomplicated urinary tract infections (UTI) was initiated in May 2016 and positive top-line PK proof-of-principle data was reported in November 2016. The Company plans to begin enrolling patients in a proof-of-concept Phase 2 study of omadacycline in acute pyelonephritis, the most common subset of complicated urinary tract infections, as early as December 2017.
In October 2016, Paratek announced a research agreement with the U.S. Department of Defense to explore the utility of omadacycline against pathogenic agents causing infectious diseases of public health and biodefense importance including plague and anthrax.
In April 2017, Paratek Bermuda Ltd., a wholly-owned subsidiary of the Company, and Zai Lab (Shanghai) Co., Ltd., entered into a License and Collaboration Agreement. Under the terms of the Agreement, the Company granted Zai an exclusive license to develop, manufacture, and commercialize omadacycline in the People’s Republic of China, Hong Kong, Macau and Taiwan, for all human therapeutic and preventative uses, other than biodefense.
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. Allergan and Paratek reported positive results from two identical Phase 3 registration studies of sarecycline for the treatment of moderate to severe acne vulgaris in March 2017. Allergan has publicly announced plans to submit an NDA in the U.S. in the second half of 2017.
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, 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.
LifeSci Advisors, LLC.