– Biofilm, post-antibiotic effects, microbiologic surveillance and omadacycline in vitro activity against
select pathogens to be presented
– Clinical PK and Modelling Strategies for omadacycline to be presented
BOSTON, June 13, 2016 (GLOBE NEWSWIRE) — Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today that data from its omadacycline microbiology and clinical programs will be presented at the American Society of Microbiology’s annual meeting, ASM Microbe 2016, to be held June 16 – 20, 2016 in Boston, Mass. Additional poster presentations conducted by external parties will also be presented at the conference. Paratek is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry.
“The nine posters that will be presented at ASM Microbe broaden our understanding of the potential utility of omadacycline against a range of clinically relevant pathogens, and demonstrate the dosing flexibility with our once-daily oral formulation,” said Evan Loh, M.D., President and Chief Medical Officer of Paratek. “We continue to build on the breadth of important clinical data for omadacycline, and we look forward to sharing the top line data from our Phase 3 registration study in ABSSSI before the end of this month.”
Paratek Presentations:
in Vitro Protein Binding With Omadacycline, A First In Class Aminomethylcycline Antibiotic
Abstract #: MONDAY-518
Presenter: S. A. Villano
Session: 421 – Pharmacokinetic/Pharmacodynamic (PK/PD) of New Drugs
Date and Time: Monday, June 20, 2016 at 12:30 p.m.Effect Of Food On The Bioavailability Of Omadacycline In Healthy Volunteers
Abstract #: MONDAY-519
Presenter: E. Tzanis
Session: 421 – Pharmacokinetic/Pharmacodynamic (PK/PD) of New Drugs
Date and Time: Monday, June 20, 2016 at 12:30 p.m.
External Presentations:
Activity of Omadacycline against Clinical Isolates of Neisseria gonorrhoeae, Including Ciprofloxacin-Resistant Isolates
Abstract #: MONDAY-001
Presenter: C. Pillar
Session: 394 – Antimicrobial Susceptibility Testing of Newer and ReNewed Antimicrobial Agents
Date and Time: Monday, June 20, 2016 at 12:30 p.m.Population Pharmacokinetics (PPK) of Omadacycline (OMC) Following Intravenous (IV) or Oral Administration and Evaluation of Phase 3 Sparse PK Sampling Strategies
Abstract #: MONDAY-509
Presenter: S. A. VanWart
Session: 421 – Pharmacokinetic/Pharmacodynamic (PK/PD) of New Drugs
Date and Time: Monday, June 20, 2016 at 12:30 p.m.Evaluation of the In Vitro Activity Profile of Omadacycline against Haemophilus influenzae
Abstract #: MONDAY-510
Presenter: B. D. VanScoy
Session: 421 – Pharmacokinetic/Pharmacodynamic (PK/PD) of New Drugs
Date and Time: Monday, June 20, 2016 at 12:30 p.m.Post Antibiotic Effect of Omadacycline against Target Pathogens
Abstract #: MONDAY-512
Presenter: C. Pillar
Session: 421 – Pharmacokinetic/Pharmacodynamic (PK/PD) of New Drugs
Date and Time: Monday, June 20, 2016 at 12:30 p.m.in Vitro Intracellular Activity of Omadacycline against Legionella pneumophila
Abstract #: MONDAY-551
Presenter: J. Dubois
Session: 424 – Tetracyclines, Aminoglycosides, and Related Compounds
Date and Time: Monday, June 20, 2016 at 12:30 p.m.in Vitro Activity of Omadacycline against E. coli Biofilms
Abstract #: MONDAY-552
Presenter: N. Bionda
Session: 424 – Tetracyclines, Aminoglycosides, and Related Compounds
Date and Time: Monday, June 20, 2016 at 12:30 p.m.Omadacycline (PTK0796) Spectrum of Activity from 2003-2015
Abstract #: MONDAY-567
Presenter: M. M. Traczewski
Session: 424 – Tetracyclines, Aminoglycosides, and Related Compounds
Date and Time: Monday, June 20, 2016 at 12:30 p.m.
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. Paratek completed enrollment in a Phase 3 registration study in ABSSSI in March 2016 to determine the efficacy and safety of omadacycline compared to linezolid. Top-line data from this study is expected to be available as early as the end of June 2016. A Phase 3 registration study for CABP comparing omadacycline to moxifloxacin was initiated in November 2015 and top-line data is expected as early as the third quarter of 2017. Paratek initiated a Phase 1b study of omadacycline in urinary tract infections in May 2016. Omadacycline has been granted Fast Track status by the U.S. Food and Drug Administration.
Omadacycline is a new once-daily oral and IV, well-tolerated 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, complicated urinary tract infections (cUTI), and other community-acquired bacterial infections, particularly when antibiotic resistance is of concern to prescribing physicians.
Paratek’s second Phase 3 product candidate, sarecycline, is a new once-daily oral tetracycline-derived compound for the potential treatment of acne and rosacea in the community setting. Sarecycline is designed to be a well-tolerated, once-daily oral, narrow spectrum antibiotic with anti-inflammatory properties. Allergan owns the U.S. rights for the development and commercialization of sarecycline. Paratek retains all ex-U.S. rights. Allergan initiated two identical Phase 3 registration studies in December 2014 for sarecycline for the treatment of moderate to severe acne vulgaris. Top line data is expected from these studies in the second half of 2016.
For more information, visit www.paratekpharma.com. The information contained on, or that may be accessed through, Paratek’s website is not incorporated by reference into, and is not a part of, this document.
Forward Looking Statement
Certain statements in this press release, including Paratek’s statements regarding the projected availability of top-line data from the Phase 3 clinical trials of omadacycline and sarecycline are forward-looking statements. These forward-looking statements are based upon Paratek’s current expectations and involve substantial risks and uncertainties. These risks and uncertainties include, but are not limited to: (i) unexpected results may cause the designs of the clinical trials to change, or the projected timelines of the trials to be extended, (ii) unexpected decline in the rates of patient enrollment in the clinical trials, (iii) unforeseen adverse effects experienced by patients resulting in a clinical hold, (iv) failure of patients to complete clinical trials, (v) risks related to regulatory oversight of the trials, (vi) the need for substantial additional funding to complete the development and commercialization of product candidates and (vii) risks that data to date and trends may not be predictive of future results. These and other risk factors are discussed under “Risk Factors” and elsewhere in Paratek’s Annual Report on Form 10-K for the year ended December31, 2015 and Paratek’s other filings with the Securities and Exchange Commission. Paratek expressly disclaims any obligation or undertaking to update or revise any forward-looking statements contained herein.
CONTACT: CONTACTS: Media Relations: Michael Lampe (484) 575-5040 [email protected] Investor Relations: Hans Vitzthum LifeSci Advisors, LLC. 212-915-2568