VIENNA, Austria, April 25, 2017 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) today presented new abstracts from a Phase 1 abstraction acknowledging that its once-daily articulate and IV, ample spectrum investigational antibacterial omadacycline finer penetrates lung tissue and epithelial lining aqueous and has a ample antimicrobial action adjoin those bacilli best frequently associated with community-acquired bacterial pneumonia (CABP). Abstracts from a additional Phase 1 abstraction evaluating the assurance of omadacycline compared to tigecycline appear no austere adverse contest afterward IV analysis with either admixture and appear that omadacycline was associated with a lower accident of gastrointestinal adverse contest compared to tigecycline. The new allegation were presented at the anniversary affair of the European Congress of Analytic Microbiology and Communicable Diseases (ECCMID 2017) in Vienna, Austria.
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“Intravenous dosing of omadacycline at 100 mg produced steady-state concentrations in the plasma, epithelial lining aqueous (ELF), and alveolar beef (AC) that were three-fold college than tigecycline in advantageous subjects. Our empiric lung concentrations forth with the minimum inhibitory absorption ethics for respiratory bacilli abutment the contempo after-effects of omadacycline actuality as able as moxifloxacin in the analysis of patients with community-acquired bacterial pneumonia,” said Keith Rodvold, Pharm.D., assistant in the College of Pharmacy, Co-Director of the Section of Communicable Diseases Pharmacotherapy at University of Illinois at Chicago.
“Throughout our analytic development program, we accept formed to accomplish a absolute compassionate of all aspects of omadacycline and allotment that advice with the accurate and analytic community,” said Evan Loh, M.D., President, Chief Operating Officer and Chief Medical Officer, Paratek. “These abstracts add to the growing anatomy of affirmation to abutment omadacycline as an able abettor in the analysis of austere acquired bacterial infections, decidedly area attrition is of affair to prescribing physicians.”
Phase 1 Bronchoalveolar Lavage StudyThe Phase 1 PK/PD abstraction compared consecutive claret concentrations of omadacycline and tigecycline in advantageous adults. Capacity accepting omadacycline (n=41) accustomed 100 mg IV every 12 hours for 2 doses again 100 mg IV once-daily; capacity in the tigecycline arm (n=17) accustomed a 100 mg IV loading dosage followed by 50 mg IV every 12 hours. To appraise the absorption of both omadacycline and tigecycline in epithelial lining aqueous (ELF) and alveolar macrophages (AM), bronchoalveolar lavage (BAL) was performed on all subjects.
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The AUC0-24/MIC90 ratios for omadacycline were greater than tigecycline beyond all measurements. Specific after-effects showed omadacycline claret ratios to be 3.2-fold college (97.8 vs. 30.8) for S. pneumoniae and MSSA and 1.5-fold college (46.9 vs. 30.8) for MRSA. The AUC0-24/MIC90 ratios in the ELF were 2.7-fold college for omadacycline (143.6 vs. 52.7) for S. pneumoniae and MSSA and 1.3-fold college (68.9 vs. 52. 7) for MRSA. AM ratios for L. pneumophila were 126-fold college for omadacycline.
Phase 1 Assurance and Tolerability StudyIn an open-label assurance abstraction presented yesterday, 63 advantageous adults were randomized to omadacycline (n=42) or tigecycline (n=21). Dosing was agnate to the PK/PD abstraction and analysis continuance was four canicule with a chase up appraisal conducted 7 to 14 canicule afterwards the final dose. Analysis appearing adverse contest were mild-to-moderate in both groups and included headache, nosebleed (epistaxis), nausea, decreased appetence and vomiting. Fewer individuals in the omadacycline accumulation appear gastrointestinal adverse event. There were two discontinuations in the tigecycline accumulation due to abhorrence that were advised accompanying to abstraction drug. No omadacycline capacity discontinued abstraction analysis due to adverse events.
About Paratek Pharmaceuticals, Inc.Paratek Pharmaceuticals, Inc. is a biopharmaceutical aggregation focused on the development and commercialization of avant-garde therapies based aloft its adeptness in aberant tetracycline chemistry. Paratek's advance artefact candidate, omadacycline, is the aboriginal in a new chic of tetracyclines accepted as aminomethylcyclines, with broad-spectrum action adjoin Gram-positive, Gram-negative and aberant bacteria. Omadacycline is a new, once-daily articulate and intravenous ample spectrum antibacterial actuality developed for use as empiric monotherapy for patients adversity from austere community-acquired bacterial infections, such as astute bacterial bark and bark anatomy infections, community-acquired bacterial pneumonia, urinary tract infections, and added community-acquired bacterial infections, decidedly back antibacterial attrition is of affair to prescribing physicians. Omadacycline has been accepted Qualified Communicable Disease Artefact appellation and Fast Track cachet by the U.S. Food and Biologic Administration for the ambition indications.
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In June 2016, Paratek appear absolute adeptness abstracts in a Phase 3 allotment abstraction in astute bacterial bark and bark anatomy infections (ABSSSI) demonstrating the efficacy, accepted assurance and tolerability of intravenous (IV) to once-daily articulate omadacycline compared to linezolid. In April 2017, Paratek appear absolute adeptness abstracts in a Phase 3 allotment abstraction in community-acquired bacterial pneumonia (CABP) demonstrating the efficacy, accepted assurance and tolerability of IV to once-daily articulate omadacycline compared to moxifloxacin. A Phase 3 allotment abstraction in ABSSSI comparing once-daily oral-only dosing of omadacycline to twice-daily oral-only dosing of linezolid was accomplished in August 2016. Top-line abstracts from this abstraction are accepted as aboriginal as the end of June. The Aggregation affairs to abide its new biologic appliance (NDA) in the U.S. as aboriginal as the aboriginal division of 2018 with an EMA acquiescence after in 2018.
In accession to its Phase 3 affairs for omadacycline, a Phase 1B abstraction in apprehensible urinary amplitude infections (UTI) was accomplished in May 2016 and absolute top-line PK proof-of-principle abstracts was appear in November 2016. The Aggregation affairs to activate enrolling patients in a proof-of-concept Phase 2 abstraction of omadacycline in astute pyelonephritis, the best accepted subset of complicated urinary amplitude infections, as aboriginal as December 2017.
In October 2016, Paratek appear a analysis acceding with the U.S. Department of Defense to analyze the account of omadacycline adjoin pathogenic agents causing communicable diseases of accessible bloom and biodefense accent including affliction and anthrax.
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Paratek's additional Phase 3 artefact candidate, sarecycline, is a well-tolerated, once-daily oral, attenuated spectrum tetracycline-derived antibacterial with almighty anti-inflammatory backdrop for the abeyant analysis of abscess and rosacea in the association setting. Allergan owns the U.S. rights for the development and commercialization of sarecycline. Paratek retains all ex-U.S. rights. Allergan and Paratek appear absolute after-effects from two identical Phase 3 allotment studies of sarecycline for the analysis of abstinent to astringent abscess vulgaris in March 2017. Allergan has about appear affairs to abide an NDA in the U.S. in the additional bisected of 2017.
Forward Looking StatementsThis columnist absolution contains advanced statements including statements accompanying to our all-embracing strategy, artefact candidates, analytic studies, affairs and accepted results, including statements about the timing of advancing omadacycline and contrarily advancing for analytic studies, the timing of acceptance in our analytic studies and of our advertisement of the after-effects of such studies, the abeyant for omadacycline to serve as an empiric monotherapy analysis advantage for patients adversity from ABSSSI, CABP, UTI, and added bacterial infections back attrition is of concern, the anticipation of omadacycline accouterment broad-spectrum activity, and our adeptness to access authoritative approval of omadacycline. All statements, added than statements of absolute facts, included in this columnist absolution are advanced statements, and are articular by words such as "advancing," "believe," "expect," "well positioned," "look forward," "anticipated," "continued," and added words and agreement of agnate meaning. These advanced statements are based aloft our accepted expectations and absorb abundant risks and uncertainties. We may not absolutely accomplish the plans, backpack out the intentions or accommodated the expectations or projections appear in our advanced statements and you should not abode disproportionate assurance on these advanced statements. Our absolute after-effects and the timing of contest could alter materially from those included in such advanced statements as a aftereffect of these risks and uncertainties. These and added accident factors are discussed beneath "Risk Factors" and abroad in our Anniversary Report on Form 10-K for the year concluded December 31, 2016, and our added filings with the Securities and Exchange Commission. We especially abandon any obligation or adventure to amend or alter any advanced statements independent herein.
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