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 date 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 NetworkPoster #:
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
VancomycinPoster #: 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 ProgramPoster
#: 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 StudyPoster #: 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 InfectionsPoster #:
200; Presenter: J. Overcash
Pharmacokinetics and Safety of the Aminomethylcycline Antibiotic
Omadacycline in Subjects with Impaired Renal FunctionPoster
#: 201; Presenter: E. Tzanis
Safety and Pharmacokinetic Assessments of the Antibiotic
Omadacycline Administered to Healthy Subjects in Oral Multiple Dose
RegimensPoster #: 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
GutPoster #: 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
OrganismsPoster #: 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 StatementsThis 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.
CONTACTS:
Media Relations:
Michael Lampe
(484) 575-5040
michael@scientpr.com
Investor Relations:
Hans Vitzthum
LifeSci Advisors, LLC.
212-915-2568
Paratek Pharmaceuticals (NASDAQ:PRTK)
Historical Stock Chart
From Mar 2024 to Apr 2024
Paratek Pharmaceuticals (NASDAQ:PRTK)
Historical Stock Chart
From Apr 2023 to Apr 2024