Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK), a biopharmaceutical
company focused on the development and commercialization of
innovative therapies based upon tetracycline chemistry, announced
today that it has completed enrollment in its pivotal Phase 3
clinical study evaluating oral-only omadacycline for the treatment
of Acute Bacterial Skin and Skin Structure Infections (ABSSSI). The
Company expects to report top-line data from this study in
mid-July. This study is designed to assess the efficacy and safety
of once-daily oral-only omadacycline compared with twice-daily
oral-only linezolid in subjects with ABSSSI.
“The completion of enrollment of our Phase 3 oral-only study is
another important milestone for Paratek and moves us closer to
providing a new, well-tolerated, broad-spectrum once-daily
oral-only antibiotic to treat serious community-acquired skin
infections,” said Evan Loh, M.D., President, Chief Operating
Officer, and Chief Medical Officer, Paratek. “Oral antibiotic
therapies for community-acquired skin infection are advantageous as
they can eliminate the need for hospital stays, have the potential
to reduce the overall cost of treatment and limit a patient’s
exposure to secondary infection in the hospital setting.
Unfortunately, what we are seeing is that more and more people are
being admitted to the hospital for skin infections that are
resistant to the existing, older oral agents, which underscores the
need for a new, effective, broad spectrum oral agent with MRSA
coverage for community-acquired skin infections.”
The Phase 3, randomized, double-blind, multi-center study in
adults with moderate to severe ABSSSI compared the safety and
efficacy of once-daily oral omadacycline to twice-daily oral
linezolid. The study is designed to enroll approximately 700
patients at approximately 50 U.S. centers. For the purposes of
regulatory filings in the United States, the primary efficacy
endpoint defined in the protocol is the number of subjects with
clinical success at the early clinical response assessment 48-72
hours after the first dose of study drug. For regulatory filings in
the European Union, the primary endpoint will be clinical
response at the post therapy evaluation, also known as ‘test of
cure’. Other efficacy outcome measurements include
investigator assessment of clinical response, overall survival and
resolution or improvement of signs and symptoms at the
post-treatment evaluation visit (7-14 days after the last day of
therapy). In addition, safety and tolerability as assessed by
treatment-emergent adverse events, vital sign measurements, ECGs,
and laboratory values will be assessed.
About Acute Bacterial Skin and Skin Structure Infections
(ABSSSIs)ABSSSI is responsible for more than 750,000
hospitalizations per year (latest data available, 2011),
representing a 17.3% increase in hospitalized ABSSSI patients from
2005 to 2011.
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. Zai will
be responsible for the development, manufacturing and
commercialization of the licensed product in the licensed
territory, at its sole cost with certain assistance from the
Company.
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
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