Paratek Announces Completion of Enrollment in Omadacycline Phase 3 Community-Acquired Bacterial Pneumonia Study
January 18 2017 - 7:00AM
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 the pivotal Phase 3
clinical study evaluating omadacycline for the treatment of
Community Acquired Bacterial Pneumonia (CABP). This study, which is
designed to assess the efficacy and safety of intravenous (IV) to
once-daily oral omadacycline compared with moxifloxacin in subjects
with CABP, enrolled its first patient in November 2015. The company
expects to report top-line data from this study in the second
quarter of 2017.
“The completion of enrollment for our second Phase 3 study
represents another significant milestone for Paratek. Achieving
this milestone in our CABP study positions Paratek to submit a new
drug application as early as the first half of 2018,” said Evan
Loh, M.D., President, Chief Operating Officer, and Chief Medical
Officer, Paratek. “We are appreciative of the efforts of the
clinical investigators, grateful to the patients who participated
in this study, and very pleased with the performance of the Paratek
Clinical Development organization that has enabled enrollment in
this study to complete ahead of projections. We look forward to
sharing the topline results from this study in the coming
months.”
This Phase 3, randomized, double-blind, multi-center study is
designed to compare the safety and efficacy of IV to once-daily
oral (PO) omadacycline therapy to moxifloxacin IV/PO for treating
adults with CABP. This study planned to enroll approximately 750
adult subjects at approximately 120 centers worldwide. The study
was designed to satisfy both FDA and EMA requirements. The primary
efficacy endpoint for FDA evaluation as defined in the protocol is
the number of subjects with clinical success at the early clinical
response assessment visit 72-120 hours after the first dose of
study drug. The EMA Co-Primary Endpoints are the Investigator’s
Assessment of Clinical Response 5-10 days after the completion of
treatment for the Intent to Treat (ITT) and Clinically Evaluable
(CE) populations. Other efficacy outcome measurements include
overall survival and resolution or improvement of signs and
symptoms at the post treatment evaluation visit. Safety and
tolerability are being assessed by treatment-emergent adverse
events, vital sign measurements, electrocardiograms, and laboratory
values.
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
Phase 3 product candidate, omadacycline, is the first in a new
class of tetracyclines known as aminomethylcyclines, with
broad-spectrum activity against Gram-positive, Gram-negative,
atypical and anaerobic bacteria. In addition to the Phase 3 study
in CABP, the Phase 3 program for omadacycline includes two other
studies: 1) 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
safety of intravenous to once-daily oral omadacycline compared to
IV/PO linezolid; 2) A second Phase 3 registration study in ABSSSI
comparing once-daily oral-only dosing of omadacycline to
twice-daily oral-only dosing of linezolid (enrollment initiated in
August 2016). Top line data from this oral-only phase 3
registration ABSSSI study are expected as early as the second
quarter of 2017. A Phase 1B study in uncomplicated urinary tract
infections (UTI) reported positive top-line PK proof-of-principle
data in November 2016. In October 2016, Paratek announced a
research agreement with the U.S. Department of Defense to explore
the utility of omadacycline against pathogenic agents including
plague and anthrax. Omadacycline has been granted Qualified
Infectious Disease Product designation and 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,
urinary tract infections 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
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 initiated two identical Phase 3
registration studies in December 2014 for sarecycline for the
treatment of moderate to severe acne vulgaris. Top line Phase 3
data are expected in early 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 trials, cash
resources, prospects and expected results, including statements
about the timing of advancing omadacycline and otherwise preparing
for clinical trials, 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 having the resources to execute on
our clinical trials. 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, which include, without limitation, risks related to
(i) our need for substantial additional funding to complete the
development and commercialization of our product candidates, (ii)
our ability to raise the capital to do so, (iii) our ability to
develop our drug candidates for potential commercialization, (iv)
the advancement of omadacycline Phase 3 trials for ABSSSI and CABP,
(v) the potential for omadacycline to be successfully developed as
an empiric monotherapy for patients suffering from serious
community-acquired bacterial infections, (vi) the potential of
omadacycline to become a primary antibiotic choice of physicians
for the treatment of serious community-acquired bacterial
infections, (vii) the ability of our supply chain to provide
adequate supply to satisfy our clinical and commercial demand
(viii) the potential use and effectiveness of sarecycline for the
treatment of acne and rosacea in the community setting, and (ix)
the timing of the Phase 3 program in moderate-severe acne for
sarecycline, risks that data to date and trends may not be
predictive of future results, risks related to the conduct of our
clinical trials, and risks that our clinical trials and product
candidates do not receive regulatory approval. 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, 2015,
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:
Michael Lampe
Scient Public Relations
(484) 575-5040
michael@scientpr.com
Investors:
Hans Vitzthum
LifeSci Advisors, LLC.
212-915-2568
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