Paratek Initiates Phase 3 Study of Oral-only Omadacycline in ABSSSI
August 15 2016 - 8:00AM
Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today the
dosing of the first patient in its second pivotal Phase 3 study of
omadacycline in patients with acute bacterial skin and skin
structure infections (ABSSSI). This Phase 3 study will assess the
efficacy and safety of once-daily oral-only omadacycline compared
with twice-daily oral-only linezolid in subjects with ABSSSI.
“Oral antibiotic therapies for community-acquired skin
infection, when effective, are advantageous, because they can
eliminate the need for a hospital stay, thereby substantially
reducing the overall cost of treatment and limiting a patient’s
exposure to secondary infection in the hospital setting.
Unfortunately, resistance to the existing, older oral agents has
led to increasing hospital visits, so there is a need for a new,
effective, broad spectrum oral agent with MRSA coverage for
community-acquired skin infections,” said Evan Loh, President and
Chief Medical Officer, Paratek. “Omadacycline is an excellent
candidate for study in these infections as it is broad spectrum,
well-tolerated, and available in a once-daily oral formulation. We
look forward to building on the strength of our clinical program,
having already demonstrated robust efficacy and safety in our Phase
3 study of IV to oral omadacycline in ABSSSI, reported earlier this
year.”
The Phase 3, randomized, double-blind, multi-center study in
adults with moderate to severe ABSSSI will compare 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 60 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)Acute Bacterial Skin and Skin Structure
Infections are responsible for more than 750,000 hospitalizations
per yeari, representing a 17.3% increase in hospitalized ABSSSI
patients from 2005 to 2011.ii
About ParatekParatek 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. In June 2016
Paratek announced positive efficacy data in a Phase 3 registration
study in ABSSSI demonstrating the efficacy and safety of
omadacycline compared to linezolid. A Phase 3 registration study
for community acquired bacterial pneumonia (CABP) comparing
IV-to-oral omadacycline to IV-to-oral moxifloxacin was initiated in
November 2015. Enrollment continues on track to report top
line data as early as the third quarter of 2017. 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. Top line data are expected as early as
the second quarter of 2017. A phase 1b study in uncomplicated
urinary tract infections (UTI) was initiated in May 2016.
Enrollment is nearly complete with top line data expected as early
as the fourth quarter of 2016. 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 data are
expected in the first half of 2017.
For more information, visit www.paratekpharma.com.
Forward Looking Statement Certain
statements in this press release 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.
i LaPensee KT, Fan W, Wang Y. PIN22 Economic Burden of
Hospitalization With Antibiotic Treatment for ABSSSI in the
United States: An Analysis Of the Premier Hospital Database. Value
in Health. 2012;15(4):A240–A241.ii Kaye, Keith S., et al.
"Rising United States hospital admissions for acute bacterial skin
and skin structure infections: recent trends and economic impact."
PloS one 10.11 (2015): e0143276.
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