Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today
positive top-line results from a pivotal Phase 3 clinical study
comparing its once-daily, oral investigational antibiotic,
omadacycline, to twice-daily oral linezolid in the treatment of
acute bacterial skin and skin structure infections (ABSSSI). The
study met all of its primary and secondary endpoints required to
support approval for this indication by the U.S. Food and Drug
Administration (FDA) and the European Medicines Agency (EMA). This
represents the third positive Phase 3 registration study of
omadacycline.
“This successful study demonstrates the potential of an
oral-only dosing regimen of omadacycline, which would enable
treatment in the outpatient setting and potentially reduce the need
for admission to the hospital,” said Michael Bigham, Chairman and
Chief Executive Officer of Paratek. “The utility of the oral only
dosing regimen represents a significant potential benefit to
patients and prescribers who are in need of new, effective oral
agents to combat serious community-acquired infections.”
The pivotal Phase 3 clinical study known as OASIS-2
(Omadacycline in Acute Skin Structure Infections Study) evaluated
the efficacy and safety of once-daily, oral-only omadacycline
compared to twice-daily, oral-only linezolid in 735 adults with
ABSSSI. Omadacycline met the FDA-specified primary endpoint of
statistical non-inferiority (NI) in the modified intent-to-treat
(mITT) population (10% NI margin, 95% confidence interval) compared
to linezolid at the early clinical response (ECR), 48 to 72 hours
after the first dose of study drug. The ECR rate for omadacycline
was 87.5% compared to 82.5% for linezolid.
Additionally, omadacycline met statistical NI compared to
linezolid for the EMA-specified co-primary endpoints at the post
therapy evaluation (PTE), 7 to 14 days after completion of therapy
in the mITT and the Clinically Evaluable (CE) populations. Clinical
success rates at PTE in the mITT population for the omadacycline
and linezolid arms were 84.2% vs. 80.8%, respectively; and in the
CE population were 97.9% vs. 95.5%, respectively.
Omadacycline demonstrated high clinical success rates for
infections caused by the most common ABSSSI pathogens, including
methicillin-resistant Staphylococcus aureus (MRSA).
In the OASIS-2 study, there was a low rate of study treatment
discontinuation for both omadacycline and linezolid patients at
10.9% vs. 14.2%, respectively. Less than 2% of patients
discontinued treatment due to adverse events in both treatment
groups. No deaths occurred in the omadacycline treatment arm. The
most common treatment emergent adverse events (TEAEs) in
omadacycline and linezolid treated patients were nausea (30.2% vs.
7.6%, respectively) and vomiting (16.8% vs. 3.0%, respectively).
Seventy-five percent of the nausea was classified as mild with none
reported as severe, and only one omadacycline patient discontinued
treatment for gastrointestinal events. The vast majority of the
onset of the nausea or vomiting in omadacycline patients occurred
during the loading-dose phase on day 1 or day 2, and the median
duration of these episodes was two days. Additional TEAEs,
occurring in ≥ 3% of omadacycline patients were increased alanine
aminotransferase (ALT; 5.2%), increased aspartate aminotransferase
(AST; 4.6%), diarrhea (4.1%) and headache (3.5%), which were
generally comparable between treatment arms. No subject in either
treatment group developed Clostridium difficile
infection.
“We are excited by the outstanding efficacy observed in our
oral-only skin study, which is consistent with the efficacy we have
observed in the OASIS-1 and OPTIC studies,” said Evan Loh, M.D.,
President, Chief Operating Officer and Chief Medical Officer of
Paratek. “The gastrointestinal adverse event rates were higher in
this study than in OASIS-1; however, these events were generally
mild and transient. The completion and efficacy rates were very
high in this study, confirming the utility of the oral-only
omadacycline regimen and our confidence in the approvability of
omadacycline for ABSSSI and CABP.”
The results of this study, including the results of the
secondary endpoints, will be presented at an upcoming scientific
congress.
Conference Call and WebcastThe Company will
host a webcast and conference call for investors at 4:30 p.m. ET
today. The live webcast can be accessed under “Events and
Presentations” in the Investor Relations section of Paratek’s
website at www.paratekpharma.com. The webcast can also be accessed
at this link http://public.viavid.com/index.php?id=125259. The
webcast will be available for one year.
Domestic callers wishing to participate in the call should dial
877-407-0792 and international callers should dial 201-689-8263.
Replays of the call will be available until July 31, 2017.
Using the same conference ID, replays can be accessed by domestic
callers by dialing 844-512-2921. International callers should dial
412-317-6671. The replay PIN is 13665829.
About the OASIS-2 Study DesignThe OASIS-2 study
was a randomized, double-blind, multi-center study that enrolled
735 adult subjects with moderate to severe ABSSSI at 33 centers in
the U.S. Patients received either once daily omadacycline or twice
daily linezolid for 7-14 days. In addition to evaluating
omadacycline against the FDA- and EMA-specified primary endpoints,
the study comprised other efficacy outcome measurements including
overall survival and resolution or improvement of signs and
symptoms. In addition, safety and tolerability were assessed by
treatment-emergent adverse events, vital sign measurements, ECGs
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
product candidate, omadacycline, if 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 (OASIS-1) 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 (OPTIC)
demonstrating the efficacy and general safety and tolerability of
IV to once-daily oral omadacycline compared to moxifloxacin. The
Company plans to submit its NDAs 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, in November
2016 Paratek reported positive top-line PK proof-of-principle in a
Phase 1B study in uncomplicated urinary tract infections (UTI). The
Company plans to begin enrolling patients in a proof-of-concept
Phase 2 study of omadacycline in UTI 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
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