- Microbiology analysis and full results of Phase
3 OASIS study presented at ECCMID 2017
Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today that an
analysis of microbiology data from its Phase 3 study of
omadacycline in acute skin infections found that once-daily
treatment with IV-to-oral omadacycline is effective in treating the
most frequently isolated bacterial pathogens associated with skin
infections, including methicillin-resistant Staphylococcus aureus
(MRSA). These findings were presented for the first time at the
annual meeting of the European Congress of Clinical Microbiology
and Infectious Diseases (ECCMID 2017) in Vienna, Austria.
Paratek also presented full clinical efficacy, safety and
tolerability results from the study, which is known as OASIS
(Omadacycline Acute Skin and Skin Structure Infections Study). The
full results demonstrate the efficacy and safety of omadacycline
compared to linezolid in acute bacterial skin and skin structure
infections (ABSSSI).
“With this new microbiology analysis, we further increase the
body of evidence regarding the utility of omadacycline against
serious community-acquired infections and pathogens with known
resistance patterns, including MRSA,” said Evan Loh, M.D.,
President, Chief Operating Officer and Chief Medical Officer,
Paratek. “These results, coupled with the recently announced
positive topline results of our Phase 3 registration study in
community-acquired bacterial pneumonia, continue to bolster our
confidence in omadacycline and its potential to address the
significant health challenge of antibiotic resistance.”
Analyses by Infection Type and Pathogen in the OASIS
StudyOASIS was a global Phase 3 randomized, double-blind,
multi-center study comparing the safety and efficacy of IV-to-oral
once-daily omadacycline with twice-daily linezolid over a
7-to-14-day course of therapy in 645 treated adult patients with
ABSSSI. To analyze clinical success per infection type, the
modified intent-to-treat (mITT) population included randomized
subjects without a sole Gram-negative pathogen at screening
(n=627). Among this population, infection type broke down as
follows: 33% wound infection; 38% cellulitis/erysipelas; and 29%
major abscess. At Post Therapy Evaluation (PTE, 7 – 14 days after
the last day of treatment), once-daily omadacycline was effective
across all infection types studied. Compared to twice-daily
linezolid, efficacy for once-daily omadacycline was comparable in
wound infection (81% vs 81%), cellulitis/erysipelas (91% vs 85%),
and major abscess (85% vs 85%).
Further analysis of the micro-mITT population, which included
patients with at least one Gram-positive pathogen at screening
(n=455), showed that the most common pathogen was Staphylococcus
aureus (68% overall, 61% MSSA and 39% MRSA) followed by
Streptococcus anginosus (19%) with mixed Gram-positive and
Gram-negative infections in 15% of the patients. Overall clinical
success at PTE in this group was 83% for omadacycline vs 83% for
linezolid (MSSA 84% vs 82%; MRSA 83% vs 86%, S. anginosus 75% vs
70%, mixed infections 81% vs 76%).
OASIS Full ResultsThe full results of OASIS
presented today at ECCMID expanded on the positive topline results
first announced in June 2016. Omadacycline met the U.S. Food and
Drug Administration-specified primary efficacy endpoint of early
clinical response (ECR) and the two European Medicines
Agency-specified co-primary efficacy endpoints for post-treatment
evaluation (PTE). In the study, the ECR in the modified Intent
to Treat (mITT) population for the omadacycline and linezolid
treatment arms was 84.8% compared to 85.5%, respectively.
At PTE in the mITT and the clinically evaluable (CE)
populations, omadacycline achieved the primary efficacy endpoint of
statistical non-inferiority (10% margin) compared to linezolid. In
the mITT population at PTE, clinical success rates for the
omadacycline and linezolid treatment arms were 86.1% and 83.6%,
respectively. In the CE population at PTE, clinical success rates
for the omadacycline and linezolid treatment arms were 96.3% and
93.5%, respectively.
Additional OASIS Sub-Analyses Expands Body of Evidence
for OmadacyclineAdditional presentations at ECCMID
highlighted the efficacy of omadacycline in ABSSSI across
geographic regions and demonstrated that omadacycline reduces skin
lesion size and local signs of ABSSSI.
- Regional distribution of infection type remained consistent
across OASIS study locations in North America, Latin America,
Eastern Europe and Western Europe, with aureus emerging as the most
prevalent. Clinical success at PTE among the mITT population
(n=627) for omadacycline vs linezolid was 80.7% vs 80.2% in North
America; 100% vs 94% in Eastern Europe and 82.6% vs 76.2% in
Western Europe; Latin America was not included in the evaluation
because of a limited sample size (< 5 subjects per treatment
group).
- Further analysis of OASIS demonstrated treatment of ABSSSI with
omadacycline or linezolid led to similar and rapid reductions in
lesion size and local signs of infection. In the mITT population,
median baseline lesion area was 299.5 cm2 (OMC) and 315.0 cm2 (LZD)
at initial evaluation. Infection presence and severity was similar
for both treatment groups at baseline. Reduction in lesion area of
> 50% was seen on day two for both omadacycline and
linezolid-treated patients (14% vs 11%). A 99% reduction was
reported for both therapies at PTE.
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 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, is 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, 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, 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. Top-line data from this study are expected as early
as the end of June. 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.
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 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 of 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 Feb 2024 to Mar 2024
Paratek Pharmaceuticals (NASDAQ:PRTK)
Historical Stock Chart
From Mar 2023 to Mar 2024