Paratek Pharmaceuticals Announces Positive Top-line Efficacy and Safety Data from Post-Marketing Study of NUZYRA® (omadacycline) for Patients with Moderate to Severe Community-Acquired Bacterial Pneumonia
18 Julio 2024 - 6:30AM
Paratek Pharmaceuticals, Inc., a biopharmaceutical company focused
on providing innovative medical therapies that create positive
patient stories in the hospital, community and public health
settings, today released positive top-line results from a global,
Phase 3 post-marketing commitment study comparing its once-daily
oral and IV, broad-spectrum antibiotic NUZYRA® (omadacycline) to
moxifloxacin in the treatment of patients with moderate to severe
community-acquired bacterial pneumonia (CABP).
Results from this double-blind study of moderate to
severe CABP patients (n = 670 patients; PORT Risk Class III or IV)
are consistent with findings from the pivotal Phase 3 study
“Omadacycline for Pneumonia Treatment in the Community” (OPTIC; n =
774 adults; PORT Risk II, III, IV), which supported approval of
NUZYRA for CABP by the U.S. Food and Drug Administration (FDA) and
which was published in The New England Journal of Medicine in
2019.
“This study provides additional data confirming
NUZYRA as an effective and well-tolerated treatment option for
community-acquired bacterial pneumonia, a serious respiratory
illness with significant impact to morbidity and mortality in the
United States,” said Randy Brenner, chief development and
regulatory officer of Paratek. “With the completion of this
post-marketing study, our clinical study database now includes data
from 1,438 pneumonia patients and is the largest clinical trial
dataset in pneumonia across all antibiotics approved by the FDA in
the last decade. We believe these data support a near-term
opportunity to update the current American Thoracic
Society/Infectious Diseases Society of America CAP guidelines. We
are extremely grateful to the patients, investigators, Paratek
team, and our partners for their commitment to this study. We
intend to submit the study report to the FDA and engage in label
update negotiations later this year.”
Study Design and Top-Line
FindingsThe global, Phase 3 clinical study known as
OPTIC-2 (Omadacycline for Pneumonia Treatment in the Community-2),
compared the efficacy and safety of once-daily, IV-to-oral
omadacycline to IV-to-oral moxifloxacin for treating adults with
moderate to severe CABP. In the study, 670 patients were
randomized. Omadacycline met the FDA-specified primary endpoint of
statistical non-inferiority (NI) in the intent-to-treat (ITT)
population (10% NI margin, 95% confidence interval) compared to
moxifloxacin at the early clinical response (ECR) timepoint (72-120
hours after initiation of therapy). High rates of clinical success
were observed with ECR rates of 89.6 % and 87.7%, for the
omadacycline and moxifloxacin treatment arms, respectively.
Omadacycline also met all FDA-specified secondary endpoints,
achieving non-inferiority vs moxifloxacin at the post-treatment
evaluation (PTE) visit 5-10 days after the completion of therapy in
both the ITT population (86.0% for omadacycline vs. 87.7% for
moxifloxacin) and in the clinically evaluable (CE) population
(94.1% for omadacycline vs. 95.9% for moxifloxacin) as determined
by investigators. Efficacy results were consistent across study
populations, PORT Risk Class and causative pathogen.
In the study, omadacycline was generally safe and
well-tolerated, consistent with prior studies of omadacycline and
the current FDA prescribing information for NUZYRA. The most common
treatment emergent adverse events (TEAEs) in omadacycline-treated
patients (occurring in > 2% of patients) were headache (3.6%
with omadacycline vs. 4.5% with moxifloxacin), COVID-19 (3.3% with
omadacycline vs. 1.2% with moxifloxacin) and AST increase (2.1%
with omadacycline vs. 0.0% with moxifloxacin). Gastrointestinal
adverse events of interest were rare and infrequent for
omadacycline vs. moxifloxacin and included: vomiting (0.0% vs.
0.3%), nausea (0.6% vs. 1.5%), and diarrhea (0.0% vs. 3.0%). There
were no cases of clostridium difficile colitis or infection in
either treatment group. Rates of TEAEs were 27.7% for omadacycline
vs. 23.5% for moxifloxacin. Drug-related TEAEs were 2.7% for
omadacycline vs. 6.9% for moxifloxacin. Discontinuation due to
TEAEs was uncommon, 2.7% for both omadacycline and moxifloxacin.
The overall mortality rate was 1.8 % and balanced with six deaths
in each treatment arm.
Results of this study will be submitted for
publication and for presentation at an upcoming scientific
congress.
The study has been supported in whole or part with
federal funds from the Department of Health and Human Services;
Administration for Strategic Preparedness and Response; Biomedical
Advanced Research and Development Authority (BARDA) under contract
number 75A50120C00001.
About Paratek Pharmaceuticals,
Inc. Paratek Pharmaceuticals, Inc. is a commercial-stage
biopharmaceutical company focused on providing innovative medical
therapies that create positive patient stories in the hospital,
community and public health settings.
The company's lead commercial product, NUZYRA®
(omadacycline), is a once-daily oral and intravenous antibiotic
available in the United States for the treatment of adults with
community-acquired bacterial pneumonia (CABP) and acute bacterial
skin and skin structure infections (ABSSSI). Paratek has a
collaboration agreement with Zai Lab Limited for the development
and commercialization of omadacycline in the greater China region
and retains all remaining global rights. Zai Lab received approval
of both IV and oral NUZYRA as a Category 1 innovative drug by the
National Medical Products Administration of China for the treatment
of CABP and ABSSSI in December 2021. Paratek is also conducting a
Phase 2b study with NUZYRA in a rare disease, non-tuberculous
mycobacterial (NTM) pulmonary disease, caused by Mycobacterium
abscessus complex.
In December 2019, BARDA awarded Paratek a contract
that is now valued at up to approximately $304 million. In addition
to supporting the development of NUZYRA for both the treatment and
prophylaxis of pulmonary anthrax, this contract supports the U.S.
onshoring of NUZYRA and manufacturing security requirements; FDA
post-marketing requirements associated with the initial NUZYRA
approval; and the procurement of up to 10,000 treatment courses of
NUZYRA for the treatment of anthrax.
For more information,
visit www.ParatekPharma.com or follow us
on LinkedIn and X.
About NUZYRA®NUZYRA®
(omadacycline) is a novel antibiotic with both once-daily oral and
intravenous (IV) formulations for the treatment of
community-acquired bacterial pneumonia (CABP) and acute bacterial
skin and skin structure infections (ABSSSI). A modernized
tetracycline, NUZYRA is specifically designed to overcome
tetracycline resistance and exhibits activity across a spectrum of
bacteria, including Gram-positive, Gram-negative, atypicals and
other drug-resistant strains.
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