Phase 3 Optic Study Microbiology Data Demonstrate Omadacycline has Potent In vitro Activity Against Multiple Pneumonia Pathog...
06 October 2017 - 11:01PM
New microbiology data from Paratek Pharmaceuticals (Nasdaq:PRTK)
show that its well-tolerated, once-daily, oral and IV,
broad-spectrum investigational antibiotic, omadacycline, is active
against the clinically important typical and atypical
community-acquired bacterial pneumonia (CABP) pathogens. The
microbiological data from the Phase 3 OPTIC (Omadacycline
for Pneumonia Treatment in the Community)
study, which will be presented tomorrow at IDWeek 2017, demonstrate
the in vitro antibacterial activity and clinical efficacy against
gram-positive and gram-negative bacterial isolates. Paratek is a
biopharmaceutical company focused on the development and
commercialization of innovative therapies based upon tetracycline
chemistry.
In the analyses, pathogens were identified at screening through
blood culture, lower respiratory tract culture, urinary antigen for
Legionella pneumophila or Streptococcus pneumoniae, or positive
serology titers for L. pneumophila, Mycoplasma pneumoniae or
Chlamydophila pneumoniae. The most frequent pathogen isolates were:
S. pneumoniae (13.5%), H. influenzae (12.2%), H. parainfluenzae
(8.3%), Klebsiella pneumoniae (6.5%) and S. aureus (5.7%).
Omadacycline showed potent in vitro activity across all
isolates.
Overall, in the OPTIC study, monotherapy with IV to once-daily
oral omadacycline was effective in adult CABP patients with the
most frequently isolated pathogens, including multi-drug resistant
S. pneumoniae.
“These microbiology data add to our growing understanding of the
clinical and in vitro activity of omadacycline, and lay a
foundation for clinicians for its potential use in the CABP setting
where microbiological confirmation of infection is difficult and a
pathogen is only identified in less than 10 percent of patients,”
said Evan Loh, M.D., President, Chief Operating Officer, and Chief
Medical Officer, Paratek. “The potent activity observed in the
microbiology study supports previously reported in vitro data
demonstrating that omadacycline is broadly active against multiple
CABP pathogens, including resistant pathogens.”
Top-Line OPTIC Study Results The global,
pivotal Phase 3 OPTIC study compared the safety and efficacy of
once-daily, IV-to-oral omadacycline to IV-to-oral moxifloxacin for
treating adults with CABP. In the study, 774 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) 72-120 hours
after initiation of therapy. The ECR rates for the omadacycline and
moxifloxacin treatment arms were 81.1 % and 82.7%,
respectively.
Additionally, the FDA-specified secondary endpoint was the
investigator assessment of response at the post treatment
evaluation (PTE) visit (5-10 days after the completion of therapy)
in both the ITT population (87.6% for omadacycline vs. 85.1% for
moxifloxacin) and in the clinically evaluable (CE) population
(92.9% for omadacycline vs. 90.4% for moxifloxacin). Rates of
treatment emergent adverse events (TEAEs) were 41.1% for
omadacycline vs. 48.5% for moxifloxacin.
Serious TEAEs were reported in 6.0% of omadacycline patients
compared to 6.7% of moxifloxacin, and discontinuation due to TEAEs
was uncommon (5.5% for omadacycline vs. 7.0% for moxifloxacin).
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. The
Company’s lead product candidate, omadacycline, is a new,
once-daily oral and intravenous broad-spectrum antibiotic being
developed for the treatment of serious community-acquired bacterial
infections, including community-acquired bacterial pneumonia
(CABP), acute bacterial skin and skin structure infections
(ABSSSI), and urinary tract infections. 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 of ABSSSI, CABP,
uUTI and cUTI. Paratek has completed Phase 3 development activities
for omadacycline in CABP and ABSSSI and is preparing to submit
marketing applications in the United States and European
Union. Paratek has licensed rights for omadacycline to Zai
Lab for the greater China region, and retains all
remaining global rights. Under a research agreement with
the U.S. Department of Defense, omadacycline also is being
studied 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 being developed by Allergan in the U.S. as a new
once-daily oral therapy for the treatment of acne. Allergan
has completed Phase 3 development activities for sarecycline and is
preparing a new drug application for submission to the U.S.
Food and Drug Administration. Paratek retains all ex-U.S. rights to
sarecycline. Recognizing the serious threat of bacterial
infections, Paratek is dedicated to providing solutions that enable
positive outcomes and lead to better patient stories.
For more information, visit www.ParatekPharma.com or follow
@ParatekPharma on Twitter.
Forward Looking Statements
This 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: |
|
Investor
Relations: |
Michael Lampe |
|
Hans Vitzthum |
(484) 575-5040 |
|
LifeSci Advisors,
LLC. |
michael@scientpr.com |
|
212-915-2568 |
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