Durata Therapeutics Meets Primary Endpoints for EMA Review in Phase 3 Clinical Trial
January 04 2013 - 8:30AM
Durata Therapeutics, Inc. (Nasdaq:DRTX) today announced additional
preliminary, top-line results for its DISCOVER 1
("
Dalbavancin for
Infections of
the
Skin
COmpared to
Vancomycin at an
Early
Response") Phase 3 study of dalbavancin, which is
under investigation for the treatment of acute bacterial skin and
skin structure infections (ABSSSI) caused by susceptible
gram-positive bacteria, including MRSA (methicillin resistant
Staphylococcus aureus). As reported on December 11, 2012,
preliminary top-line data show that dalbavancin achieved its
primary endpoint of non-inferiority at 48-72 hours after initiation
of therapy, as determined by the cessation of spread of the lesion,
as well as the resolution of fever. The subpopulation of patients
with MRSA at baseline achieved similar results. The secondary
endpoint of clinical success at the end of treatment, the expected
primary endpoint for regulatory review in Europe, was also met.
Statistical analyses of the results from this secondary endpoint
are included below in the updated table of top-line data.
Researchers were comparing two intravenous (IV) doses of
dalbavancin given one week apart with twice-daily vancomycin doses
for 14 days. Patients randomized to the vancomycin regimen had an
option to switch to oral linezolid after three days of vancomycin
treatment. The DISCOVER 1 protocol was conducted pursuant to a
special protocol agreement (SPA) with the U.S. Food and Drug
Administration (FDA) based on the FDA's Draft Guidance for
Developing Drugs for Treatment of ABSSSI. The protocol for the
trial was also designed based on scientific advice provided by the
European Medicines Agency (EMA). DISCOVER 1 was a randomized,
double-blind, double-dummy trial conducted in 573 patients at 92
sites in the United States, Canada, and Europe comparing
dalbavancin to a regimen of vancomycin and an option for oral
linezolid for the treatment of ABSSSI.
Top-line Data
from the DISCOVER 1 Trial |
|
Endpoint |
Dalbavancin |
Vancomycin/ linezolid |
Difference in point estimates (95%
Confidence interval) |
US Primary Endpoint |
Early response (48-72 hours) |
240/288 (83.3%) |
233/285 (81.8%) |
1.5% (-4.6, 7.9) |
|
Patients with MRSA |
37/44 (84.1%) |
32/39 (82.1%) |
|
|
Endpoint |
Dalbavancin |
Vancomycin/ linezolid |
Difference in point estimates (95%
Confidence interval) |
EMA Primary Endpoint |
Clinical Status (End of Treatment) |
214/246 (87.0%) |
222/243 (91.4%) |
-4.4% (-9.6, 1.6)* |
|
Patients with MRSA |
30/35 (85.7%) |
30/31 (96.8%) |
|
|
Investigator Assessment (End of
Treatment) |
233/246 (94.7%) |
237/243 (97.5%) |
-2.8% (-6.7, 0.7) |
*adjusted for pre-specified
baseline variables. |
Additional information regarding the trial can be found on
clinicaltrials.gov.
"These data are consistent with our previous phase 3 study,
VER001-9, which served as the pivotal study in our prior NDA
submission and confirm the activity of dalbavancin in the treatment
of patients with serious skin infections," said Dr. Michael Dunne,
Chief Medical Officer.
Paul R. Edick, Durata's Chief Executive Officer, states, "We
anticipate reporting DISCOVER 2 preliminary top-line results this
quarter and, along with DISCOVER 1 and the reanalysis of the
VER001-9 study, we believe that we have the data we need to
re-activate our dalbavancin NDA in the US and file our MAA in the
EU with a filing to the FDA in the middle of 2013 and to the EMA at
the end of 2013."
About Dalbavancin
Dalbavancin is an intravenous antibiotic product candidate under
investigation for once-weekly dosing given twice, which we believe
may facilitate the treatment of patients with ABSSSI in both the
in-patient and out-patient settings, potentially reducing the
length of a patient's hospital stay or avoiding hospital admission
altogether, with an impact on the overall cost of care for these
patients.
About Durata Therapeutics
Durata Therapeutics is a pharmaceutical company focused on the
development and commercialization of novel therapeutics for
patients with infectious diseases and acute illnesses. Durata has
completed two global Phase 3 clinical trials with its lead product
candidate, dalbavancin, for the treatment of patients with acute
bacterial skin and skin structure infections, or ABSSSI.
The Durata Therapeutics, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=16463
Forward-looking statements
Statements contained in this press release contain
forward-looking statements that involve substantial risks and
uncertainties. All statements, other than statements of historical
facts, contained in this press release, including statements
regarding our strategy, future operations, future financial
position, future revenues, projected costs, prospects, plans and
objectives of
management, are forward-looking statements. The words
"anticipate," "believe," "estimate," "expect," "intend," "may,"
"plan," "predict," "project," "target," "potential," "will,"
"would," "could," "should," "continue," and similar expressions are
intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words.
Forward-looking statements in this press release include
statements about the preliminary top-line results of the DISCOVER I
trial, the status of the DISCOVER 2 trial, and the content and
timing of the filing of a New Drug Application with the U.S. Food
and Drug Administration and the content and timing of the filing of
an Marketing Authorization Application in the EU, our estimates
regarding the potential market opportunity for dalbavancin and the
potential advantages of dalbavancin. Actual results may differ
materially from those indicated by these forward-looking statements
as a result of various important factors, including those discussed
in the "Risk Factors" section of our most recent quarterly report
on Form 10-Q, which is on file with the SEC and is also available
on our website. In addition, any forward-looking statements
represent our views only as of today and should not be relied upon
as representing our views as of any subsequent date. While we may
elect to update these forward-looking statements at some point in
the future, we specifically disclaim any obligation to do so, even
if our views change. Therefore, you should not rely on these
forward-looking statements as representing our views as of any date
subsequent to today.
CONTACT: Investor Relations and Public Affairs Contact
Allison Wey
Durata Therapeutics
Vice President, Investor Relations and Public Affairs
(312) 219-7017
awey@duratatherapeutics.com
Media Relations Contact
Jed Weiner
White Oak Communications, Inc.
(847) 392-4186
jed.weiner@comcast.net
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