Durata Therapeutics, Inc. (NASDAQ: DRTX) today announced
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).
Preliminary top-line data show that dalbavancin achieved its
primary endpoint of non-inferiority (10% non-inferiority margin) 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. 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. In addition, the key secondary endpoints were
supportive of the primary endpoint.
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(FDA) based on the FDA’s Draft Guidance for Developing Drugs for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 DISCOVER 1
Trial
Primary Endpoint, Early Response (48-72 hours)
Dalbavancin Vancomycin/Linezolid Difference in point
estimates
(95% Confidence Interval)
Early Response (ITT) 239/288
(83.0%)
233/285
(81.8%)
1.2% (-4.9, 7.6)
Secondary Endpoint, End of Treatment,
Day 14
Dalbavancin Vancomycin/
Linezolid
Clinical Status (CE) 214/246
(87.0%)
222/243
(91.4%)
Clinical Status (ITT) 236/288
(81.9%)
247/285
(86.7%)
ITT = Intent to Treat; CE = Clinically Evaluable
In the clinical trial, the treatment-related adverse event rate
for dalbavancin was 12.3% and for vancomycin/linezolid was 18.3%.
Adverse events reported in ≥ 3% of patients receiving dalbavancin
in this trial were nausea, diarrhea, headache, and pruritus.
Discontinuations due to treatment emergent adverse events were 1.8%
and 2.1% for dalbavancin and vancomycin/linezolid, respectively.
This adverse event profile is consistent with results from prior
Phase 3 studies of dalbavancin. Further analyses, including the
statistical analyses for the European regulatory submission, remain
ongoing.
“We are very pleased with the preliminary results of this trial.
There is a significant need for an innovative treatment option for
patients suffering with ABSSSI. We anticipate results from our
DISCOVER 2 study in the coming months and are proceeding toward
submitting to the FDA a New Drug Application for dalbavancin in the
first half of 2013,” said Durata Chief Executive Officer Paul R.
Edick.
“The development of new products, such as dalbavancin, makes
this a very exciting time for patients and healthcare
practitioners. Currently available IV treatment options for ABSSSI
have limitations, including frequent dosing, antimicrobial
resistance, and treatment-limiting adverse events. The potential
opportunity to manage more patients more efficiently in ambulatory
settings may well be an important advancement for providers of
healthcare,” said David Andrew Talan, MD, FACEP, FIDSA, Chairman,
Department of Emergency Medicine and Faculty, Division of
Infectious Diseases, Olive View-UCLA Medical Center.
“We believe there are approximately 35 million days of IV
antibiotic treatment annually in the United States for patients
with ABSSSI that are at risk for MRSA, with the majority of these
treatments occurring in the hospital setting. Because therapy with
dalbavancin would involve an initial dose followed by a second dose
one week later, an alternative to hospital admission may become
possible for many patients. This change in modality may help reduce
the overall cost of treating ABSSSI to the healthcare provider
while decreasing the potential spread of MRSA within the healthcare
facility,” said Durata Chief Medical Officer Michael Dunne,
M.D.
Additional information regarding the trial can be found on
clinicaltrials.gov.
Conference Call and Webcast
Information
The company will host a conference call today, Tuesday, December
11, 2012 at 9:00 a.m. ET To access the call, please dial
866-632-4021 for participants in the U.S. or Canada and
404-991-3968 for international callers (reference Conference ID
79502265). A replay of the call may be accessed through December
25, 2012 by dialing 800-585-8367 for callers in the U.S. and Canada
and (404) 537-3406 for international callers (reference Conference
ID 79502265). The conference call will also be webcast live at
http://event.on24.com/r.htm?e=554781&s=1&k=657C1386D7A8EC4FF7537AD9D0271CE4.
About Dalbavancin
Dalbavancin is an intravenous antibiotic product candidate under
investigation for once-weekly dosing, 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 its DISCOVER 1 study and enrollment in its DISCOVER 2
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.
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
timing of the filing of a New Drug Application with the U.S. Food
and Drug Administration, 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.
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