Durata Therapeutics, Inc. 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Draft Guidance for Developing Drugs for Treatment of ABSSSI.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)
Difference in point
estimates
Dalbavancin Vancomycin/Linezolid
(95% Confidence
Interval)
Early Response 239/288 233/285
(ITT) 1.2% (-4.9, 7.6)
(83.0%) (81.8%)
Secondary Endpoint, End of Treatment, Day 14
Vancomycin/
Dalbavancin
Linezolid
214/246 222/243
Clinical Status (CE)
(87.0%) (91.4%)
236/288 247/285
Clinical Status (ITT)
(81.9%) (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.
Market News and Data brought to you by Benzinga APIs© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Loading...
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in