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SAN FRANCISCO, Oct. 2, 2013 (GLOBE NEWSWIRE) -- Durata Therapeutics, Inc. (Nasdaq:DRTX) today announced a comprehensive review of the efficacy, safety and microbiology data of the company's lead product candidate, dalbavancin, for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI). The data is being presented in six posters at this year's IDWeek 2013™, held in San Francisco, Calif., October 2-6, 2013. Among the findings, an integrated analysis of two Phase 3 clinical studies (DISCOVER 1 and 2) showed dalbavancin met its primary and secondary endpoints of early response, measured at 48 to 72 hours of therapy, as well as clinical success at the end of treatment. Sensitivity analyses for both timepoints were also included.
i A separate analysis showed that patients achieving cessation of spread of the lesion after 72 hours of antibiotic treatment with dalbavancin have a greater than 90 percent chance of being cured at the end of treatment.
ii A pooled summary analysis of the safety profile of dalbavancin based on the Phase 2 and 3 clinical program also found it to be generally well-tolerated and to have a similar safety profile to comparators with fewer adverse events.
iii Examination of patients with baseline Gram-positive bacteremia enrolled in the dalbavancin clinical development program as well as
in vitro activity against methicillin-resistant
Staphylococcus aureus (MRSA) and
Neisseria gonorrhoeae were also presented.
"The data show that dalbavancin has the potential to be an efficacious and well-tolerated treatment option for patients with ABSSSI," said Durata Therapeutics Chief Medical Officer Michael Dunne, M.D. "Our studies were designed to meet the new standards required by regulatory authorities for antibiotic development in the United States and European Union and support our New Drug Application submission to the Food and Drug Administration late last week."
Dalbavancin is a novel antibacterial under investigation for the treatment of ABSSSI caused by susceptible Gram-positive microorganisms, such as
S. aureus (including MRSA and other multi-drug resistant strains) and
Streptococcus pyogenes, as well as certain other streptococcal species. Dalbavancin is bactericidal against Gram-positive bacteria and is administered with a once-weekly dosage regimen of 1000 mg on Day 1 and 500 mg on Day 8, over 30 minutes by intravenous infusion.
Copies of the following posters will be available on Durata Therapeutics' website:
Poster # 1339: An Integrated Analysis of the Efficacy of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) in the DISCOVER Program i (Date: October 5, 2013)
Data were presented from an integrated analysis of the efficacy results from the DISCOVER ("
Infections of the
Vancomycin at an
Response") program and found that dalbavancin is non-inferior to the comparator regimen at both an early timepoint and at the end of therapy. The DISCOVER program includes two Phase 3 identically designed multicenter, double-blind, randomized clinical trials of more than 1,300 adult patients with ABSSSI from the United States, Europe, Asia and South Africa. Patients were treated for two weeks either with intravenous dalbavancin once weekly (1000 mg on Day 1 followed by 500 mg on Day 8) or with intravenous vancomycin (1000 mg or 15 mg/kg every 12 hours) with the option to switch to oral linezolid after three days. Primary endpoints from the DISCOVER trials were cessation of spread of the erythema associated with the lesion and resolution of fever measured at 48-72 hours per FDA requirements. While a secondary endpoint for FDA, clinical success at end of treatment is the expected primary endpoint for regulatory review in Europe. Examining both endpoints provides clinicians with correlation between the early and late findings.
The integrated efficacy analysis found that:
Dalbavancin had similar efficacy rates relative to the comparator regimen in demonstrating the combination of cessation of lesion spread and absence of fever 48-72 hours following initiation of treatment
Success rates at the Day 14 end of treatment and the Day 28 follow up visit were similar in both treatment groups
Poster # 1340: Concordance of Clinical Response at 48-72 Hours after Initiation of Therapy and End of Treatment (EOT) in Patients with Acute Bacterial Skin and Skin Structure Infection (ABSSSI) in the DISCOVER Studies ii (Date: October 5, 2013)
An additional analysis of the DISCOVER clinical trials examined the concordance of study endpoints (i.e., clinical response at 48-72 hours after initiation of therapy as well as at the end of treatment) and found that the majority of early responders were ultimately cured. Specifically, the analysis found that:
The majority (945/1,046, 90.3%) of patients who responded favorably to treatment with dalbavancin by 48 to 72 hours were ultimately cured by the end of treatment
Most (129/182, 70.9%) patients who were non-responders on Day 3 were also subsequently cured by the end of treatment
Patients who do not achieve cessation of lesion spread at 72 hours alone and have worsening pain have an 80 percent chance of ultimately failing treatment
"The early assessment timepoint recommended by the FDA was put in place to guide antibiotic drug development for ABSSSI," said Mark Wilcox, M.D., Head of Microbiology, Leeds Teaching Hospitals and Professor of Medical Microbiology at the University of Leeds, UK and an advisor to the DISCOVER clinical trial program. "These data, however, may also give physicians confidence at an early timepoint that could help identify patients who could ultimately be cured and those who might fail."