Study Results Support Company’s Planned NDA for Dalbavancin
Durata Therapeutics Presents Results from Skin Lesion Measurement Study at IDWeek 2012
Allison WeyDurata TherapeuticsVice President, Investor Relations and Public Affairs(312) 612-5462orJed WeinerWhite Oak Communications, Inc.(847) 392-4186orAllison WeyDurata TherapeuticsVice President, Investor Relations and Public Affairs(312) 612-5462
Durata Therapeutics (NASDAQ: DRTX) today announced data from a multicenter, observational study related to the clinical development program of its lead product candidate, dalbavancin. The results demonstrate the reliability of the measurement tools deployed by Durata Therapeutics in its two ongoing, global, Phase 3 clinical trials for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria.
The data are being presented at the Novel Antimicrobial Agents session of IDWeek in San Diego. IDWeek is the first-ever combined meeting of four prestigious societies: the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), and the Pediatric Infectious Diseases Society (PIDS).
The U.S. Food and Drug Administration (FDA) issued Draft Guidance in August 2010 that redefines the primary endpoint to be used in clinical trials to support an indication for the treatment of acute bacterial skin and skin structure infections (ABSSSI). The endpoint requires documentation of both cessation of spread of any cellulitis (skin infection) associated with the infection, as well as resolution of fever. This study was designed to provide evidence of reproducibility of the measurements of the erythema (skin redness) associated with these lesions.
In this study, 42 patients meeting criteria for an ABSSSI were enrolled and 39 were evaluated. Overall, both the repeated (intra-) observer and between (inter-) observer ruler measurements showed almost perfect reliability with ICC’s >0.9 for area, length and width. The percent differences in ruler measurements between different observers were slightly larger than between repeated measurements by the same individual (17.4% vs. 4.1%, respectively). Variability was higher in smaller lesions.
There was almost perfect intra-observer reliability (ICC>0.9) comparing the longest and shortest lesion measurements by ruler compared to measurements derived programmatically from a computer-assisted planimetry assessment of lesions taken from the transparency grid. Lesions measured by digital camera and transparency were 35% and 31% smaller than the ruler, respectively.
“Study investigators concluded that measurement of the erythema associated with an ABSSSI can be reliably performed using a ruler,” said the study’s lead author and Durata Chief Medical Officer Michael Dunne, M.D. “These results validate the technique we are using to measure the primary endpoint in our Phase 3 clinical trials. We intend to submit this information with the New Drug Application (NDA) for dalbavancin in the first half of 2013.”
Durata will display data from this and another dalbavancin-related trial (Poster Number 1622) in San Diego Convention Center Halls F-H from Thursday, October 18 at 9:30 a.m. until Saturday, October 20 at 6:00 p.m. Dr. Dunne will be at the poster for discussion on Saturday, October 20, 12:30 – 2:00 p.m. PT.
For more information on the two studies presented at IDWeek 2012, visit .
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.
Durata Therapeutics is a pharmaceutical company focused on the development and commercialization of novel therapeutics for patients with infectious diseases and acute illnesses. Durata is currently enrolling and dosing patients in 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.
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