Durata Announces Supportive Data Analysis from Phase 3 Dalbavancin Trial at ECCMID Meeting
Retrospective Analysis Evaluated Endpoints in Accord with New FDA Guidelines for Antibiotic Development
Durata Commenced New Pivotal, Phase 3 Study of Dalbavancin under FDA Special Protocol Assessment (SPA) in April 2011
MORRISTOWN, N.J.--(BUSINESS WIRE)--May 9, 2011 - Durata Therapeutics today announced supportive, retrospective data from a previously completed global, Phase 3 study of the Company's lead product, dalbavancin, a long-acting, intravenous (IV) lipoglycopeptide. As reported in a poster presentation titled, “Dalbavancin vs Linezolid for Treatment of Acute Bacterial Infections of the Skin: A Comparison of Early and Standard Outcome Measures in Study VER001-9”, a reanalysis of data from that Phase 3 study demonstrated that clinical efficacy associated with dalbavancin was again similar to linezolid, in these analyses based on both resolution of fever and cessation of spread of the lesion within a 48- to 96-hour period after the start of therapy. Recently, the Food and Drug Administration (FDA) issued new draft guidance establishing that antibiotic effectiveness be assessed between 48 and 72 hours following initiation of therapy.
The retrospective analyses from the Phase 3 study were presented at the 21st European Congress of Clinical Microbiology and Infectious Diseases 2011 (ECCMID) at the Milano Convention Centre in Milan, Italy. According to the original study protocols, patients with complicated skin and skin structure infections (SSSIs), including infections known or suspected to involve methicillin-resistant Staphylococcus aureus (MRSA), were randomized (ratio, 2:1) in a double-blind manner to receive dalbavancin (1000 mg given intravenously on day 1 and 500 mg given intravenously on day 8) or linezolid (600 mg given intravenously or intravenously/orally every 12 h for 14 days). The primary efficacy endpoint of clinical success was assessed by determining clinical and microbiological responses at the test-of-cure (TOC) visit at 28 days following initiation of therapy. A successful clinical response was one in which signs and symptoms of SSSI had improved such that no further antibacterial therapy was warranted. As previously reported, the trial met the original endpoint, demonstrating non-inferiority to linezolid at 28 days.
George H. Talbot, M.D., author on the Phase 3 study abstract and principal of Talbot Advisors LLC, commented, “Given the evolving regulatory requirements for design and conduct of clinical trials of acute bacterial SSSI, Durata deserves kudos for completing this further analysis of the VER001-9 study and publication of the results. These data will inform all future trials of antibacterials intended for treatment of serious acute bacterial SSSI, including those caused by MRSA, and as such is a very meaningful contribution to public health at a time when the antibiotic pipeline continues to be at risk."
In April 2011, Durata commenced a global, pivotal, Phase 3 study (DISCOVER-1) of dalbavancin under a Special Protocol Assessment (SPA) agreed upon with the FDA. The study is designed to compare the efficacy and safety of dalbavancin to vancomycin and is expected to enroll approximately 556 patients worldwide. Patients will be randomized to receive either two doses of dalbavancin, each infused over 30 minutes, one week apart from each other, or 10 to 14 days of the comparator regimen. Clinical response will be measured at 48 to 72 hours post study initiation and again at study day 14-15.
Durata's Chief Executive Officer, Paul Edick, stated, “We believe our growing database of safety and efficacy for dalbavancin is unparalleled. The results presented at ECCMID, which will form a part of our submission to the regulatory authorities, further add to our confidence that we will be able to achieve our endpoints in the ongoing DISCOVER-1 study. Durata is well-positioned to meet the new FDA guidelines as we continue enrollment in our pivotal study and prepare to bring this much-needed therapy to patients.”
To learn more about Durata's ongoing pivotal study for dalbavancin, please visit http://clinicaltrials.gov/ct2/show/NCT01339091?term=dalbavancin&rank=2.
About Durata Therapeutics
Durata Therapeutics is a biopharmaceutical company addressing the growing need for new therapeutics to treat infectious diseases. Durata's current late-stage clinical product, dalbavancin, is a next-generation lipoglycopeptide with unique features, including convenient, once-a-week dosing. To date, dalbavancin has been shown to be effective and well-tolerated in late-stage clinical trials of patients with skin infections, supported by a promising safety profile based on clinical data in over 1300 patients. Durata has worldwide rights for the development and commercialization of dalbavancin. The Company also has two antibiotic programs in earlier-stage, preclinical research.
Durata's senior leadership has considerable experience in running healthcare companies and broad expertise in medical affairs, operations, manufacturing and commercialization, including multiple U.S. and global product launches. Durata is supported by a premier team of venture capital organizations including New Leaf Venture Partners, LLC, Domain Associates, LLC, Aisling Capital, Sofinnova Ventures Inc. and Canaan Partners.
For more information on Durata and the Company's programs, please visit www.duratatherapeutics.com.
Justin Jackson, 212-213-0006
Corey Fishman, 973-993-4865
Chief Operating Officer
Posted: May 2011