Durata Therapeutics announced that the company has initiated enrollment in a second global, pivotal, phase III study (Discover-2) of its lead product, dalbavancin, a long-acting, intravenous (IV) lipoglycopeptide for the treatment of acute bacterial skin and skin structure infections (abSSSI). Durata’s two pivotal studies (Discover-1 and Discover-2) are being conducted under separate Special Protocol Assessments (SPA) agreed upon with the US Food and Drug Administration (US FDA).

Durata also announced it has reached 20 per cent patient enrollment in the company’s Discover-1 study. Each of the pivotal studies is expected to enroll 556 patients, for a combined total of 1112 patients.

Durata’s chief medical officer, Michael Dunne, MD, stated, “Discover-1 and Discover-2, together with a third, previously reported phase III trial, will constitute a substantial body of safety and efficacy data, with results from over 2000 patients. Upon conclusion of the clinical programme, dalbavancin will have a very substantial body of evidence in support of treatment for bacterial skin infections in both the hospital and community settings.”

Durata’s chief medical officer, Michael Dunne, MD, stated, “Dalbavancin is one of the most advanced of the next-generation lipoglycopeptides, in the same class as vancomycin. Due to its unique features and PK profile, dalbavancin offers the significant convenience of once-a-week dosing and short, 30-minute infusion time. Based on these characteristics, the safety data in over 1300 patients, and our expectations for the pivotal program, we believe this product has the potential to set the bar for activity against important Gram-positive bacterial infections, including those due to Methicillin-Resistant Staphylococcus Aureus (MRSA).”

Durata’s Discover-2 study is a randomized, double-blind, double-dummy study designed to compare the efficacy and safety of dalbavancin to vancomycin, with patients randomized to vancomycin allowed to switch to oral linezolid after three days of IV vancomycin therapy. The study 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. These measures are consistent with current draft FDA guidance for the development of antibiotics to treat acute bacterial skin and skin structure infections.

Vance G. Fowler Jr., MD, MHS, associate professor, Department of Medicine, Division of Infectious Diseases and International Health, Duke University Medical Centre, commented, “According to the Infectious Disease Society of America, an estimated 100,000 hospital deaths a year in the U.S. can be attributed to resistant bacteria, such as MRSA. The threat posed by antibiotic resistance continues to grow, and yet there is a paucity of new antibiotics that are being introduced to fight these infections. Efforts such as those of Durata can be critical to finding new treatments to fill this need.”

“Since Durata’s acquisition of dalbavancin in December 2009, the clinical program has progressed rapidly and has met many important milestones,” stated Paul R. Edick, chief executive officer of Durata. “Both of our pivotal clinical studies are now underway, and we anticipate the same active level of investigator engagement in Discover-2 as we have seen with Discover-1. SPA agreement with the FDA also has been a critical achievement, especially in light of the FDA’s efforts to complete guidelines for abSSSI antibiotic development. In addition, Durata announced successful production of clinical quantities of dalbavancin by two top-tier manufacturers, a key step in ensuring supply of the product. Also, we recently reported we attained worldwide rights for the dalbavancin programme, another value inflection point. We are very pleased with our progress and look forward to continued momentum of the program.”

Durata Therapeutics is a biopharmaceutical company addressing the growing need for new therapeutics to treat infectious diseases.