Durata Therapeutics Initiates Enrollment in a Phase 3b Study of Dalvance in 1500 mg Single Dose

Durata Therapeutics, Inc. DRTX today announced that it has initiated enrollment of a Phase 3b clinical trial to evaluate the efficacy and safety of its investigational product, Dalvance™ (dalbavancin) for injection, in a single 1500 milligram dose infused over 30 minutes in adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria. "Our pharmacokinetic studies have indicated that there may be clinical efficacy in dosing Dalvance as a single 1500 mg infusion over 30 minutes to treat ABSSSI," said Michael Dunne, MD, Chief Medical Officer of Durata Therapeutics. "We are committed to advancing the care of patients with ABSSSI and potentially offering health care professionals an opportunity to choose the most appropriate dosing regimen based on patient and clinical needs." Durata Therapeutics submitted a New Drug Application (NDA) in September 2013 seeking approval of Dalvance for the treatment of ABSSSI with a once-weekly dosage regimen of 1000 mg on Day 1 and 500 mg on Day 8, each administered over 30 minutes. The NDA was accepted for priority review by the FDA in November 2013 with an action date of May 26, 2014. SINGLE DOSE STUDY DESIGN The Phase 3b, multicenter, double-blind, randomized, controlled study compares a single dose of Dalvance with the once-weekly dosage regimen of Dalvance in adult patients with ABSSSI known or suspected to be caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). Approximately 410 adult patients will be randomized to receive either one 1500 mg single dose of Dalvance on Day 1 or two doses of Dalvance with 1000 mg on Day 1 followed by 500 mg on Day 8. All doses will be administered over 30 minutes through a peripheral IV. For presumed Gram-negative pathogens, only IV aztreonam may be administered at randomization; for suspected anaerobic pathogens, oral or IV metronidazole may be used. Other antibiotics are prohibited. The primary outcome measure for efficacy evaluation will be the percentage of patients in each treatment group who demonstrate a clinical response at 48-72 hours after the initiation of therapy with study medication. The study was designed to meet the new standards required by regulatory authorities for antibiotic development in the United States.