Durata Therapeutics Announces Phase 3 Clinical Trial Results for Dalbavancin in the Treatment of ABSSSI
NASDAQ: DRTX) today announced preliminary, top-line results for its DISCOVER 1 (“Dalbavancin for Infections of the Skin COmpared to Vancomycin at an Early Response”) Phase 3 study of dalbavancin, which is under investigation for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria, including MRSA (methicillin resistant Staphylococcus aureus).
Preliminary top-line data show that dalbavancin achieved its primary endpoint of non-inferiority (10% non-inferiority margin) at 48-72 hours after initiation of therapy, as determined by the cessation of spread of the lesion, as well as the resolution of fever. Researchers were comparing two intravenous (IV) doses of dalbavancin given one week apart with twice-daily vancomycin doses for 14 days. Patients randomized to the vancomycin regimen had an option to switch to oral linezolid after three days of vancomycin treatment. In addition, the key secondary endpoints were supportive of the primary endpoint.
The DISCOVER 1 protocol was conducted pursuant to a special protocol agreement (SPA) with the U.S. Food and Drug Administration (FDA) based on the FDA's Draft Guidance for Developing Drugs for Treatment of ABSSSI. The protocol for the trial was also designed based on scientific advice provided by the European Medicines Agency (EMA). DISCOVER 1 was a randomized, double-blind, double-dummy trial conducted in 573 patients at 92 sites in the United States, Canada, and Europe comparing dalbavancin to a regimen of vancomycin and an option for oral linezolid for the treatment of ABSSSI.
Pfizer aquired Dalbavancin back in 05 when it bought Vacuron pharma. In 08 Pfizer announced that it will withdraw all marketing apps. Dureta aquired the rights in 09. Due to their toxicity, use of glycopeptide antibiotics is restricted to patients who are critically ill. Some tissues are not penetrated and they do not penetrate the cerebrospinal fluid. Brock
Dalbavancin is a second generation lipoglycopeptide antibiotic. It belongs to the same class a Vancomycin. It has a much longer half life of about 300 hours thus the initial dose and then another dose a week later. Same old problem. Resistance development. Brilacidin on the other hand is a one to three day dosing with a 17 hour half life that kills all the bacteria with little chance of resistance occuring. Really no comparison. Brock