Vicuron Pharmaceuticals Inc announced results from pivotal phase III clinical trials comprising more than 1,500 patients evaluating once-weekly dalbavancin in skin and soft tissue infections (SSTIs) caused by Gram-positive bacteria.
According to a release from Vicuron, all three studies met the primary endpoint of non-inferiority in evaluable patients' clinical response at two weeks following therapy when compared to linezolid, cefazolin or vancomycin, the three most widely administered standard-of-care agents for SSTIs. All studies also met the secondary endpoint of non-inferiority in clinical response for the intent-to-treat (ITT) patient population. Dalbavancin was also shown to be well tolerated.
"Based on this compelling data, we plan to file a New Drug Application (NDA) with the US FDA later this year," said George F Horner III, Vicuron's president and chief executive officer. He added, "We look forward to working through the FDA to move this important new antibiotic toward the market."
The vast majority of the patients treated in these studies had SSTIs caused by Staphylococcus (Staph) aureus bacteria, with more than 400 patients infected with methicillin-resistant Staphylococcus aureus (MRSA), one of the most difficult-to-treat strains of bacteria. SSTIs are some of the most common infections seen in the clinic and hospital. Postoperative surgical site infections are one of the major sources of these infections.
"The consistent response versus standard of care we observed with dalbavancin across all three studies is extremely encouraging," Timothy J Henkel, chief medical officer of Vicuron said adding, "Dalbavancin has the potential to become an important new agent in the physician's armamentarium to treat serious skin and soft tissue infections caused by a broad spectrum of Gram-positive bacteria."