Vicuron Pharmaceuticals announced positive results from a Phase II trial of its lead antibiotic product candidate, dalbavancin, for skin and soft tissue infections (SSTIs) were presented in an oral presentation at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID).
In the Phase II trial, the top-line results of which were previously reported, dalbavancin, a new semi-synthetic glycopeptide antibiotic, given once a week for two weeks, was shown to be effective in treating deep SSTIs and to be well tolerated. The once-weekly regimen produced higher clinical and microbiological response rates than a variety of standard care regimens.
"Potential advantages of once-weekly dosing of intravenous dalbavancin compared with existing therapies are convenient administration, a reduced need for intravenous lines that can prolong the risk of local and bloodstream infection and resultant shorter hospital stays," said Timothy J. Henkel, chief medical officer of Vicuron and one of the co-authors of the oral presentation. "Studies of dalbavancin to date have shown that our antibiotic has potent in vivo and in vitro activity against key Gram-positive bacteria, excellent tissue penetration and a favorable side effect profile."
Currently, once-weekly administration of dalbavancin is being studied in randomized, controlled, double-blinded Phase III clinical trials of complicated and uncomplicated SSTIs. Also underway is a Phase II study of dalbavancin for the treatment of patients with catheter-related bloodstream infections. Vicuron expects to complete Phase III trials in the first half of 2004 and to file a New Drug Application for dalbavancin with the U.S. Food and Drug Administration in the second half of 2004.
"Dalbavancin is being developed as the first once-weekly injectable hospital-based antibiotic for serious Gram-positive infections, including the most resistant strains of Staph. No other marketed or investigational product offers this type of dosing convenience," said George F. Horner III, president and CEO of Vicuron. "The need for innovative antibiotics to treat serious and often deadly hospital-based bacterial infections is becoming more critical due to increasing rates of such infections and the rise in bacterial resistance, creating a large market opportunity for novel agents like dalbavancin."