You are here

Positive Phase 3 Results Announced for Dalbavancin Studies

KING OF PRUSSIA, Pa., Aug. 12 /PRNewswire-FirstCall/ -- Vicuron Pharmaceuticals Inc. (Nasdaq: MICU; Nuovo Mercato: MICU) today 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. 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 U.S. Food and Drug Administration (FDA) later this year," said George F. Horner III, Vicuron's president and chief executive officer. "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," said Timothy J. Henkel, MD, PhD, chief medical officer of Vicuron. "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."

Phase III Study Design and Results
-- Complicated SSTIs: Randomized, controlled, double-blind study of 854 patients versus linezolid. The primary endpoint was clinical response at the follow-up visit in the evaluable patient population. Evaluable patients taking dalbavancin demonstrated an 88.9 percent response versus 91.2 percent for linezolid patients (95 percent confidence interval -7.3, 2.9). In the ITT group, dalbavancin patients showed a 76.5 percent response versus 82.7 for linezolid (95 percent confidence interval -12.0, -0.3). Dalbavancin was well tolerated in the study.

-- Uncomplicated SSTIs: Randomized, controlled, double-blind study of 565 patients versus intravenous cefazolin followed by oral cephalexin. The primary endpoint was clinical response at the follow-up visit in the evaluable patient population. Evaluable patients taking dalbavancin demonstrated an 89.1 percent response versus 89.1 percent for cefazolin (95 percent confidence interval -6.8, 6.8). In the ITT group, dalbavancin patients showed a 76.0 percent response versus a 75.8 percent response for cefazolin (95 percent confidence interval -7.7, 8.2). Dalbavancin was well tolerated in the study.

-- SSTIs caused by MRSA: Randomized, controlled, open-label study of 156 patients versus vancomycin in SSTIs suspected or confirmed to be caused by methicillin-resistant Staphylococcus aureus (MRSA). The primary endpoint was clinical response at the follow-up visit in the evaluable patient population. Evaluable patients taking dalbavancin demonstrated an 89.9 percent response versus 86.7 percent for vancomycin (95 percent confidence interval -13.0, 19.4). In the ITT group, dalbavancin patients showed an 86.0 percent response versus 65.3 percent for vancomycin (95 percent confidence interval 4.3, 37.0). Dalbavancin was well tolerated in the study. This study is not pivotal, but will be part of the NDA submission.

About Dalbavancin
Dalbavancin, a novel next-generation glycopeptide agent, belongs to the same class as vancomycin, the most widely-used and one of the few treatments available to patients infected with the most difficult-to- treat strains of Staphylococcus (Staph.): MRSA (methicillin-resistant Staphylococcus aureus) and MRSE (methicillin-resistant Staphylococcus epidermidis). Dalbavancin has been specifically designed as an improved alternative to vancomycin. In vitro studies have shown that in addition to being potent against clinically important Gram-positive bacteria, it is bactericidal (i.e., kills bacteria rather than merely inhibiting their growth). The potency, tissue penetration and long half-life of dalbavancin may allow for more flexible and convenient dosing regimens than vancomycin. Dalbavancin may also help reduce the length of hospital stays by decreasing the need for intravenous lines that increase the risk of local and bloodstream infection. In preclinical and clinical studies to date, dalbavancin appears to be one of the most potent antibiotics in its class against MRSA and MRSE and has not shown significant dose-limiting side effects.

Source: Vicuron Pharmaceuticals Inc.

Recent Headlines

Superior to Quinine in Reducing Mortality in Two Clinical Trials
Minimally Invasive Method Reduces Regurgitation and Leaking
Neurofilament Light Protein Correlated With Accumulated Brain Damage
Technology Designed to Improve Patient Care, Limit Infections
Medical Device Enables Nerve Stimulation During Sleep
May Offer Improved Safety Profile for Pediatric Patients
Hope for Sufferers With Post-Treatment Lyme Disease Syndrome
KardiaMobile Receives Two More Clearances for Arrhythmia Detection