Debridement of serious burns
BioMarin, of Novato, CA, US, is developing Vibrilase as a topically applied enzyme for the debridement of serious burns.
BioMarin, of Novato, CA, US, is developing Vibrilase as a topically applied enzyme for the debridement of serious burns.
In the United States, approximately 45,000 serious burns require medical attention each year. In order to avoid infection and promote healing, the burned skin, or eschar, must be removed. This process is referred to as debridement. Conventional debridement methods employ surgical techniques, which are frequently associated with significant pain, blood loss and scarring, especially in burns covering a large fraction of the body.
But, the topical burn debridement agents currently available have a slow onset of action, and are associated with excessive pain due to their inability to discriminate between burned and healthy tissue.
Vibriolysin, the active enzyme component in Vibrilase, preferentially digests burned skin, leaving healthy tissue intact. It may meet the medical need for a product that will rapidly and safely debride partial thickness burns, by potentially reducing the incidence of infection, improving the outcomes of skin grafts on burns, and ultimately reducing the time to healing.
A Phase 1a, randomised, placebo-controlled, double blind study evaluated the dermal irritation and sensitisation potential of 100, 250, and 500 units per gram of Vibrilase in 118 healthy subjects at one site in the UK. Results indicate that Vibrilase produced no evidence of contact sensitisation or irritation for up to eight days, well beyond the expected 1-3 day treatment period in which Vibrilase would be applied.
A Phase 1b study was initiated in 2002 at one clinical site in the UK. Recently, in order to accelerate patient enrolment in the Phase 1b study, and to prepare for a Phase 2 trial, one additional site was added in Scotland, and a third site in the Netherlands is expected begin enrolling patients in the second quarter of 2003.
The Phase 1b study is an open-label, dose escalation and safety study, evaluating a total of 15 patients with partial thickness burns, with five patients at three doses; 100, 250, and 500 units per gram. Based on the trial protocol, patients 18 to 75 years of age with partial thickness burns over 1-25% of their bodies will receive Vibrilase for three consecutive days, and will be monitored for 28 days, or until healing occurs. BioMarin expects to complete the Phase 1b Vibrilase trial in the middle of 2003.