BioMarin Pharmaceutical Inc announced positive results from a Phase 1b clinical trial of Vibrilase (vibriolysin), an investigational topical enzyme for the treatment of serious burns. Data from the trial suggest that treatment with Vibrilase is generally safe and well-tolerated, and effective in debriding partial-thickness burns. The data was presented at the 12th Congress of the International Society for Burn Injuries in Yokohama, Japan, by Peter Dziewulski clinical investigator at Broomfield Hospital in the United Kingdom.

The open-label trial enrolled 19 patients with partial-thickness burns covering 1 to 2 percent of the total body surface area. Conscious patients were treated daily for three days with one of three doses of topically-applied Vibrilase: 100 U/g, 250 U/g, and 500 U/g. Patients were followed for a total of 28 days, or until complete wound healing occurred. Key findings from the trial include- Efficacy -Data on the debridement of wound eschar (removal of burned tissue) were analyzed from seven evaluable patients and data on the time to 90 per cent epithelialization (the point at which wounds appear to be healing normally) were analyzed from 12 evaluable patients where it was found that the average time to complete debridement of wound eschar was 2.9 days and the average time to 90 per cent epithelialization was 16.4 days, a company release said.

"The use of topical burn wound debriding agents has stimulated interest for some time, but the choice of agents has been limited to products with poor efficacy and tolerability profiles," stated Peter Dziewulski, clinical investigator at Broomfield Hospital in the United Kingdom. "Vibrilase offers an exciting new opportunity in burn care and recent clinical trials, although only treating a small number of patients, demonstrate its potential as an effective and well-tolerated product candidate. Further clinical studies are warranted to confirm the benefits of Vibrilase as a burn debridement agent," he added.

Previously, data were reported from a Phase 1a, randomized, placebo-controlled, double-blind trial that evaluated the dermal irritation and sensitization potential of three doses of topically applied Vibrilase, 100 U/g, 250 U/g, and 500 U/g, in 118 healthy subjects at one site in the United Kingdom. Results from this trial indicated that Vibrilase produced no evidence of contact sensitization or irritation for up to eight days, well beyond the expected one to three day treatment period in which Vibrilase would be applied.

Vibriolysin, the active enzyme component in Vibrilase, preferentially digests burned skin, leaving healthy tissue intact, thereby reducing pain associated with treatment. Vibrilase may meet the medical need for a product that can rapidly and safely debride partial-thickness burns by potentially reducing the incidence of infection, improving the outcomes of skin grafts, and ultimately reducing the time to healing.