U.S. regulators have agreed to phase 3 clinical trials for an advanced wound care device and drug developer’s treatment for diabetic foot ulcers following positive data from its phase 2 clinical trial.
Derma Science‘s (NASDAQ:DSCI) topical treatment, DSC127, is designed to treat foot ulcers that develop in up to 25 percent of diabetics by helping to accelerate the healing process.
More than 60 percent of nontraumatic, lower-limb amputations occur in people with diabetes and in 2006, about 65,700 nontraumatic, lower-limb amputations were performed in people with diabetes, according to a company statement. About 80 percent of these amputations were preceded by a foot ulcer, according to data from the National Institutes of Health.
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The Princeton, New Jersey-based company, citing data from Susquehanna Research, said diabetic foot ulcers affect 900,000 people annually in the United States. The company estimates the value of the diabetic foot ulcer treatment market at $3 billion.
Edward J. Quilty, CEO of Derma Sciences, said in a company statement that it will begin manufacturing DSC127 to support the pivotal trials and pharmacokinetic studies. He said patient recruitment for the phase 3 trial is scheduled to begin in the second half of the year.
The product faces competition from at least three other companies who have had treatments on the market for years: Shire’s acquisition of Advanced BioHealing last year added Dermagraft gel to its product portfiolio; Organogenisis’ Apligraf, which received FDA approval in 1998; and Healthpoint Biotherapeutics’ Regranex gel, which carries a black-box warning.
