Derma Sciences, Inc. a medical device and pharmaceutical company focused on advanced wound care, announced positive results from its phase II clinical trial with DSC127 in patients with diabetic foot ulcers, including meeting the trial's primary endpoint, the proportion of study ulcers healed by 12 weeks as defined by 100% epithelialized with no drainage, as well as all secondary endpoints measured at this time. DSC127 is a patented, topically applied novel angiotensin analogue that targets receptors that are up-regulated upon injury to tissue.
The double-blind, placebo-controlled, multi-centre clinical trial randomized 80 patients to receive one of two dose strengths of DSC127 (0.03% and 0.01%) or vehicle placebo control. After 14 days of best standard-of-care to evaluate ulcer healing and ensure the wounds were chronic, those patients randomized into the study received four weeks of active treatment followed by eight weeks of observation and assessment.
In the Intent-to-Treat (ITT) population: results show that 54 per cent of the diabetic wounds treated with the 0.03 per cent dose (high dose) of DSC127 achieved 100 per cent closure in 12 weeks or less, compared with 33 per cent of patients receiving placebo control, and 30 per cent of patients receiving the 0.01 per cent dose (low dose) of DSC127. Based on odds ratio analysis, patients treated with DSC127 0.03 per cent were 2.3 times more likely to have their wounds heal completely compared with patients treated with placebo/standard of care.
In the Per-Protocol (PP) population: results show that 65 per cent of the diabetic wounds treated with the 0.03 per cent dose of DSC127 achieved 100 per cent closure in 12 weeks or less, compared with 38 per cent of patients receiving placebo control, and 28 per cent of patients receiving the 0.01 per cent dose of DSC127. Based on odds ratio analysis, patients treated with DSC127 0.03 per cent were 3.0 times more likely to have their wounds heal completely compared with patients treated with placebo/standard of care.
The high dose of DSC127 exceeded the trial's primary endpoint measurement target of an improvement of 15 percentage points in complete healing of wounds within the 12-week duration of the study for both the ITT (21 percentage point increase) and PP (27 percentage point increase) populations, compared with placebo.
The trial was not powered for statistical significance, however there was a statistically significant (p=0.049) improvement in the rate of ulcer depth reduction in the PP high-dose population through 12 weeks of treatment compared with the control arm, using covariate analysis.
The drug was well-tolerated and there were no significant adverse events associated with DSC127 treatment. Further data on the durability of the healing effect is expected to be available late in the second quarter of 2011 after all patients with 100 per cent closed wounds have completed a subsequent 12 weeks of follow-up monitoring.
David Armstrong, MD of Southern Arizona Limb Salvage Alliance (SALSA) at the University of Arizona and the study's lead investigator, said, “The clinical results from this trial are very impressive as application of 0.03 per cent DSC127 appears to increase healing rates at a level greater than has been previously reported by drugs currently on the market and in development. Although further testing in a pivotal study is required, it seems that DSC127 has the potential to be an important therapy for the treatment of diabetic wounds.”
Derma Sciences chairman and chief executive officer Edward J. Quilty said, “Results from this phase II trial exceeded our expectations and we are delighted to be reporting such compelling results. Our next step in the development process is to discuss these results with the FDA in an end-of-phase II meeting, and to advance development into phase III. These results are transformational for Derma Sciences and we are looking forward to sharing these data with potential development and commercial partners, and to determining how best to maximize the considerable potential of DSC127 for our shareholders. We are hopeful that a phase III study will show comparably robust results and that, in due course, DSC127 will be brought to market to alleviate the suffering of millions of patients with these debilitating and stubborn wounds.”
Diabetes is common, disabling and deadly. In the US, diabetes has reached epidemic proportions. According to the American Diabetes Association, about 24 million people (8 per cent of the US population) have diabetes, and nearly 2 million new cases are diagnosed in people age 20 years or older each year. Up to 25 per cent of people with diabetes will develop a diabetic foot ulcer, resulting in 3 million diabetic foot ulcers annually in the US alone. A recent study by researchers at the University of Chicago suggested that treatment costs for diabetes in the United States would reach $336 billion by the year 2034. According to the World Health Organization, at least 220 million people worldwide have diabetes, a number that is expected to more than double by 2030, due mainly to obesity and aging.
DSC127, a novel angiotensin analogue, has been shown to improve epithelialization, granulation and vascularization, accelerating wound healing in a variety of normal and diabetic animal models. This finding suggests that DSC127 produces different actions at the wound site during various stages of healing. There were no safety concerns observed in the preclinical and human phase I studies of DSC127.
Derma Sciences is a medical technology company focused on three segments of the wound care marketplace, traditional dressings, advanced wound care dressings, and pharmaceutical wound care products. Its Medihoney product is the leading brand of honey-based dressings for the management of wounds and burns. The product has been shown to be effective in a variety of indications, and was the focus of a positive large-scale, randomized controlled trial involving 108 subjects with leg ulcers. Other novel products include Xtrasorb for better management of wound exudate, and Bioguard for infection prevention.