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news.The Phase II clinical trial of DC127 carried out by Derma Sciences to treat diabetic foot ulcers has met the primary endpoint.
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DSC127 is a patented, topically applied novel angiotensin analog that targets receptors that are up-regulated following injury to tissue.
The double-blind, placebo-controlled, multi-centre clinical trial enrolled 80 patients who were randomised to receive one of two dose strengths of DSC127 (0.03% and 0.01%) or vehicle placebo control.
In the Intent-to-Treat (ITT) population, the study results showed that 54% of the patients treated with the 0.03% dose of DSC127 and 30% of patients treated with 0.01% dose achieved 100% diabetic wound closure in 12 weeks or less, compared to 33% of patients receiving placebo control.
Based on odds ratio analysis, patients receiving DSC127 0.03% were 2.3 times more likely to have their wounds completely healed compared to patients receiving placebo/standard of care.
In the Per-Protocol (PP) population, 65% of the patients treated with the 0.03% dose of DSC127 and 38% of patients treated with 0.01% dose achieved 100% diabetic wound closure in 12 weeks or less, compared to 28% of patients receiving placebo control.
Based on odds ratio analysis, patients receiving DSC127 0.03% were 3 times more likely to have their wounds completely healed compared to patients receiving placebo/standard of care.
Reportedly, the drug was well-tolerated in the study, with no significant adverse events.