Pharmaceutical Business review

Derma Sciences diabetic ulcer drug meets primary endpoint

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.