Derma Sciences, Inc. announced that in the follow-up portion of its Phase 2 clinical trial in patients with diabetic foot ulcers, the percentage of patients treated with the therapeutic dose of DSC127 with complete healing at 24 weeks following trial enrollment was 73% in the intent-to-treat (ITT) population and 85% in the per-protocol population (PP), a difference of 27 and 33 percentage points , respectively, compared with patients treated with placebo/standard of care (placebo).
DSC127 is a patented, topically applied novel angiotensin analog that targets receptors that are up-regulated upon injury to tissue.
Healing was defined as 100% epithelialized with no drainage. The company previously announced that the 0.03% dose of DSC127 exceeded the trial’s goal of an improvement of 15% in complete healing of wounds at 12 weeks for both the ITT and PP populations, compared with placebo. The improvement at 24 weeks between patients treated with DSC127 0.03% and patients treated with placebo is more pronounced. There were no drug-related adverse safety events during the entire 24-week study period.
The double-blind, placebo-controlled, multi-center Phase 2 clinical trial randomized 80 patients to receive one of two dose strengths of DSC127 (0.03% or 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.
Although the primary endpoint of the trial was healing at 12 weeks, patients continued to be followed for an additional 12 weeks to gain further information on the drug and its effects. Consistent with what was seen at week 12, the 0.01% dose of DSC127 continued to be comparable to placebo at week 24, and non-therapeutic.
Based on an odds-ratio analysis, patients treated with DSC127 0.03% are 3.2 times more likely to heal by 24 weeks for the ITT group, and 5.2 times more likely for the PP group, compared with placebo.
The median time to complete healing in the ITT population was 10.0 weeks for patients treated with DSC127 0.03% and 23.0 weeks for patients treated with placebo, and in the PP population was 8.5 weeks for patients treated with DSC127 0.03% and 22.0 weeks for patients treated with placebo.
Wounds that did not completely heal by study end re-epithelialized more rapidly as measured by a reduction of wound area of 72% greater in both the DSC127 0.03% ITT and PP groups compared with placebo. At week 24, the mean reduction of area from baseline for both the ITT and PP populations was 95% for patients treated with DSC127 0.03% and 23% for patients treated with placebo.
Granulation as measured by reduction in ulcer depth showed an improvement of 46% in the ITT group and 49% in the PP group over placebo. At week 24, the mean percent reduction of depth from baseline in the ITT population was 83% for patients treated with DSC127 0.03% and 37% for patients treated with placebo, and in the PP population was 89% for patients treated with DSC127 0.03% and 40% for patients treated with placebo.
No wounds treated with 0.03% DSC127 had increased in size by the end of the 24-week study, whereas some wounds treated with placebo had increased in size by the end of the 24-week period.
Release Date: May 25, 2011
Source: Derma Sciences, Inc.
Filed Under: Drug Discovery
