May 25 2011
Derma Sciences, Inc. (Nasdaq: DSCI), a medical device and pharmaceutical company focused on advanced wound care, today 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 (0.03%) 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 percentage points in complete healing of wounds at 12 weeks for both the ITT (21 percentage point increase) and PP (27 percentage point increase) populations, compared with placebo. With today's announcement, the improvement at 24 weeks between patients treated with DSC127 0.03% and patients treated with placebo is even 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 therefore non-therapeutic. The table below shows the percentage of patients healed at weeks 12 and 24, with the 0.03% dose of DSC127 and placebo.
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 patients treated with placebo.
The rate of healing as measured by median time to full closure was significantly faster in both ITT and PP groups compared with placebo, and reached statistical significance in the PP group.
In addition, wounds that did not completely heal by study end re-epithelialized more rapidly as measured by a reduction of wound area of 72 percentage points 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 percentage points in the ITT group and 49 percentage points 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.
David Armstrong, DPM, MD, PhD, Professor of Surgery and Director of the Southern Arizona Limb Salvage Alliance (SALSA) at the University of Arizona and the study's lead investigator, said, "The continuation of a widening gap between 0.03% DSC127 and placebo out to 24 weeks is both promising and intriguing. It potentially suggests a durable action by the drug that may last well beyond the initial four weeks of treatment. This type of response tracks well with the proposed method of action, interacting with receptors that are up-regulated at the time of injury, and helping to set those otherwise non-healing wounds on a trajectory towards healing. I would reiterate what I have said previously, that 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, "We are delighted that 24-week data show that DSC127 0.03% continues to have a therapeutic effect, long after the patients stop using it. These results are even better than we had hoped for, and unequivocally support the continued development of this drug. The market potential of DSC127 is very large, and growing rapidly throughout the world. We are very excited about the potential of DSC127 for patients, healthcare practitioners and our shareholders.
"This summer, we will request an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to discuss our Phase 2 clinical trial results, our continued development plan to commercialization and our proposed protocol for the Phase 3 pivotal trials that we plan to begin in the first half of 2012. We are in discussions with several potential collaboration partners, but as previously announced, in order to maximize the value of DSC127, we plan to advance this drug to Phase 3 readiness, which includes the development of the Phase 3 clinical trial design and the completion of certain non-clinical activities. Should Phase 3 clinical studies show comparably robust results to our Phase 2 clinical trial and DSC127 be approved, this drug's benefits to the medical community, and most importantly, the patients could be substantial," Mr. Quilty concluded.
Source: Derma Sciences, Inc.
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