Derma Sciences announces the termination of the Phase III aclerastide clinical trial for healing diabetic foot ulcer wounds owing to futility.
Derma Sciences, Inc. (NJ, USA), a tissue regeneration company focused on advanced wound and burn care, announced the termination of its Phase III clinical trials with aclerastide (DSC127) for diabetic foot ulcer healing. This action is based on futility determinations conducted by the Data Monitoring Committee (DMC) for the planned, pre-specified interim analyses regarding the primary efficacy endpoint of confirmed complete wound closure of the target ulcer within 12 weeks of the start of treatment. The decision to end the studies followed the recommendation by the DMC to stop enrollment in the studies. The DMC also reported that there were no safety concerns attributed to aclerastide.
“We are very disappointed with the findings of the analyses of the DMC, but are grateful for the support and commitment from the participating patients and the study investigators,” commented Edward J. Quilty, chairman and chief executive officer of Derma Sciences. “We have stopped further enrollment and initiated an orderly termination of the aclerastide trials and program, which we believe will be substantially complete by year end. We are also halting all development work with DSC127 in scar reduction and radiation dermatitis.”
The development program termination eliminates a projected cash burn of approximately $5 million per quarter in 2016. As of September 30, 2015 Derma Sciences had $49.4 million of cash and cash equivalents and $12.0 million of long-term investments.
The Company’s primary focus is to continue to grow its advanced wound care net sales and increase gross margins. The Derma Sciences Board of Directors and senior management are committed to a path of profitable growth and positive operating cash flow in 2016, including assessing all aspects of the Company’s operations and infrastructure that could enhance shareholder value