DSC 127 (aclerastide) fails diabetic foot ulcer healing trial and programme is cancelled- Derma Sciences Inc.
Derma Sciences, a tissue regeneration company focused on advanced wound and burn care, announced the termination of its Phase III clinical trials with aclerastide (DSC 127) 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 enrolment in the studies. The DMC also reported that there were no safety concerns attributed to aclerastide.
Comment: Derma Sciences has stopped further enrolment and initiated an orderly termination of the aclerastide trials and programme, which it believes will be substantially complete by year end. The company is also halting all development work with aclerastide in scar reduction and radiation dermatitis.
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