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RegeneRx says Phase 2 trial met primary outcome measure

RegeneRx Biopharmaceuticals announced results from its dose-escalating, double-blind, placebo-controlled Phase 2 clinical trial in 30 patients with dystrophic and junctional epidermolysis bullosa, a severe “orphan” skin disorder with limited prevalence in the U.S. and Europe. RGN-137 was administered to a single non-healing index lesion in these patients daily for 56 days and followed for an additional 14 days post-treatment. The clinical trial, initiated in 2006, met its primary outcome measure of safety. There were no serious adverse events associated with RGN-137 and the drug candidate was deemed safe and well-tolerated. The secondary outcome measures to determine the time, in number of days, to complete wound healing and the number of patients with complete wound healing could not be statistically measured due to too few patients with complete healing during the treatment period. The company performed an ad hoc analysis of all patients in the study to determine any differences in acceleration of wound healing in each of the three active dose groups and in the placebo group. The results indicated that there appeared to be improvements in acceleration of wound healing in every dose group over placebo. The mid-dose provided the best results, which was similar to results seen in two previously reported phase 2 dermal wound healing trials in non-EB patients with venous stasis and pressure ulcers.