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May 21, 2014
07:05 EDTMDWDMediWound initiates second Phase 2 clinical trial of EscharEx
MediWound announces initiation of its second Phase 2 clinical trial of EscharEx to treat chronic and other hard-to-heal wounds. EscharEx is based on MediWound's patented proteolytic enzyme technology. This prospective, randomized, controlled, multicenter Phase 2 study of approximately 72 subjects is planned to be conducted at approximately 10 clinical sites and intends to evaluate safety and efficacy of EscharEx compared with gel vehicle for the treatment of a variety of chronic and other hard-to-heal wounds, including diabetic foot ulcers, or DFUs, venous ulcers and post-surgical or traumatic hard-to-heal wounds. The blinded study intends to assess non-viable tissue removal, wound bed preparation and wound healing as well as other additional endpoints. The Company has concluded a Phase 2 feasibility study of EscharEx to treat chronic and other hard-to-heal wounds in 24 patients at two clinical sites in Israel. The results from that trial demonstrated efficacy in debriding various wound etiologies such as DFUs, venous ulcers, pressure sores and other post-surgical or post-trauma hard-to-heal wounds.
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February 2, 2016
16:59 EDTMDWDMediWound says second EscharEx Phase 2 clinical trial meets primary endpoint
MediWound announces positive top-line results from the company's second Phase 2 clinical trial evaluating EscharEx for debridement of dead or damaged tissue in chronic and other hard-to-heal wounds. EscharEx is based on the same propriety proteolytic enzyme technology used in MediWound's NexoBrid, which is approved and commercially available in Europe and Israel for the removal of eschar in adults with deep partial- and full-thickness thermal burns. Effective debridement is a critical first step to facilitate wound management and is complementary to existing wound healing products, which require a clean wound bed. This trial was the second Phase 2 trial with EscharEx, following a feasibility Phase 2 trial, conducted in Israel with 24 patients that demonstrated the ability of EscharEx to debride chronic and hard-to-heal wounds of various etiologies. The objectives of this second Phase 2 trial were to evaluate the efficacy of EscharEx in debriding chronic wounds, to assess its safety and lack of deleterious effect on wound healing and to further analyze these effects in different etiologies to guide the design of future pivotal studies. The study met its primary endpoint with statistical significance. Patients treated with EscharEx demonstrated a higher incidence of complete debridement compared with patients treated with the hydrogel vehicle. The study included secondary endpoints that provide further insight on a number of efficacy and safety parameters. The secondary endpoint of time to complete debridement demonstrated a clear trend that strongly suggests that not only is there a difference in the incidence of debridement, as confirmed by the primary endpoint, but that debridement occurred earlier in the group treated by EscharEx.

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