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MediWound Announces Positive Results from its U.S. Phase 2 Pharmacology Study of EscharEx for Debridement of Lower Leg Ulcers
EscharEx Showed Safe, Effective and Rapid Debridement in VLUs and DFUsData Demonstrates EscharEx Reduced Wound Size, Biofilm and Bacterial Burden YAVNE,
About this update from Mediwound Ltd.
[{"type":"text","content":"EscharEx Showed Safe, Effective and Rapid Debridement in VLUs and DFUsData Demonstrates EscharEx Reduced Wound Size, Biofilm and Bacterial Burden YAVNE, Israel, July 07, 2022 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD) (the “Company”), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced positive results from its U.S. prospective, open-label, single-arm, Phase 2 pharmacology clinical study of EscharEx® for the debridement of lower leg ulcers. The study was designed to evaluate the clinical performance, safety and pharmacology effect of EscharEx in debridement of venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs). Seventy percent of patients achieved complete debridement during the course of treatment within up to 8 applications. On average, complete debridement was achieved after 3.9 applications of EscharEx. Additionally, an average reduction of 35% in wound size was achieved by the end of the 2-week follow-up period. In all patients that were positive for biofilm at baseline, the biofilm was reduced substantially to single individual microorganisms or completely removed by the end of treatment. Seven patients had positive red fluorescence (indicative of bacteria) at baseline and average red fluorescence was reduced from 1.69 cm2 pre-treatment to 0.60 cm2 post treatment. Biomarker analysis from wound fluid is on-going and safety data shows that EscharEx is safe and well-tolerated. “The data from our pharmacology study corroborates the results of our previous Phase 2 studies, and clearly supports EscharEx as a potential rapid and effective, non-surgical debriding agent,” said Ofer Gonen, Chief Executive Officer of MediWound. “We are encouraged by the accumulated clinical data and believe that EscharEx, with its attractive product profile, has the potential to become a best-in-class non-surgical debridement option for the millions of patients suffering from chronic wounds.” Dr. Robert Snyder, Chief Medical Director of EscharEx program added, “We are excited to see the data showing that EscharEx could effectively debride wounds while disrupting biofilm and lowering bacterial load. There is wide consensus among clinicians that infection and microbial biofilm impedes the healing process and prolongs wound healing. We thank our...