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    MDWD   IL0011316309

MEDIWOUND LTD.

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Mediwound Announces Positive Topline Results from Its U.S. Phase 2 Trial of Escharex for Debridement of Chronic Wounds

01/24/2022 | 06:00am EDT

MediWound Ltd. announced positive topline results from its U.S. Phase 2 clinical study of EscharEx® for the debridement of venous leg ulcers (VLUs). The study met its primary endpoint, demonstrating that patients treated with EscharEx had a statistically significant higher incidence of complete debridement compared to the gel vehicle, with a p-value of 0.004. The study randomized 120 patients, of which 119 patients were treated by either EscharEx (n=46), a gel vehicle (n=43), or a non-surgical standard-of-care consisting of either enzymatic or autolytic debridement (n=30). The study met its primary endpoint with high degree of statistical significance. Patients treated with EscharEx demonstrated a higher incidence of complete debridement during the 14-day measurement period within up to 8 applications compared to patients treated with gel vehicle (EscharEx: 63% (29/46) vs. gel vehicle: 30% (13/43), p-value=0.004). After adjusting for pre-specified covariates ascribed to patient baseline characteristics, wound size and age, regions, and sites, EscharEx efficacy superiority remained statistically significant compared to gel vehicle. Incidence of complete debridement of the non-surgical standard-of-care arm, during the same 14-day measurement period, was 13% (4/30). In addition, the Independent Data Monitoring Committee reviewed the data of all patients treated and no safety concerns were identified in the study population. EscharEx was well-tolerated and overall safety was comparable between the arms. No differences were found in reported adverse events and no serious adverse event was related to study treatment. Patient baseline characteristics were comparable across all study arms. Patient follow-up is ongoing and additional data, including secondary and exploratory endpoints as well as additional safety measurements, which will allow further evaluation of clinical benefits, is expected in the second quarter of 2022. MediWound currently expects to request an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (the “FDA”) in the second half of 2022, to discuss program results and the potential Phase 3 pivotal plan for EscharEx.


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Financials (USD)
Sales 2022 20,9 M - -
Net income 2022 -11,6 M - -
Net Debt 2022 - - -
P/E ratio 2022 -5,48x
Yield 2022 -
Capitalization 61,1 M 61,1 M -
Capi. / Sales 2022 2,92x
Capi. / Sales 2023 2,20x
Nbr of Employees -
Free-Float 59,6%
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Sharon Malka Chief Executive Officer
Boaz Gur-Lavie Chief Financial Officer
Stephen T. Wills Executive Chairman
Lior Rosenberg Chief Medical Officer
Ety Klinger Chief Research & Development Officer
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