MediWound Announces New EscharEx庐 Phase II Data Demonstrating Strong Link Between Wound Bed Preparation and Wound Closure in Venous Leg Ulcers
MediWound (Nasdaq: MDWD) has published new Phase II data analysis for EscharEx庐 in the treatment of venous leg ulcers (VLUs) in Advances in Wound Care journal. The study, analyzing 119 VLU patients, demonstrated a significant correlation between wound bed preparation (WBP) and wound closure.
Key findings revealed that wounds achieving WBP were 4.1 times more likely to close compared to those that did not (p = 0.0004). Notably, wounds failing to achieve WBP had a 90% probability of not healing. Early WBP achievement (within 14 days) showed a significantly increased healing likelihood (Relative Risk = 2.4). The study validates EscharEx's potential in accelerating wound bed preparation for improved healing outcomes.
MediWound (Nasdaq: MDWD) ha pubblicato una nuova analisi dei dati di Fase II su EscharEx庐 nel trattamento delle ulcere venose della gamba (VLU) sulla rivista Advances in Wound Care. Lo studio, che ha analizzato 119 pazienti con VLU, ha evidenziato una correlazione significativa tra la preparazione del letto della ferita (WBP) e la chiusura della ferita.
I risultati principali mostrano che le ferite che raggiungevano la WBP avevano 4,1 volte pi霉 probabilit脿 di chiudersi rispetto a quelle che non la raggiungevano (p = 0.0004). In particolare, le ferite che non raggiungevano la WBP avevano una probabilit脿 del 90% di non guarire. Il conseguimento precoce della WBP (entro 14 giorni) aumentava significativamente la probabilit脿 di guarigione (Rischio Relativo = 2,4). Lo studio conferma il potenziale di EscharEx nel velocizzare la preparazione del letto della ferita per migliorare gli esiti di guarigione.
MediWound (Nasdaq: MDWD) ha publicado una nueva an谩lisis de datos de Fase II sobre EscharEx庐 para el tratamiento de las 煤lceras venosas de la pierna (VLU) en la revista Advances in Wound Care. El estudio, que analiz贸 a 119 pacientes con VLU, demostr贸 una correlaci贸n significativa entre la preparaci贸n del lecho de la herida (WBP) y el cierre de la misma.
Los hallazgos clave revelaron que las heridas que alcanzaron la WBP ten铆an 4,1 veces m谩s probabilidades de cerrarse en comparaci贸n con las que no lo hicieron (p = 0.0004). Cabe destacar que las heridas que no alcanzaron la WBP ten铆an una probabilidad del 90% de no curarse. Lograr la WBP de forma temprana (en 14 d铆as) aument贸 significativamente la probabilidad de curaci贸n (Riesgo Relativo = 2,4). El estudio valida el potencial de EscharEx para acelerar la preparaci贸n del lecho de la herida y mejorar los resultados de curaci贸n.
MediWound (Nasdaq: MDWD)臧� Advances in Wound Care 鞝�雱愳棎 頃橃鞝曤Д甓れ枒(VLU) 旃橂毳� 鞙勴暅 EscharEx庐鞚� 2靸�(Phase II) 雿办澊韯� 攵勳劃 瓴瓣臣毳� 氚滍憸頄堨姷雼堧嫟. 119氇呾潣 VLU 頇橃瀽鞚� 攵勳劃頃� 鞚� 鞐瓣惮電� 靸侅矘 氚旊嫢 欷�牍�(WBP)鞕� 靸侅矘 韽愳噭 臧勳潣 鞙犾潣頃� 靸侁磤甏�瓿勲ゼ 氤挫棳欤检棃鞀惦媹雼�.
欤检殧 瓴瓣臣鞐� 霐半ゴ氅� WBP毳� 雼劚頃� 靸侅矘電� 雼劚頃橃 氇豁暅 靸侅矘氤措嫟 4.1氚� 雿� 旃橃湢霅� 臧�電レ劚鞚� 雴掛晿瓿�(p = 0.0004), WBP毳� 雼劚頃橃 氇豁暅 靸侅矘電� 旃橃湢霅橃 鞎婌潉 頇曤鞚� 90%鞐� 雼枅鞀惦媹雼�. 霕愴暅 14鞚� 鞚措偞鞐� WBP毳� 臁瓣赴鞐� 雼劚頃� 瓴届毎 旃橃湢 臧�電レ劚鞚� 鞙犾潣頃橁矊 歃濌皜頄堨姷雼堧嫟(靸侂寑鞙勴棙霃� = 2.4). 鞚� 鞐瓣惮電� EscharEx臧� 靸侅矘 氚旊嫢 欷�牍勲ゼ 臧�靻嶍檾頃橃棳 旃橃湢 瓴瓣臣毳� 臧滌劆頃� 靾� 鞛堧姅 鞛犾灛霠レ潉 鞛呾頃╇媹雼�.
MediWound (Nasdaq: MDWD) a publi茅 dans la revue Advances in Wound Care une nouvelle analyse des donn茅es de phase II sur EscharEx庐 pour le traitement des ulc猫res veineux de la jambe (VLU). L'茅tude, portant sur 119 patients atteints de VLU, a montr茅 une corr茅lation significative entre la pr茅paration du lit de la plaie (WBP) et la fermeture de la plaie.
Les r茅sultats cl茅s r茅v猫lent que les plaies ayant atteint la WBP avaient 4,1 fois plus de chances de se fermer que celles qui ne l'ont pas fait (p = 0.0004). Notamment, les plaies n'ayant pas atteint la WBP pr茅sentaient une probabilit茅 de 90 % de ne pas gu茅rir. L'obtention pr茅coce de la WBP (dans les 14 jours) augmentait significativement la probabilit茅 de cicatrisation (Risque Relatif = 2,4). L'茅tude valide le potentiel d'EscharEx pour acc茅l茅rer la pr茅paration du lit de la plaie et am茅liorer les r茅sultats de cicatrisation.
MediWound (Nasdaq: MDWD) hat in der Fachzeitschrift Advances in Wound Care eine neue Phase-II-Datenanalyse zu EscharEx庐 in der Behandlung von ven枚sen Beingeschw眉ren (VLU) ver枚ffentlicht. Die Studie, die 119 VLU-Patienten analysierte, zeigte eine signifikante Korrelation zwischen Wundbettvorbereitung (WBP) und Wundverschluss.
Wesentliche Ergebnisse zeigten, dass Wunden, die eine WBP erreichten, 4,1-mal wahrscheinlicher zuwuchsen als solche, die dies nicht taten (p = 0.0004). Auff盲llig war, dass Wunden, die keine WBP erreichten, eine 90%ige Wahrscheinlichkeit hatten, nicht zu heilen. Ein fr眉hzeitiges Erreichen der WBP (innerhalb von 14 Tagen) erh枚hte die Heilungswahrscheinlichkeit signifikant (Relatives Risiko = 2,4). Die Studie best盲tigt das Potenzial von EscharEx, die Wundbettvorbereitung zu beschleunigen und so bessere Heilungsergebnisse zu erzielen.
- Strong statistical significance (p = 0.0004) showing wounds with WBP are 4.1x more likely to close
- High negative predictive value of 90% validates the clinical importance of the treatment
- Early WBP achievement (14 days) showed 2.4x higher likelihood of healing
- Publication in a leading peer-reviewed journal adds credibility to findings
- Study was a post-hoc analysis, which may be considered less robust than pre-planned analyses
- Limited sample size of 119 patients may affect broader applicability of results
Insights
MediWound's EscharEx Phase II data shows wound bed preparation directly correlates with healing success, validating its clinical potential in venous leg ulcers.
The recently published post-hoc analysis of MediWound's Phase II trial provides compelling evidence supporting EscharEx's mechanism of action and clinical utility. The data reveals a critical insight about chronic wound healing: wounds that failed to achieve proper wound bed preparation (WBP) had a 90% probability of not healing at all. This remarkably high negative predictive value establishes WBP as not merely helpful but essentially prerequisite for healing.
The 4.1-fold increased likelihood of closure in wounds achieving WBP demonstrates the statistical significance of this correlation (p=0.0004). Particularly notable is the timing factor - early WBP achievement (within 14 days) was associated with a 2.4x higher healing rate. The 12-fold increased risk of wounds remaining unhealed without proper WBP (p<0.0001) further reinforces this relationship.
What makes this study particularly valuable is that it provides quantifiable evidence for what wound care specialists have long theorized - that proper debridement and granulation tissue development are rate-limiting steps in chronic wound healing. For venous leg ulcers, which affect millions globally and often remain unhealed for months or years, this data establishes clear treatment endpoints that correlate with ultimate healing success.
This validation of EscharEx's therapeutic approach strengthens its clinical positioning in the chronic wound care market, where effective debridement solutions that can accelerate the preparation phase represent a significant unmet need.
MediWound Announces New EscharEx庐 Phase II Data Demonstrating Strong Link Between Wound Bed Preparation and Wound Closure in Venous Leg Ulcers
Post hoc analysis published in Advances in Wound Care, provides clinical evidence supporting wound bed preparation as a critical step in the healing process
YAVNE, Israel, August 13, 2025 (GLOBE NEWSWIRE) 鈥� MediWound Ltd. (Nasdaq: MDWD), a global leader in next-generation enzymatic therapeutics for tissue repair, today announced the of聽 鈥�The Correlation Between Wound Bed Preparation and Wound Closure in Venous Leg Ulcers: A Post Hoc Analysis of the ChronEx Multicenter Randomized Controlled Trial鈥�, in Advances in Wound Care, a leading peer-reviewed journal focused on tissue injury and repair. The publication presents data demonstrating a strong correlation between wound bed preparation (WBP) and wound closure in patients with chronic venous leg ulcers (VLUs).
The analysis includes data from 119 chronic VLU patients randomized in a 3:3:2 ratio to receive up to two weeks of daily treatments with either EscharEx, a placebo gel vehicle, or non-surgical standard of care, followed by standard dressings applied weekly for 12 weeks. The incidence of wound closure was compared between patients who achieved WBP by day 14 and those who did not, as well as between those who achieved WBP at any time and those who did not. WBP was defined as complete removal of nonviable tissue and full coverage of the wound bed with healthy granulation tissue.
Key Findings:
- Wounds that failed to achieve WBP had a
90% probability of not healing (Negative Predictive Value =90% ) - Wounds that achieved WBP were 4.1 times more likely to close compared to those that did not (p = 0.0004)
- Early achievement of WBP (within 14 days) was associated with a significantly increased likelihood of healing (Relative Risk = 2.4, p =0.0005)
- Wounds that failed to reach WBP had a 12-fold higher risk of remaining unhealed throughout the study period (Hazard Ratio = 12, p < 0.0001)
These findings reinforce the clinical importance of complete debridement and timely full granulation tissue coverage in facilitating wound closure. The data further validates EscharEx鈥檚 therapeutic potential to improve healing outcomes by accelerating wound bed preparation in patients with venous leg ulcers.
Dr. Marissa J. Carter, a clinical trial specialist and biostatistician focused on chronic wound care research, emphasized the broader implications of the results: 鈥淲hile wound bed preparation has long been accepted as the conceptual foundation for managing chronic wounds, this landmark analysis provides evidence, for the first time, that there is a strong correlation between the two. Importantly, the findings indicate a high negative predictive value associated with the lack of wound bed preparation. In other words, wounds that are not adequately prepared are highly unlikely to proceed to closure, underscoring the essential role of wound bed preparation in the healing process. Without adequate wound bed preparation, chronic wounds rarely heal.鈥�
About EscharEx庐
EscharEx庐 is a bromelain-based, bioactive enzymatic therapy in advanced clinical development for the debridement of chronic and hard-to-heal wounds. Designed for topical, once-daily application, EscharEx has demonstrated a favorable safety profile and effective wound bed preparation in multiple Phase II trials. The therapy has shown the ability to remove non-viable tissue, promote granulation tissue, and reduce bioburden and biofilm. A global Phase III study in venous leg ulcers (VLUs) is currently underway, with a clinical study in diabetic foot ulcers (DFUs) in preparation. EscharEx has shown clinical advantages over the leading enzymatic debridement product and targets a substantial global market opportunity.
About MediWound
MediWound Ltd. (Nasdaq: MDWD) is a global biotechnology company focused on developing and commercializing enzymatic therapies for non-surgical tissue repair. The company鈥檚 FDA-approved biologic, NexoBrid庐, is indicated for the enzymatic removal of eschar in thermal burns and is marketed in the U.S., European Union, Japan, and other international markets. MediWound is also advancing EscharEx庐, a late-stage investigational therapy for the debridement of chronic wounds. EscharEx has demonstrated clinical advantages over the leading enzymatic debridement product and targets a substantial global market opportunity.
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MediWound cautions you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as 鈥渁nticipates,鈥� 鈥渋ntends,鈥� 鈥渆stimates,鈥� 鈥減lans,鈥� 鈥渆xpects,鈥� 鈥渃ontinues,鈥� 鈥渂elieve,鈥� 鈥済uidance,鈥� 鈥渙utlook,鈥� 鈥渢arget,鈥� 鈥渇uture,鈥� 鈥減otential,鈥� 鈥済oals鈥� and similar words or phrases, or future or conditional verbs such as 鈥渨ill,鈥� 鈥渨ould,鈥� 鈥渟hould,鈥� 鈥渃ould,鈥� 鈥渕ay,鈥� or similar expressions.
Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, expected data timing, objectives anticipated timelines, expectations and commercial potential of our products and product candidates, including EscharEx庐 and NexoBrid庐. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; the approval of regulatory submission by the FDA, the European Medicines Agency or by any other regulatory authority, our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth, including our ability to develop new products; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional financing; the impact of government laws and regulations and the impact of the current global macroeconomic climate on our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates in the future.
These and other significant factors are discussed in greater detail in MediWound鈥檚 annual report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission (鈥淪EC鈥�) on March 19, 2025 and Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound鈥檚 current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.
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