MediWound Announces Publication of Phase II EscharEx® Data Demonstrating Superiority Over Collagenase in Venous Leg Ulcers
MediWound (NASDAQ: MDWD) published a post hoc analysis in Wounds journal comparing their EscharEx® treatment to SANTYL® for venous leg ulcers (VLUs). The analysis, based on Phase II ChronEx trial data, demonstrated superior clinical performance of EscharEx over SANTYL, the only FDA-cleared enzymatic debridement agent currently available.
Key findings showed that 63% of EscharEx patients achieved complete debridement at 2 weeks versus 0% in the SANTYL group. The median time to debridement was 9 days for EscharEx, while SANTYL did not achieve this milestone. Wound Bed Preparation was achieved by 50% of EscharEx patients in 2 weeks compared to 0% with SANTYL. Notably, wound closure rates were 33% for EscharEx versus 25% for SANTYL, with significantly faster mean time to closure (48 days vs. 76 days). Both treatments showed similar safety profiles, though deep wound infection rates were lower in the EscharEx group (11% vs. 38%).
MediWound (NASDAQ: MDWD) ha pubblicato un'analisi post hoc sulla rivista Wounds, confrontando il loro trattamento EscharEx® con SANTYL® per le ulcere venose degli arti inferiori (VLU). L'analisi, basata sui dati del trial di Fase II ChronEx, ha dimostrato la superiore efficacia clinica di EscharEx rispetto a SANTYL, l'unico agente enzimatico per il debridement approvato dalla FDA attualmente disponibile.
I risultati principali hanno mostrato che il 63% dei pazienti trattati con EscharEx ha raggiunto un debridement completo in 2 settimane, contro lo 0% nel gruppo SANTYL. Il tempo mediano per il debridement è stato di 9 giorni per EscharEx, mentre SANTYL non ha raggiunto questo risultato. La preparazione del letto della ferita è stata ottenuta dal 50% dei pazienti EscharEx in 2 settimane rispetto allo 0% con SANTYL. Notevolmente, i tassi di chiusura della ferita sono stati del 33% per EscharEx contro il 25% per SANTYL, con un tempo medio di chiusura significativamente più rapido (48 giorni contro 76 giorni). Entrambi i trattamenti hanno mostrato profili di sicurezza simili, sebbene i tassi di infezione profonda della ferita fossero inferiori nel gruppo EscharEx (11% contro 38%).
MediWound (NASDAQ: MDWD) publicó un análisis post hoc en la revista Wounds comparando su tratamiento EscharEx® con SANTYL® para úlceras venosas en las piernas (VLU). El análisis, basado en datos del ensayo de Fase II ChronEx, demostró un rendimiento clínico superior de EscharEx sobre SANTYL, el único agente de desbridamiento enzimático aprobado por la FDA actualmente disponible.
Los hallazgos clave mostraron que el 63% de los pacientes tratados con EscharEx lograron un desbridamiento completo en 2 semanas, frente al 0% en el grupo SANTYL. El tiempo medio para el desbridamiento fue de 9 días para EscharEx, mientras que SANTYL no alcanzó este hito. La preparación del lecho de la herida se logró en el 50% de los pacientes con EscharEx en 2 semanas comparado con 0% con SANTYL. Notablemente, las tasas de cierre de la herida fueron del 33% para EscharEx frente al 25% para SANTYL, con un tiempo medio hasta el cierre significativamente más rápido (48 días frente a 76 días). Ambos tratamientos mostraron perfiles de seguridad similares, aunque las tasas de infección profunda de la herida fueron menores en el grupo EscharEx (11% frente a 38%).
MediWound (NASDAQ: MDWD)는 Wounds 저널에 후향적 분석 결과를 발표하며, 정맥성 하지 궤양(VLU)에 대한 EscharEx® 치료법과 SANTYL®을 비교했습니다. 이 분석은 2상 ChronEx 임상시험 데이터를 기반으로 하며, 현재 FDA 승인된 유일한 효소적 데브리드먼트 제제인 SANTYL보다 EscharEx가 임상적으로 우수한 성과를 보임을 입증했습니다.
주요 결과는 EscharEx 환자의 63%가 2주 내에 완전한 데브리드먼트를 달성한 반면, SANTYL 그룹은 0%에 그쳤습니다. 데브리드먼트 중간 시간은 EscharEx가 9일인 반면, SANTYL은 이 기준에 도달하지 못했습니다. 상처 바닥 준비(Wound Bed Preparation)는 EscharEx 환자의 50%가 2주 내에 달성했으나, SANTYL은 0%였습니다. 특히, 상처 폐쇄율은 EscharEx가 33%, SANTYL이 25%였으며, 평균 폐쇄 시간도 EscharEx가 48일로 SANTYL의 76일보다 훨씬 빨랐습니다. 두 치료법 모두 유사한 안전성 프로필을 보였으나, 심부 상처 감염률은 EscharEx 그룹이 11%로 SANTYL의 38%보다 낮았습니다.
MediWound (NASDAQ : MDWD) a publié une analyse post hoc dans la revue Wounds comparant leur traitement EscharEx® à SANTYL® pour les ulcères veineux des jambes (VLU). L'analyse, basée sur les données de l'essai de phase II ChronEx, a démontré la performance clinique supérieure d'EscharEx par rapport à SANTYL, le seul agent enzymatique de débridement approuvé par la FDA actuellement disponible.
Les résultats clés ont montré que 63 % des patients traités avec EscharEx ont obtenu un débridement complet en 2 semaines contre 0 % dans le groupe SANTYL. Le temps médian pour le débridement était de 9 jours pour EscharEx, alors que SANTYL n'a pas atteint ce jalon. La préparation du lit de la plaie a été obtenue par 50 % des patients EscharEx en 2 semaines contre 0 % avec SANTYL. Notamment, les taux de fermeture des plaies étaient de 33 % pour EscharEx contre 25 % pour SANTYL, avec un temps moyen de fermeture significativement plus rapide (48 jours contre 76 jours). Les deux traitements ont montré des profils de sécurité similaires, bien que les taux d'infection profonde de la plaie soient plus faibles dans le groupe EscharEx (11 % contre 38 %).
MediWound (NASDAQ: MDWD) veröffentlichte eine Post-hoc-Analyse im Wounds Journal, in der ihre Behandlung EscharEx® mit SANTYL® bei venösen Beingeschwüren (VLU) verglichen wurde. Die Analyse, basierend auf Daten der Phase-II-ChronEx-Studie, zeigte die überlegene klinische Wirksamkeit von EscharEx gegenüber SANTYL, dem derzeit einzigen von der FDA zugelassenen enzymatischen Débridement-Mittel.
Wesentliche Ergebnisse zeigten, dass 63% der EscharEx-Patienten innerhalb von 2 Wochen eine vollständige Débridement erreichten, während dies in der SANTYL-Gruppe 0% waren. Die mediane Zeit bis zum Débridement betrug 9 Tage für EscharEx, während SANTYL diesen Meilenstein nicht erreichte. Die Wundbettvorbereitung wurde bei 50% der EscharEx-Patienten in 2 Wochen erreicht, verglichen mit 0% bei SANTYL. Bemerkenswert waren die Wundverschlussraten von 33% für EscharEx gegenüber 25% für SANTYL, mit einer deutlich schnelleren durchschnittlichen Verschlusszeit (48 Tage vs. 76 Tage). Beide Behandlungen zeigten ähnliche Sicherheitsprofile, wobei die Raten tiefer Wundinfektionen in der EscharEx-Gruppe niedriger waren (11% vs. 38%).
- EscharEx achieved 63% complete debridement rate at 2 weeks vs 0% for SANTYL
- Faster median time to debridement (9 days for EscharEx vs not achieved for SANTYL)
- Higher wound bed preparation success rate (78% vs 38% over 12 weeks)
- Faster mean time to wound closure (48 days vs 76 days)
- Lower deep wound infection rate (11% vs 38%)
- Small sample size in SANTYL group (n=8) compared to EscharEx group (n=46)
- Wound closure rate difference was not statistically significant (33% vs 25%)
Insights
MediWound's EscharEx outperformed SANTYL in Phase II trial, showing faster debridement, better wound preparation, and comparable safety in venous leg ulcers.
The publication of MediWound's Phase II ChronEx trial in Wounds journal demonstrates significant clinical advantages of EscharEx® over SANTYL® (collagenase ointment) in treating venous leg ulcers (VLUs). The post hoc analysis compared 46 EscharEx patients with 8 SANTYL patients, revealing striking performance differences.
The most compelling evidence lies in debridement efficacy, where EscharEx achieved
Particularly noteworthy is wound bed preparation (WBP), a critical precursor to healing defined as complete debridement plus complete granulation. EscharEx achieved
While wound closure rates weren't statistically different (
These results suggest EscharEx's bromelain-based formulation may provide a substantial advancement over the only current FDA-cleared enzymatic debridement agent for dermal ulcers. The data indicates potential for improved clinical outcomes and possibly reduced treatment duration for the millions suffering from chronic VLUs.
Post hoc analysis published in the peer-reviewed journal Wounds highlights EscharEx®’s superior clinical performance and comparable safety profile to SANTYL®
YAVNE, Israel, May 13, 2025 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a global leader in next-generation enzymatic therapeutics for tissue repair, today announced the publication of a peer-reviewed post hoc analysis in Wounds. The analysis is based on data from the Company’s Phase II ChronEx clinical trial in patients with venous leg ulcers (VLUs) evaluating the efficacy and safety of EscharEx® compared with collagenase ointment (SANTYL®), the only FDA-cleared enzymatic debridement agent commercially available for the treatment of dermal ulcers.
The article, titled “Bromelain-Based Debridement Versus Collagenase Ointment Debridement of Venous Leg Ulcers: Post Hoc Analysis of the ChronEx Trial,” appears in the April 2025 edition of Wounds (Index 2025;37(4):166–173) and compares outcomes in a subgroup of patients from the non-surgical standard of care arm treated with SANTYL (n=8) to those treated with EscharEx (n=46).
“These new findings are consistent with my prior experience using EscharEx in clinical trials and SANTYL in clinical practice,” said Dr. Cyaandi Dove, DPM, of the University of Texas Health Science Center at San Antonio and co-author of the publication. “Compared to SANTYL, EscharEx achieved faster and more effective debridement and promoted healthier granulation tissue, both key to optimal wound bed preparation. EscharEx’s enzymatic formulation targets a wider range of non-viable and necrotic tissue, which may account for the favorable clinical outcomes observed.”
Key findings from the post hoc analysis include:
- Debridement Efficacy:
- Complete debridement at 2 weeks was achieved in
63% of EscharEx-treated patients, compared to0% in the SANTYL group (p = 0.001). - Median time to debridement was 9 days for EscharEx vs. not achieved for SANTYL (p = 0.023).
- Complete debridement at 2 weeks was achieved in
- Wound Bed Preparation (WBP):
- WBP—defined as complete debridement and complete granulation—was achieved by
50% of EscharEx patients in 2 weeks vs.0% with SANTYL (p = 0.015). - Over the entire study period (12 weeks),
78% of EscharEx patients achieved WBP vs.38% with SANTYL (p = 0.03). - Median time to WBP: 11 days for EscharEx; not achieved for SANTYL (p = 0.014).
- WBP—defined as complete debridement and complete granulation—was achieved by
- Wound Closure:
- Closure was achieved in
33% of EscharEx patients vs.25% with SANTYL (not statistically significant). - Among those who closed, the mean time to closure was 48 days for EscharEx vs. 76 days with SANTYL (p = 0.05).
- Closure was achieved in
- Safety and Tolerability:
- Adverse event rates and applicational pain were similar between groups.
- Deep wound infection, assessed using recognized clinical criteria, occurred in
11% of EscharEx patients compared to38% in the SANTYL group.
About EscharEx®
EscharEx® 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 Ltd.
MediWound Ltd. (Nasdaq: MDWD) is a global biotechnology company focused on developing and commercializing enzymatic therapies for non-surgical tissue repair. The company’s FDA-approved biologic, NexoBrid®, 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®, 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.
For more information, visit www.mediwound.com and follow us on LinkedIn.
Cautionary Note Regarding Forward-Looking Statements
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 “anticipates,” “intends,” “estimates,” “plans,” “expects,” “continues,” “believe,” “guidance,” “outlook,” “target,” “future,” “potential,” “goals” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “could,” “may,” 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®. 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’s annual report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission (“SEC”) 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’s 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.
| MediWound Contacts: Hani Luxenburg Chief Financial Officer MediWound Ltd. ir@mediwound.com | Daniel Ferry Managing Director LifeSci Advisors, LLC daniel@lifesciadvisors.com |
Media Contact: Ellie Hanson FINN Partners for MediWound ellie.hanson@finnpartners.com 929-588-2008 |
FAQ
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