Drugs / EscharEx
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05157763 | Jun 2021 → May 2022 overdue | nodular basal cell carcinoma, superficial multifocal basal cell carcinoma | MediWound Ltd | Recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT04817228 | Apr 2021 → May 2022 | ulcer of lower limbs | MediWound Ltd | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 2 | NCT03588130 Comparator | Dec 2019 → Dec 2021 | ulcer of lower limbs | MediWound Ltd | Completed | No outcome recorded |
| Phase 2 | NCT02020746 Comparator | Jul 2014 → Dec 2017 | ulcer of lower limbs | MediWound Ltd | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 21
| Date | Issuer | Release |
|---|---|---|
| 2026-09-14 | MediWound Ltd | Results Independent DSMB Recommends MediWound’s EscharEx® Phase III VALUE Study Continue Without Modification mediwound.com ↗
Following its review, the DSMB did not identify any safety concerns and recommended that the study continue as planned without modification. |
| 2026-04-07 | MediWound Ltd | Results MediWound to Present New EscharEx® Data at Leading Wound Care Conferences mediwound.com ↗
A new preclinical mechanistic study demonstrated superior debridement with EscharEx versus SANTYL across multiple non-viable tissue components, while gene expression analysis revealed that EscharEx specifically activates molecular pathways that support wound healing. |
| 2025-08-13 | MediWound Ltd | Results MediWound Announces New EscharEx® Phase II Data Demonstrating Strong Link Between Wound Bed Preparation and Wound Closure in Venous Leg Ulcers mediwound.com ↗
The publication presents data demonstrating a strong correlation between wound bed preparation (WBP) and wound closure in patients with chronic venous leg ulcers (VLUs). |
| 2025-05-13 | MediWound Ltd | Results MediWound Announces Publication of Phase II EscharEx® Data Demonstrating Superiority Over Collagenase in Venous Leg Ulcers mediwound.com ↗
Compared to SANTYL, EscharEx achieved faster and more effective debridement and promoted healthier granulation tissue, both key to optimal wound bed preparation. |
| 2024-07-29 | MediWound Ltd | Results MediWound Announces Publication of the EscharEx® Phase II ChronEx Study Results for Venous Leg Ulcers mediwound.com ↗
The significant superiority of EscharEx over the current non-surgical standard of care in achieving optimal wound bed preparation could dramatically enhance healing outcomes and provide a viable alternative to surgical debridement. |
| 2024-04-25 | MediWound Ltd | Results MediWound to Present New Data from EscharEx® Phase II Studies at Three Leading Wound Care Conferences mediwound.com ↗
These data indicate that EscharEx could substantially improve wound care for patients with debilitating chronic wounds, providing significant benefits over the current standard of care. |
| 2024-02-12 | MediWound Ltd | Results MediWound Announces Positive Results in Head-to-Head Comparison of EscharEx® vs. SANTYL® within the ChronEx Phase II Randomized Controlled Study mediwound.com ↗ |
| 2023-12-21 | MediWound Ltd | Results MediWound Announces Peer-Reviewed Publication of EscharEx® Mechanism of Action Study Assessing Its Effects on Biofilm and Microbial Loads mediwound.com ↗
Results show that EscharEx not only effectively debrides wounds, but also reduces biofilm and bacterial load in both VLUs and DFUs. |
| 2023-07-03 | MediWound Ltd | Regulatory MediWound Receives Positive Scientific Advice from European Medicine Agency (EMA) on EscharEx Phase III Study Design mediwound.com ↗
The CHMP notified the company that it concurs with the overall design of the proposed study, including its objectives, choice of study arms, patient population, inclusion/exclusion criteria, standardization of treatment, proposed primary, secondary, and safety endpoints and study duration. |
| 2022-11-09 | MediWound Ltd | Results MediWound’s EscharEx Featured in Paper as a Potential Paradigm Shift Towards Non-Surgical Wound Bed Preparation in DFUs mediwound.com ↗
Findings in the paper show EscharEx to be safe and effective, with over 50% of the patients achieving complete debridement within a week, and leaving the wounds with healthy granulation tissue. |
| 2022-10-18 | MediWound Ltd | Results MediWound's EscharEx® Featured in Oral and Poster Presentations at the Symposium on Advanced Wound Care (SAWC) Fall 2022 mediwound.com ↗
The data demonstrated EscharEx to be significantly better than gel vehicle and the non-surgical standard of care across multiple measures including incidence of complete debridement, time to achieve complete debridement and granulation tissue formation. |
| 2022-07-07 | MediWound Ltd | Results MediWound Announces Positive Results from its U.S. Phase 2 Pharmacology Study of EscharEx for Debridement of Lower Leg Ulcers mediwound.com ↗
Seventy percent of patients achieved complete debridement during the course of treatment within up to 8 applications. |
| 2022-05-12 | MediWound Ltd | Results MediWound Announces Positive Results from Its U.S. Phase 2 Trial of EscharEx for Debridement of Chronic Wounds mediwound.com ↗
MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced positive results from its U.S. Phase 2 clinical study of EscharEx ® for the debridement of venous leg ulcers (VLUs). |
| 2022-04-12 | MediWound Ltd | Results MediWound's EscharEx Highlighted in Poster and Oral Presentation at the Symposium on Advanced Wound Care (SAWC) Spring 2022 mediwound.com ↗
The poster entitled: “ Results from an Ongoing Open Phase 2 Study Assessing the Safety, Efficacy and Pharmacological Effects of Bromelain-based Enzymatic Debridement on Biofilm , Microbial loads and Cytokines in patients with DFU and VLU, ” featured data from an ongoing Phase 2 study that showed EscharEx to debride wounds and promote wound area reduction, while reducing biofilm and bacterial bioburden safely and effectively. |
| 2022-01-24 | MediWound Ltd | Results MediWound Announces Positive Topline Results From Its U.S. Phase 2 Trial of EscharEx for Debridement of Chronic Wounds mediwound.com ↗
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. |
| 2021-12-20 | MediWound Ltd | Results MediWound Announces Positive Initial Data from its U.S. Phase 2 Pharmacology Study of EscharEx Showing Effective and Rapid Debridement in Chronic and Hard to Heal Wounds mediwound.com ↗
Based on the data generated to date, following treatment of seven patients with either diabetic foot ulcers (DFU’s) or venous leg ulcers (VLU’s), EscharEx demonstrated safe and effective debridement of lower leg ulcer within a few daily applications. |
| 2021-10-04 | MediWound Ltd | Results MediWound Announces Peer-Reviewed Publication of EscharEx In-Vivo Head-to-Head Comparator Study in the Journal of Wound Care mediwound.com ↗
Study results demonstrated that EscharEx treatment was more effective than the commercially available collagenase agent in debriding eschars in this novel porcine wound model. |
| 2021-07-28 | MediWound Ltd | Results MediWound Announces Positive Outcome of Interim Assessment for its EscharEx U.S. Phase 2 Adaptive Design Study mediwound.com ↗
In addition, the IDMC reviewed the data of all subjects treated and no safety concerns were identified in the study population. |
| 2021-07-09 | MediWound Ltd | Results MediWound Announces Peer-Reviewed Paper Detailing EscharEx Phase 2 Randomized Control Trial Results Published in the Online Wound Repair and Regeneration Journal mediwound.com ↗
today announced that a peer-reviewed publication, detailing the results of a phase 2 randomized control trial of its wound debriding product candidate EscharEx ® , has been published in the Wound Repair and Regeneration Journal . |
| 2020-12-21 | MediWound Ltd | Results Successful Completion of In-Vivo Head-to-Head Comparator Study of EscharEx versus a Commercial Enzymatic Debridement Agent mediwound.com ↗
The study concluded that EscharEx treatment was more effective than the commercially available collagenase agent in removing eschars in this model. |
| 2017-09-01 | MediWound Ltd | Results MediWound Successfully Completes Second Cohort of EscharEx® Phase 2 Study mediwound.com ↗
MediWound Ltd. (Nasdaq:MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, reports positive top-line results from the second cohort of the Company's Phase 2 clinical trial evaluating EscharEx ® for debridement of dead or damaged tissue in diabetic foot ulcers (DFU) and venous leg ulcers (VLU). |
All press releases naming this drug 42 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | EscharEx | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03588130 ↗ |
| Known as | EX-02 | “Previous studies have shown positive initial results with EscharEx® (EX-02 formulation), a Bromelain-based enzymatic debridement agent in development for chronic wounds.” PMID 39763591 ↗ Jul 20241“The powder of EX-02 (8.1 g in each unit) should be reconstituted with 20 g sterile water for injection (WFI) to obtain 5% EX-02.” NCT04817228 ↗ |
| Modality | Protein / enzyme biologic | “a Bromelain-based enzymatic debridement agent” PMID 39763591 ↗ Jul 2024 |
| Route | Topical | “topically applied” NCT04817228 ↗ |