MediWound's EscharEx Outperforms SANTYL in Healing Venous Leg Ulcers, Study Shows

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 to 0% in the SANTYL group (p = 0.001).
  • Median time to debridement was 9 days for EscharEx vs. not achieved for SANTYL (p = 0.023).
• 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).
• 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).
• 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 to 38% in the SANTYL group.