MediWound to launch Phase III trial for venous leg ulcers

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By Steven Scheer

JERUSALEM (Reuters) – MediWound, an Israeli developer of products to treat burns and wounds using non-surgical tissue repair, said on Wednesday it was starting a Phase III trial for its treatment for venous leg ulcers.

The company said its EscharEx treatment had previously demonstrated its ability to effectively and rapidly remove damaged or dead tissue from chronic wounds in multiple Phase II trials.

“With no new FDA-approved drugs in this category since 1965, EscharEx has the potential to redefine the standard of care for chronic wound debridement,” CEO Ofer Gonen said, referring to the removal of damaged tissue.

“We are confident that EscharEx will provide meaningful benefits to patients, healthcare providers, and payors alike.”

Venous leg ulcers affect about 2% of individuals aged 65 and older, with over 1.5 million new cases reported annually in the U.S., the company said.

They typically develop on the lower extremities due to chronic venous insufficiency and are characterized by large, shallow wounds that can cause severe pain, infection and disability, highlighting the need for effective treatment options, it said.

The trial’s primary objective is to evaluate the efficacy and safety of EscharEx in achieving effective removal of damaged tissue and preparing the wound bed for healing.

The trial will be randomised, double-blind and placebo-controlled, and conducted across 40 sites in the United States and Europe. It will enroll 216 patients who will undergo up to eight daily applications over two weeks, followed by 10 weeks of standardized wound management.

Interim results are planned after 65% of patients complete treatment, which is expected in mid-2026.

To support the trial, MediWound has set up research collaborations with Solventum, Mölnlycke and MIMEDX, which will provide advanced products to ensure consistent wound management across all study sites and optimize patient outcomes, it said.

MediWound also plans to initiate a Phase II study in 2025 comparing EscharEx to collagenase in patients with venous leg ulcers.

MediWound, partly backed by the Point72 hedge fund founded by New York Mets baseball team owner Steve Cohen, is also preparing for a Phase II/III clinical trial targeting diabetic foot ulcers, expected to begin in 2026.

The company’s Nasdaq-listed shares were down 1.2% at $17.05 in premarket trading. They are down 3% so far in 2025 after a 75% jump in 2024.

(Reporting by Steven Scheer; Editing by Bernadette Baum)