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MediWound's ( MDWD ) EscharEx treatment aims to redefine care

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No new FDA-approved drugs in this category since 1965

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Trial to be conducted across 40 sites; 216 patients

By Steven Scheer

JERUSALEM, Feb 12 (Reuters) - MediWound ( MDWD ), 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.

MediWound ( MDWD ) also plans to initiate a Phase II study in 2025

comparing EscharEx to collagenase in patients with venous leg

ulcers.

MediWound ( MDWD ), 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.