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EscharEx®
Next-gen of Wound Care
Bioactive Debridement Agent
- Indication:Debridement of Chronic and other hard-to-heal wounds
- Classification:Biological drug
- Target audience:Outpatient setting
- Development status:U.S. Phase 2 adaptive design study underway
EscharEx is a bioactive therapy for debridement of chronic and other hard-to-heal wounds is a product candidate in advanced stages of development. EscharEx, a concentrate of proteolytic enzymes enriched in bromelain, is an easy to use product candidate, for topical daily applications, which designed for the outpatient setting in accordance with the current treatment workflow and reimbursement programs. EscharEx has demonstrated in two phase 2 studies safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, with only a few daily applications.
As a rapid and effective debridement agent, EscharEx is complementary to the large number of existing advanced wound healing therapies, which require a clean wound bed in order to heal the wound.
EscharEx is a topical bioactive agent being developed for debridement of chronic and other hard-to-heal wounds, in order to fulfill an unmet medical need for a non-surgical rapid and effective debridement mean. Each year approximately 2 million patients with Venus Leg Ulcers (VLUs) and Diabetic Foot Ulcers (DFUs) are eligible for debridement in the U.S. alone.
How to Use
Topical Bioactive Debridement Agent
EscharEx is intended to be topically-applied over the wound bed for several 24-hours applications, until the necrotic tissue is removed and the wound is debrided.
The mechanism of action of EscharEx is mediated by the proteolytic enzymes that cleave and remove the necrotic tissue and prepare the wound bed for healing.
01
Wound Cleansing
02
Topical Application
03
Wound Dressing
04
Dressing Change & Re-Application
Scientific Evidence
Phase 2 Studies
In two Phase 2 studies that we conducted, EscharEx was well-tolerated and demonstrated safety and efficacy in the debridement of chronic and other hard-to-heal wounds, in a few daily applications.
The objectives of our second phase 2 trial was to assess the efficacy and safety of EscharEx in debriding chronic wounds, and to further analyze these effects in different etiologies to guide the design of future pivotal studies.
The study met its primary endpoint with statistical significance. Patients treated with EscharEx demonstrated a higher incidence of complete debridement compared with patients treated with the hydrogel vehicle, and debridement was achieved earlier.
The safety profile was comparable to hydrogel vehicle and no deleterious effect on wound healing was observed.
In the U.S, we are conducting a phase 2 adaptive design clinical study with the second generation EscharEx, for the treatment of venous leg ulcers (VLUs). The study is built on the positive data from the completed phase 2 study of the first-generation EscharEx. The study is designed to assess the safety and efficacy of EscharEx compared to gel vehicle (placebo control) and non-surgical standard-of-care (either enzymatic or autolytic debridement)
Phase 2 Study Successful Results
15
Clinical Sites
73
Number of Patients
01
Incidence of complete debridement - ITT Analysis
02
Time to complete debridement
03
Incidence of complete debridement - Post-Hoc Analysis
