Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as EscharEx (5% EX-02 formulation), EscharEx (EX-02 formulation), EscharEx (EX-03), EX-03, EscharEx 5%
EscharEx · 7 trials · 10 indications
counting events of complete debridement
counting events of complete wound closure until completion of weekly visits
Cmax (maximal observed serum concentration),
Incidence and severity of systemic and local adverse events (AEs),
The endpoint will assess number of patients, in each arm, with reported local (target wound related) AEs
Number of patients with Clinically significant changes in vital signs
The outcome will assess time to reaching complete wound closure
The outcome will assess number of patients reaching complete wound closure
Incidence of complete debridement assessed clinically
Time to complete debridement assessed clinically
Wound healing biomarkers (MMP2, MMP9, HNE, PDGF, IL8, TNFR1) distribution in wound fluid will be compared before and after completion of treatment
Biofilm presence in wound will be compared before and after completion of treatment, using punch biopsy from wound
The clinical assessor will define complete debridement, after each application during the daily visits period
All adverse events (AEs) will be listed. Adverse events records will include notification whether the AE is local and occurs near or in the target lesion. The AEs will be listed as counts and percentages by System Organ Class (SOC), Preferred Term (PT), severity, and time of onset. Serious Adverse Events will be analyzed in the same way as AEs
Assessed pre 2nd, pre 5th application and post last application
Assesed pre 2nd, pre 5th application and post last application compared with pre 1st application
This proportion will be calculated, together with its 95% confidence interval based on the binomial distribution.
This will be assessed over the entire course of the treatment and will be calculated, together with its 95% confidence interval based on the binomial distribution
| Arm | Type | Description |
|---|---|---|
| EscharEx (EX-03) | ACTIVE_COMPARATOR | EX-03 is the code name of the third generation of EscharEx investigational medicinal product (IMP) formulation. A sterile lyophilized powder containing a concentrate of proteolytic enzymes enriched in bromelain (anacaulase-bcdb ), the active pharmaceutical ingredient (API), that is blended with excipients. EX-03 5% powder, should be diluted with Water for Injection (WFI) prior usage. |
| Placebo | PLACEBO_COMPARATOR | Placebo (Gel Vehicle, hydrogel) contains the same excipients as in EX-03, without the API. Placebo powder, should be diluted with Water for Injection (WFI) prior usage. |
| Collagenase | OTHER | Non-surgical standard of care treatment arm |
| EX-02 Gel | EXPERIMENTAL | 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. EX-02 5% gel will be topically applied on a wound surface of up to 80 cm2 for 24±3 hours, up to 8 consecutive applications |
| EscharEx (5% EX-02 formulation) | ACTIVE_COMPARATOR | Debridement will be performed with 5% EX-02 for 24±3 hours, up to 8 applications |
| Gel Vehicle | PLACEBO_COMPARATOR | Debridement will be performed with Gel vehicle for 24±3 hours, up to 8 applications |
| Non-surgical standard of care (NSSOC) | ACTIVE_COMPARATOR | Debridement will be performed with NSSOC (Santyl or commercially approved Hydrogel) per routine procedures, until complete debridement is achieved |
| EscharEx | ACTIVE_COMPARATOR | Enzymatic debridement |
| EscharEx 5% | EXPERIMENTAL | The powder of EX-02 (4 g per vial) should be reconstituted with 10 ml water for injection (WFI) to obtain 5% EX-02 gel. The EX-02 powder and the WFI are to be mixed up to 15 min prior to use. EX-02 5% gel will be topically applied in a thick layer of 2-3 mm on the lesion surface including margin of 5-10 mm for 8-12 hours (preferable over-night) and covered with an occlusive dressing. A new vial should be used for each application. Each patient will be treated with 7 applications. |
| Name | Type | Description |
|---|---|---|
| EscharEx (EX-03) | DRUG | a sterile lyophilized powder containing a concentrate of proteolytic enzymes enriched in bromelain (anacaulase-bcdb). The powder and sterile water are mixed to form a gel prior to application on the wound area. |
| Placebo (Gel vehicle) | DRUG | A sterile powder containing excipients only (no proteolytic enzymes). The powder and sterile water are mixed to form a gel prior to application on the wound area |
| EX-03 | DRUG | a sterile lyophilized powder containing a concentrate of proteolytic enzymes enriched in bromelain (anacaulase-bcdb). The powder and sterile water are mixed to form a gel prior to application on the w |
| EscharEx (EX-02 formulation) | DRUG | EscharEx (EX-02 formulation) gel is topically applied on a wound surface of up to 80 cm2 , up to 8 consecutive applications or until a complete debridement is achieved, whichever occurs first. |
| EscharEx (5% EX-02 formulation) | DRUG | Active arm |
| Gel Vehicle | DRUG | Control arm |
| Non-surgical standard of care (NSSOC) | DRUG | Santyl (Enzymatic debridement) or commercially approved Hydrogel |
| EscharEx | DRUG | - |
| EscharEx 5% (EX-02 formulation) | DRUG | EX-02 5% will be topically applied in a thick layer of 2-3 mm on the lesion surface for 8-12 hours including 5-10 mm margins and covered with an occlusive dressing. A new vial should be used for each application. Each patient will be treated with 7 applications. |
Inclusion Criteria: 1. Men or women, older than 18 years of age, 2. Patients with a VLU (determined by medical history, physical examination, and a documented ultrasound scan demonstrating venous insufficiency), 3. Wound is present for at least 4 weeks but no longer than 18 months, 4. The adherent ...
EscharEx is an investigational small molecule developed for debridement of hard to heal wounds, including venous leg ulcers. It is also being studied in superficial and nodular basal cell carcinoma. MediWound Ltd. is developing the drug across these wound care and dermatology indications.
EscharEx is developed by MediWound Ltd., which trades on the Nasdaq under the ticker MDWD. The company is the sponsor of the clinical program evaluating the drug in venous leg ulcers and basal cell carcinoma.
EscharEx is in Phase 2 development overall, with a Phase 3 trial in venous leg ulcers now recruiting. The program includes four trials in total: two completed and two active. A Phase 1 study in basal cell carcinoma and Phase 2 studies in venous leg ulcers are also underway.
EscharEx trials include NCT06568627, a Phase 3 double blind study of debridement in venous leg ulcers, and NCT05157763, a Phase 1 study in basal cell carcinoma. Phase 2 studies NCT07692178 and NCT06690177 evaluate the EX-03 formulation in venous leg ulcers. Total enrollment across the program is 368 participants.
Yes. EscharEx is also known as the EX-03 formulation and the EX-02 formulation, and appears in trial records as EscharEx (EX-03), EscharEx (EX-02), and EscharEx 5%. The EX-03 formulation is used in the venous leg ulcer studies, while EX-02 was studied in basal cell carcinoma.
EscharEx is investigational and has not been approved for marketing. It remains in clinical development, with a Phase 3 trial in venous leg ulcers recruiting and Phase 1 and Phase 2 studies ongoing. MediWound Ltd. is the sponsor of these trials.