Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EscharEx · 5 trials · 8 indications
counting events of complete debridement
counting events of complete wound closure until completion of weekly visits
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
| 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 |
| 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 |
| 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 | - |
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 1 year, 4. The adherent nec...