Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as EscharEx (EX-03), EscharEx, EscharEx 5% (EX-02 formulation)
EscharEx 5% · 1 trial · 2 indications
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 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 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: Inclusion Criteria- Patient level 1. Male or female greater than age 18, 2. Patients with one primary superficial or nodular basal cell carcinoma lesion (Histologically confirmed BCC) located on the trunk or upper extremities (not including the hands), with well-defined borders...
EscharEx is an investigational topical drug being developed for debridement of hard to heal wounds, including venous leg ulcers (VLU), diabetic lower extremity ulcers, and traumatic or post operative wounds. It is also being studied in superficial basal cell carcinoma. EscharEx is not FDA approved and remains in clinical development.
EscharEx is a small molecule drug designed to selectively remove necrotic tissue, or eschar, from wounds, a process called debridement. By breaking down dead tissue, it aims to prepare the wound bed for healing. The exact molecular target has not been disclosed.
EscharEx is being developed by MediWound Ltd., a biopharmaceutical company traded on NASDAQ under the ticker MDWD. MediWound is conducting clinical trials to evaluate the safety and efficacy of EscharEx for wound debridement indications.
EscharEx is currently in Phase 3 clinical development. A Phase 3 trial, NCT06568627, is recruiting participants to evaluate the efficacy and safety of EscharEx in debridement of venous leg ulcers. Earlier Phase 2 trials have been completed.
EscharEx has been studied in several clinical trials. Completed Phase 2 trials include NCT02020746 in hard to heal wounds, NCT03588130 in venous leg ulcers, and NCT04817228 in lower leg ulcers. A Phase 3 trial, NCT06568627, is currently recruiting for venous leg ulcer debridement.
EscharEx is also known as EscharEx (EX-03) and EscharEx 5% (EX-02 formulation). These names refer to different formulations or versions of the same investigational drug. The EX-02 formulation was evaluated in a Phase 2 trial for venous leg ulcer debridement.