Concentrate of proteolytic enzymes enriched in bromelain

Table of contents

• What is concentrate of proteolytic enzymes enriched in bromelain?
• How does concentrate of proteolytic enzymes enriched in bromelain work?
• Which conditions is concentrate of proteolytic enzymes enriched in bromelain studied for?
• How is concentrate of proteolytic enzymes enriched in bromelain given?
• What do the clinical trials show?
• Who can take part in these trials?
• What side effects are known?

What is concentrate of proteolytic enzymes enriched in bromelain?

Concentrate of proteolytic enzymes enriched in bromelain, also known by the development name EscharEx, is an investigational substance being developed as a topical treatment for wound debridement. It is a mixture of enzymes that break down proteins, with bromelain as the main active enzyme component. Bromelain is a protease enzyme derived from pineapple stems. The formulation studied in the clinical trials is a 5% EscharEx gel (EX-03 formulation) applied directly to the wound surface.^[1][2]

In the registry records, the substance is listed as an investigational product with no marketing authorisation. It is being developed for wound bed preparation in venous leg ulcers, which means removing dead tissue from the wound so that healing can proceed.

How does concentrate of proteolytic enzymes enriched in bromelain work?

EscharEx contains proteolytic enzymes, which are proteins that break down other proteins. In a wound, dead tissue (eschar) is made up largely of protein. The enzymes in EscharEx digest this dead tissue, a process called debridement. Removing dead tissue helps prepare the wound bed for healing. The clinical trials are measuring whether EscharEx can achieve complete debridement more effectively than placebo gel vehicle.^[1]

The exact molecular target of the bromelain-enriched concentrate is not described in the registry records. The mechanism is understood through its enzymatic activity on wound tissue rather than through a specific receptor or pathway.

Which conditions is concentrate of proteolytic enzymes enriched in bromelain studied for?

• Venous leg ulcer (VLU) — a chronic wound on the lower leg caused by poor blood flow in the veins. Both registered trials study EscharEx in participants with venous leg ulcers.^[1][2]

No other conditions are listed in the available trial registry data.

How is concentrate of proteolytic enzymes enriched in bromelain given?

EscharEx is given by topical application on the wound. In both trials, the dose is 3500 gm/m2 (grams per square meter) applied directly to the wound surface.^[1][2] The Phase 3 trial describes up to 8 applications during the daily visits period.^[1] The placebo is a gel vehicle applied in the same way. The Phase 2 trial also includes a non-surgical standard of care comparator arm.^[2]

What do the clinical trials show?

Two authorised trials of EscharEx are registered, both in venous leg ulcers. The larger is a Phase 3 adaptive design study (NCT06568627) with 273 participants, comparing EscharEx with placebo gel vehicle and an amnion/chorion membrane allograft.^[1] The smaller is a Phase 2 study (NCT06690177) with 45 participants, comparing EscharEx and its placebo with non-surgical standard of care.^[2]

The Phase 3 trial measures two primary outcomes: the incidence of complete debridement, assessed visually after each application during the daily visits period (up to 8 applications), and the time to complete wound closure from the start of treatment until the end of the weekly visits period.^[1]

The Phase 2 trial measures safety outcomes including the incidence and severity of local and systemic adverse events, changes in vital signs and laboratory parameters, and the incidence of discontinuation due to adverse reactions. It also measures efficacy outcomes including pain using the Numeric Pain Rating Scale (NPRS), time to complete wound closure, incidence of complete wound closure, and percent change in wound area from baseline assessed by eKare inSight imaging.^[2]

Both trials are randomised, double-blind or controlled studies. The Phase 3 trial is described as prospective, randomised, double-blind and placebo-controlled with an adaptive design. The Phase 2 trial is prospective, randomised, placebo and non-surgical standard of care controlled.

Who can take part in these trials?

The registry records identify participants with venous leg ulcers as the study population. Detailed inclusion and exclusion criteria are not provided in the available data. The Phase 3 trial enrolls 273 participants and the Phase 2 trial enrolls 45 participants.^[1][2]

What side effects are known?

The Phase 2 trial is specifically designed to measure the incidence and severity of local and systemic adverse events, changes in vital signs and clinical laboratory parameters, and discontinuations due to adverse reactions.^[2] The registry data do not report specific side effects that have occurred; these will be collected during the trials. No side effect information for EscharEx is available from the supplementary sources.