Next-gen of Wound Care
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 three 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
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.
In three 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 US phase 2 trial were 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.
Positive results were received from the U.S. prospective, open-label, single-arm, Phase 2 pharmacology clinical study of EscharEx® for the debridement of lower leg ulcers.
The study was designed to evaluate the clinical performance, safety and pharmacology effect of EscharEx in debridement of venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs). Seventy percent of patients achieved complete debridement during the course of treatment within up to 8 applications. On average, complete debridement was achieved after 3.9 applications of EscharEx. Additionally, an average reduction of 35% in wound size was achieved by the end of the 2-week follow-up period. In all patients that were positive for biofilm at baseline, the biofilm was reduced substantially to single individual microorganisms or completely removed by the end of treatment. Seven patients had positive red fluorescence (indicative of bacteria) at baseline and average red fluorescence was reduced from 1.69 cm2 pre-treatment to 0.60 cm2 post treatment. Biomarker analysis from wound fluid is on-going and safety data shows that EscharEx is safe and well-tolerated.
The safety profile was comparable to hydrogel vehicle and no deleterious effect on wound healing was observed.
A recent Phase 2 clinical study of EscharEx® for the debridement of venous leg ulcers (VLUs) also received positive results. This study also met its primary endpoint, its key secondary endpoints with high degree of statistical significance, as well as its wound closure safety measurements demonstrating that patients treated with EscharEx had a statistically significant higher incidence of complete debridement during the 14-day measurement period within up to 8 applications compared to gel vehicle (EscharEx: 63% (29/46) vs. gel vehicle: 30% (13/43), p-value=0.004). EscharEx efficacy superiority remained statistically significant compared to gel vehicle after adjusting for pre-specified covariates ascribed to patient baseline characteristics, wound size, wound age and regions.
The study met key secondary and exploratory endpoints. Patients treated with EscharEx had a statistically significant higher incidence of complete debridement, during the same 14-day measurement period, compared to patients treated by non-surgical standard-of-care (“NSSOC”) (EscharEx: 63% (29/46) vs. NSSOC: 13% (4/30)) and the time to achieve complete debridement was significantly shorter. Estimated median time to complete debridement, was 9 days for patients treated with EscharEx and 59 days for patients treated with NSSOC (p-value=0.016). On average, complete debridement was achieved after 3.6 applications of EscharEx compared to 12.8 applications with NSSOC. Patients treated with EscharEx demonstrated significantly higher incidence of at least 75% granulation tissue at the end of the treatment period compared to gel vehicle (p-value <0.0001). Favorable trends were observed in wound area reduction and reduction of pain compared to gel vehicle.
In addition, the study showed that EscharEx was safe and well tolerated, and the overall safety was comparable between the arms as assessed by the data safety monitoring board. Importantly, there were no observed deleterious effects on wound closure and no material differences in reported adverse events. Estimated time to complete wound closure was 64 days for patients treated with EscharEx compared to 78 days for patients treated with NSSOC.
A meeting with the FDA to discuss the Phase 3 pivotal study design is targeted for the fourth quarter of calendar year 2022.