Periodic Reporting for period 1 - ESXDFU (REVOLUTIONIZING DFU TREATMENT: ESCHAREX - A GAME-CHANGING SOLUTION)
Période du rapport: 2024-12-01 au 2025-11-30
Diabetic Foot Ulcers (DFUs) are among the most severe complications of diabetes, affecting millions worldwide and imposing a major and growing burden on health systems. These chronic wounds often do not progress through normal healing stages, leading to prolonged morbidity, infections, hospitalizations, and an increased risk of lower-limb amputation. Up to one in four people with diabetes will develop a foot ulcer, making DFUs a significant public health challenge with substantial economic impact.
Effective debridement is a critical first step in wound management. Sharp debridement, the current standard of care, requires trained specialists and is often impractical in outpatient settings. Existing non-surgical options offer variable efficacy or slow action. There is therefore a clear need for a safe, efficient, and accessible debridement solution.
The project addresses this need through the development and clinical validation of EscharEx, a novel plant-derived enzymatic debridement agent designed to rapidly and safely remove necrotic tissue. Its aim is to support earlier wound progression, reduce complications, and improve the likelihood of healing, ultimately enhancing patient quality of life and reducing healthcare costs.
The project objective is to generate the clinical and regulatory evidence required to progress EscharEx toward market approval. This includes development of a scientifically robust clinical protocol, regulatory interactions, and preparation of the Investigational Medicinal Product Dossier (IMPD). The expected impact is significant, supporting improved access to effective wound care and contributing to EU priorities in chronic disease management and prevention of avoidable amputations.
Effective debridement is a critical first step in wound management. Sharp debridement, the current standard of care, requires trained specialists and is often impractical in outpatient settings. Existing non-surgical options offer variable efficacy or slow action. There is therefore a clear need for a safe, efficient, and accessible debridement solution.
The project addresses this need through the development and clinical validation of EscharEx, a novel plant-derived enzymatic debridement agent designed to rapidly and safely remove necrotic tissue. Its aim is to support earlier wound progression, reduce complications, and improve the likelihood of healing, ultimately enhancing patient quality of life and reducing healthcare costs.
The project objective is to generate the clinical and regulatory evidence required to progress EscharEx toward market approval. This includes development of a scientifically robust clinical protocol, regulatory interactions, and preparation of the Investigational Medicinal Product Dossier (IMPD). The expected impact is significant, supporting improved access to effective wound care and contributing to EU priorities in chronic disease management and prevention of avoidable amputations.
The project progressed the scientific, regulatory, and analytical foundations for the Phase 2 DFU study, with 14 out of 18 project deliverables have been successfully completed.
The randomized, double-blind, placebo-controlled protocol (MW2025-01-01) was finalized, defining complete debridement as the primary endpoint and including secondary measures such as time to debridement, granulation, wound-bed readiness, safety, pain, and infection, with standardized care across both arms.
The phase 2 study protocol was submitted to FDA and EMA for review. Both agencies supported the two-arm, placebo-controlled design without a standard-of-care arm, and provided recommendations on patient characteristics, stratification, and endpoint interpretation.
Preparations for the Investigational Medicinal Product Dossier (IMPD) are ongoing, with submission scheduled for mid-2026. Analytical activities, including release and stability testing, new packaging design, and clinical batch manufacturing, have been completed.
An EscharEx manuscript has been accepted for peer-reviewed publication August 2025. EscharEx was also presented at multiple international conferences e.g. DFcon, SAWC, strengthening scientific visibility and stakeholder engagement.
European clinical site start-up activities are underway, covering feasibility assessments, regulatory submissions, site activation, ethics approvals, investigator training, and supporting systems for electronic data capture, safety reporting, and study-supply management. Completion is expected by November 2026, enabling trial initiation.
The randomized, double-blind, placebo-controlled protocol (MW2025-01-01) was finalized, defining complete debridement as the primary endpoint and including secondary measures such as time to debridement, granulation, wound-bed readiness, safety, pain, and infection, with standardized care across both arms.
The phase 2 study protocol was submitted to FDA and EMA for review. Both agencies supported the two-arm, placebo-controlled design without a standard-of-care arm, and provided recommendations on patient characteristics, stratification, and endpoint interpretation.
Preparations for the Investigational Medicinal Product Dossier (IMPD) are ongoing, with submission scheduled for mid-2026. Analytical activities, including release and stability testing, new packaging design, and clinical batch manufacturing, have been completed.
An EscharEx manuscript has been accepted for peer-reviewed publication August 2025. EscharEx was also presented at multiple international conferences e.g. DFcon, SAWC, strengthening scientific visibility and stakeholder engagement.
European clinical site start-up activities are underway, covering feasibility assessments, regulatory submissions, site activation, ethics approvals, investigator training, and supporting systems for electronic data capture, safety reporting, and study-supply management. Completion is expected by November 2026, enabling trial initiation.
DFUs rank among the top ten global diseases in terms of patient and societal burden, affecting 25% of Europe’s 60 million diabetic patients. Current methods for debridement are either surgical, resource-intensive, or insufficiently effective, contributing to delayed healing and higher rates of complications, hospitalizations, and amputations.
EscharEx represents an advancement beyond current options by providing a non-surgical, efficient, and safe method for enzymatic debridement. Its ability to promote non-surgical removal of necrotic tissue rapidly and consistently positions it as a promising solution for improving wound-care outcomes. The project’s results support continued clinical development and demonstrate potential to reduce healthcare expenditures linked to chronic wound management.
These efforts will help transform EscharEx into a widely accessible therapy addressing a major unmet medical need.
EscharEx represents an advancement beyond current options by providing a non-surgical, efficient, and safe method for enzymatic debridement. Its ability to promote non-surgical removal of necrotic tissue rapidly and consistently positions it as a promising solution for improving wound-care outcomes. The project’s results support continued clinical development and demonstrate potential to reduce healthcare expenditures linked to chronic wound management.
These efforts will help transform EscharEx into a widely accessible therapy addressing a major unmet medical need.