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.
