MediWound Ltd (Nasdaq: MDWD), a biopharmaceutical company developing enzymatic treatments for wound care, is advancing its investigational drug EscharEx through a Phase 3 clinical trial known as the VALUE study, which evaluates the drug's ability to prepare chronic wounds for active closure in patients with venous leg ulcers. The trial features two co-primary endpoints — complete debridement and facilitation of wound closure — a design that reflects a broader industry discussion about appropriate clinical trial endpoints for wound care therapies. The company said in September that it expected enrollment completion and an interim sample-size reassessment by the end of the first quarter of 2027. This update was distributed via FinanceWire (FNEWS) on 3 November 2026.

Key Points

  • MediWound Ltd (Nasdaq: MDWD), covered under FinanceWire reference FNEWS
  • EscharEx Phase 3 VALUE study uses co-primary endpoints of complete debridement and facilitation of wound closure in venous leg ulcer patients
  • Enrollment completion and interim sample-size reassessment expected by end of Q1 2027; an independent safety review recommended the study continue without modification
  • Investors should watch the topline readout timing and whether the co-primary endpoint design supports a regulatory pathway for EscharEx

EscharEx VALUE Study Design Separates Debridement From Spontaneous Closure in Venous Leg Ulcer Patients

MediWound's VALUE study compares EscharEx, a biologic enzymatic debridement drug, against placebo in patients with venous leg ulcers. Patients whose wounds achieve complete debridement and full granulation tissue coverage then proceed to active wound closure using either an autograft of their own skin or a placental-derived tissue graft, with EpiFix identified in trial materials as the allograft option. Active closure is described as mandatory once the wound bed is adequately prepared, a protocol-directed approach that may reduce variability in the later stages of healing and make any benefit from wound preparation more detectable in the closure endpoint.

FDA's August 2026 Public Meeting on Chronic Wounds Signals Sustained Regulatory Engagement With the Sector

An FDA public meeting held on 25 August brought together patients, care partners, clinicians, researchers and medical product developers to discuss the daily burden of nonhealing chronic wounds and treatment experiences. The announcement describes this as an encouraging sign of sustained regulatory attention to an underserved therapeutic area. A 2024 Wound Care Collaborative Community consensus, arising from a summit of clinicians, industry and academic experts, had previously described complete wound closure as a very high bar for developers and recommended carefully designed alternative endpoints when complete closure is unattainable.

Eight Major Wound Care Companies Have Joined the VALUE Study Through Research Collaborations

MediWound has stated that Medline, Mölnlycke, Coloplast/Kerecis, Solventum, Convatec, Essity, B. Braun and MiMedx have each joined the EscharEx development programme through research collaborations. The company describes this group as including all the major advanced wound care companies relevant to the programme. An independent Data Safety Monitoring Board has recommended the VALUE study continue without modification following a separate safety review, providing an additional measure of external validation for the trial's conduct ahead of the anticipated Q1 2027 enrollment completion milestone.

MediWound Also Holds a US Government Award for NexoBrid Formulation Development

Separate from the VALUE study, MediWound has received an additional award of $3.3 million from the US Department of War to advance a room-temperature-stable formulation of NexoBrid, another product in its portfolio. This award indicates the company maintains a second active development programme alongside EscharEx. The announcement notes that MediWound is a paid subscriber to Wall Street Wire's Market Discovery Program, and readers are directed to the company's public filings on SEC EDGAR for applicable risk factors and forward-looking statement disclosures.