MediWound Announces Positive Results in Head-to-Head Comparison of EscharEx vs. SANTYL within the ChronEx Phase II Randomized Controlled Study - Seite 2

Dr. Robert J. Snyder, Chief Medical Officer of MediWound added, “Complete debridement and complete granulation are key components of wound bed preparation, a critical step in the transition of a chronic wound from an abnormal, disrupted healing process to a normal healing process. These results further support the potential superiority of EscharEx compared with SANTYL in both the percentage of wounds achieving these critical steps, as well as the timeframe in which they are achieved. These significant differences could have a profound impact on wound healing, prevention of complications, and reduction in disease burden.”

The data is scheduled for presentation in May 2024 at three leading annual congresses dedicated to advanced wound care: The Wound Healing Society (WHS), the Symposium on Advanced Wound Care (SAWC), and the European Wound Management Association (EWMA).

About the ChronEx study

The ChronEx study was a Phase II multicenter, prospective, randomized, placebo controlled, adaptive design study that evaluated the safety and efficacy of a bromelain-based enzymatic debridement agent in debridement of Venous Leg Ulcers (VLUs).

In the ChronEx study, patients with chronic VLU were randomized (3:3:2 ratio) to daily treatment with EscharEx, placebo, or non-surgical standard of care (SOC), respectively, for up to 2 weeks or until reaching complete debridement and then treated with non-surgical SOC for 12 weeks. The non-surgical SOC arm included SANTYL, hydrogels, medical grade honey, and non-active dressings.

About EscharEx

EscharEx is a bioactive, multimodal debridement therapy for the treatment of chronic and other hard-to-heal wounds, currently in the advanced stages of clinical development. It is a concentrate of proteolytic enzymes enriched in bromelain for topical, easy to use daily applications. In several Phase II trials, EscharEx was shown to be safe, well-tolerated, and demonstrated its efficacy in debridement and promotion of granulation tissue in various hard-to-heal wounds, with only a few daily applications. EscharEx’s mechanism of action is mediated by proteolytic enzymes that cleave to and remove the necrotic tissue preparing the wound bed for healing. Phase III study in patients with VLU, is planned to start in the second half of 2024.