MediWound Reports Final Positive Results of Phase 2 Clinical Trial of EscharEx for the Debridement of Chronic and Hard-to-Heal Wounds
YAVNE,
EscharEx is based on the same propriety proteolytic enzyme technology used in MediWound's NexoBrid®, which is approved and commercially available in
Study Design
The prospective, randomized, controlled, assessor-blinded Phase 2 trial of 73 patients was conducted at 15 clinical sites in
The single, statistically-powered primary endpoint of the trial was incidence of complete debridement (non-viable tissue removal) at the end of the debridement period (up to 10 treatment days). Secondary endpoints assessed several parameters including time to debridement, wound healing and other efficacy and safety parameters. In addition, the trial included subgroup analyses for each etiology.
The objectives of the study were to (1) evaluate the efficacy of EscharEx in debriding chronic wounds, (2) to assess its safety and lack of deleterious effect on wound healing and (3) to further analyze these effects in different etiologies to guide the design of future pivotal studies. All three objectives were achieved.
1 Hydrogel is not a true sham placebo as it is a common and widely used treatment for the debridement of chronic wounds.
Study Results
Based on the Final Clinical Study Report, the Phase 2 trial met its statistically-powered primary endpoint, the incidence of complete debridement at the end of the debridement period. Patients treated with EscharEx demonstrated a higher incidence of complete debridement (55% or 27/49) compared with patients treated with the hydrogel vehicle (29% or 7/24) with p=0.047.
Predefined sub-group analyses showed that 50% of patients with DFUs treated with EscharEx (8/16) achieved complete debridement at the end of the debridement period compared with 14% of patients with DFUs treated with hydrogel vehicle (1/7). In addition, 63% of patients with VLUs treated with EscharEx (10/16) achieved complete debridement at the end of the debridement period compared with 25% of patients with VLUs treated with hydrogel vehicle (2/8). Post-hoc analysis showed that 56.3% of patients with DFU or VLU in the EscharEx group had complete debridement at the end of the debridement period compared with 20.0% in hydrogel vehicle group (p=0.028).
The study included secondary endpoints that provide further insight on a number of efficacy and safety parameters. The secondary endpoint of time to complete debridement demonstrated a clear trend (p=0.075) that strongly suggests that not only is there a difference in the incidence of debridement, as confirmed by the primary endpoint, but that debridement occurred earlier in the group treated by EscharEx. The advantage in time to complete debridement was corroborated by the statistically significant post hoc result in the subgroup of patients with DFUs or VLUs that were treated with EscharEx (p=0.024).
Post hoc analysis shows that of patients that achieved complete debridement in the EscharEx group, 93% (25/27) completed the debridement within 7 daily applications (4-5 applications on average).
The overall patient demographics were comparable across both arms. No deleterious effect on wound healing was observed and no material differences were found in reported adverse events. The overall safety was comparable between the arms.
These favorable results were achieved despite the fact that the average wound age in the EscharEx group was more than double that of the hydrogel vehicle group (72.8 weeks vs. 30.8 weeks) and the average wound size was larger in the EscharEx group (33.6 cm2) vs. the hydrogel vehicle group (25.8 cm2).
The Company will share these final data with the
Management Commentary
"We completed the study follow-up period and are happy to reaffirm the previously reported positive results. These final results reinforce our belief that EscharEx has the potential to become a first-in-class topical debridement treatment for chronic wounds," stated
"As reported previously, following the successful completion of this first cohort of the Phase 2 study, we initiated a second cohort of 32 patients to demonstrate safety over extended periods of application to further support product application periods of 24 to 48 hours, which we believe will enhance convenience and compliance. Patients with DFUs and VLUs are randomized to either EscharEx or gel vehicle treatment at a ratio of 2:1. We expect to complete the second cohort of the Phase 2 study and to report top-line data in mid-2017," concluded
About Chronic and Other Hard-to-Heal Wounds and Eschar
Chronic and other hard-to-heal wounds are caused by impairment in the biochemical and cellular healing processes due to local or systemic conditions, and generally can take several weeks or longer to heal.
In each of the various wound types, the presence of the eschar is a frequent cause of wound chronification and the removal of eschar is a key step to commence healing. If not effectively treated, these wounds can lead to severe complications including further infection, osteomyelitis, fasciitis, amputation and increased mortality.
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Cautionary Note Regarding Forward-Looking Statements
This release includes forward-looking statements within the meaning of Section 27A of the
Contacts:
Chief Financial & Operations Officer
ir@mediwound.co.il
Senior Vice President
LHA
212-838-3777
afields@lhai.com
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