NexoBrid® Clinical Efficacy
The safety and efficacy of NexoBrid were evaluated in two clinical studies.1
NexoBrid achieved a significantly higher incidence of ≥95% eschar removal vs gel vehicle1
≥95% Eschar Removal with NexoBrid vs Gel Vehicle
- 93% of subjects treated with NexoBrid achieved ≥95% eschar removal vs 4% with gel vehicle1
Median time to ≥95% eschar removal was significantly shorter with NexoBrid vs SOC1*
Median Time to ≥95% Eschar Removal
NexoBrid resulted in a significantly lower incidence of excision for eschar removal vs SOC1*
Incidence of Excision for Eschar Removal
- There was a 4% incidence of excision for eschar removal following treatment with NexoBrid vs 72% with SOC1
NexoBrid achieved ≥95% wound closure in 31 days vs 36 days with SOC1*||¶
Median Time to ≥95% Wound Closure
(Safety Endpoint)
*Standard of care (SOC) included a combination of surgical and non-surgical eschar removal procedures such as: tangential, minor, avulsion, Versajet, and/or dermabrasion excision per the investigators’ discretion.
†The statistical test that resulted in this p-value was Fisher’s Exact Test.
‡The statistical test that resulted in this p-value was Wilcoxon-Gehan Test.
§The statistical test that resulted in this p-value was Wald Chi-Square.
||Study 1 used Kaplan-Meier methods to estimate median time to ≥95% wound closure for all target wounds (TWs) on a subject. This was a noninferiority endpoint.
¶Subjects were not evaluated frequently enough after achieving ≥95% wound closure to adequately assess time to 100% wound closure.
Review Study 2:
NexoBrid compared to SOC1
NexoBrid resulted in a significantly lower incidence of excision for eschar removal in deep partial thickness (DPT) wounds vs SOC1*
Incidence of Excision for Eschar Removal Performed on DPT Wounds
- There was a 15% incidence of DPT wounds requiring excision for eschar removal following treatment with NexoBrid vs 63% with SOC1
NexoBrid achieved ≥95% wound closure in 33 days vs 24 days with SOC2*‡§
Median Time to ≥95% Wound Closure (Per Subject)
NexoBrid was associated with a lower percentage of wounds autografted in DPT wounds vs SOC2*
DPT Wounds Requiring Autografts
- NexoBrid resulted in a significant reduction of DPT wound autografts vs SOC (18% with NexoBrid vs 34% with SOC)2
NexoBrid was associated with a lower percentage of wound area autografted in DPT wounds vs SOC2*
DPT Wound Area Autografted
- The mean percent of DPT wound area autografted was significantly lower with NexoBrid vs SOC (8.4 ± 21.3 with NexoBrid vs 21.5 ± 34.8 with SOC)2
*Standard of care (SOC) included a combination of surgical and non-surgical eschar removal procedures such as: tangential, minor, avulsion, Versajet, and/or dermabrasion excision per the investigators’ discretion.
†The statistical test that resulted in this p-value was Logistic Regression Model.
‡Study 2 used Kaplan-Meier methods to estimate median time to ≥95% wound closure in randomized subjects.
§Subjects were not evaluated frequently enough after achieving ≥95% wound closure to adequately assess time to 100% wound closure.
||The statistical test which resulted in this p-value was the log rank test.
¶The statistical test that resulted in this p-value was the Analysis of Covariance (ANCOVA) Model.
