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NexoBrid

Phase 3

Thermal Burns | Small molecule | Other |MediWound Ltd.|Last Updated: Sep 27, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedPLACEBO_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment320
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02148705A Study to Evaluate the Efficacy and Safety of NexoBrid in Subjects With Thermal BurnsPHASE3 COMPLETED 175 — — May 27, 2015Aug 20, 2020Jul 10, 202429 United States, Belgium +6
NCT02278718A Study to Evaluate the Efficacy and Safety of NexoBrid in Children With Thermal Burns Compared the Standard of CarePHASE3 COMPLETED 145 — — May 1, 2015Dec 1, 2022Sep 27, 202436 United States, Belgium +12
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Study Endpoints
Primary Endpoints
Primary Endpoint: Number of Participants With Complete Eschar Removal.
post application (post 2 h soaking)

Comparison of NexoBrid over Gel Vehicle for eschar removal as measured by Number of Participants with complete eschar removal at the end of the topical agent soaking period by a blinded assessor.

Time to Complete Eschar Removal (in Days)
From randomization date until complete eschar removal. For NexoBrid, assessed post application (post 2 h soaking) and for SOC assessed immediately post last dressing change for non-surgical SOC arm and immediately post excision for surgical SOC arm.

Measured by a survival analysis of incidence of complete eschar removal as a function of time. Eschar removal will be measured at the end of the debridement starting from randomization date, assessed until complete eschar removal is achieved (in days)

Secondary Endpoints
Secondary Endpoint: Number of Participants With Surgical Excision Performed or Eschar Removal for NexoBrid vs SOC (FAS)
Post application (post 2 h soaking) for NexoBrid arm and immediately post surgical excision for SOC arm.
Secondary Endpoint: Comparison of Time (Days) to Complete Eschar Removal
From randomization until complete eschar removal. For NexoBrid, assessed post application (post 2 h soaking) and for SOC assessed immediately post last dressing change for non-surgical SOC arm and immediately post excision for surgical SOC arm.
Secondary Endpoint: Patient-Level Comparison of Actual Blood Loss (Volume in mL) Related to Eschar Removal for NexoBrid vs SOC (FAS)
For NexoBrid arm, blood loss during NexoBrid application until post soaking. For SOC arm, blood loss during SOC procedures, through last dressing change for non-surgical SOC arm and through excision surgery for surgical SOC arm.
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelFACTORIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NexoBrid GelEXPERIMENTALNexoBrid Gel is applied to the burn wound at a dose of 2 g NexoBrid sterile powder mixed with 20g sterile Gel Vehicle per 1% of TBSA (\~ surface of an adult palm) for four hours.
Gel VehiclePLACEBO_COMPARATORGel Vehicle is applied to the burn wound at a dose of 20 g sterile Gel per 1% of TBSA (\~ surface of an adult palm) for four hours.
Standard of Care (SOC)ACTIVE_COMPARATORSubjects in the SOC group may be treated with a combination of surgical and non-surgical eschar removal procedures, according to the investigator's judgment.
Standard of CareACTIVE_COMPARATORNon surgical and Surgical Debridement
Interventions
NameTypeDescription
NexoBridDRUG -
Standard of Care (SOC)PROCEDURE -
Gel VehicleDRUG -
Standard of CarePROCEDURESurgical or Non-Surgical methods for Eschar Removal
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Eligibility Criteria
Age Range18 Years — 77 Years
SexALL
Healthy VolunteersNo
Study Sites29

Inclusion Criteria- Patient level 1. Males and females; ≥ 18 2. Thermal burns caused by fire/flame, scalds or contact, 3. Patient total burns area ≥ 3% DPT and / or FT, 4. Patient total burns area should be ≤ 30% TBSA; SPT, DPT and/or FT in depth, 5. Informed consent can be obtained within 84 hours...

Countries:United StatesBelgiumCzechiaGeorgiaGermanyIsraelItalyRomaniaHungaryIndiaNetherlandsPolandSlovakiaSpainUkraineUnited Kingdom
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