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NexoBrid

Phase 3

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

Success Probability

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Trial Design

RandomizedPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment320

FDA Designations

No designations recorded

Clinical trial landscape

NexoBrid · 2 trials · 1 indication

Phase 3 2
NCT02148705A Study to Evaluate the Efficacy and Safety of NexoBrid in Subjects With Thermal BurnsThermal Burns
COMPLETED175 Analytics
NCT02278718A Study to Evaluate the Efficacy and Safety of NexoBrid in Children With Thermal Burns Compared the Standard of CareThermal Burns
COMPLETED145 Analytics
PHASE3COMPLETED
A Study to Evaluate the Efficacy and Safety of NexoBrid in Subjects With Thermal Burns
Thermal Burns
NCT02148705175
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PHASE3COMPLETED
A Study to Evaluate the Efficacy and Safety of NexoBrid in Children With Thermal Burns Compared the Standard of Care
Thermal Burns
NCT02278718145
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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 to 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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Frequently asked questions about NexoBrid

What is NexoBrid used for?

NexoBrid is used for the treatment of thermal burns. It is an investigational small molecule being developed by MediWound Ltd. for patients with thermal burn injuries, including both adults and children.

What does NexoBrid target?

NexoBrid is a small molecule that targets the eschar tissue in thermal burns, helping to remove dead tissue from the wound site. Its mechanism involves the selective debridement of burn eschar, which is the dead tissue that forms over a burn wound.

Who makes NexoBrid?

NexoBrid is being developed by MediWound Ltd., a biopharmaceutical company. MediWound is publicly traded on the Nasdaq under the ticker symbol MDWD.

What phase is NexoBrid in?

NexoBrid is in Phase 3 clinical development. It has completed two Phase 3 trials for thermal burns, and it remains an investigational drug that has not yet been approved by regulatory authorities.

What clinical trials is NexoBrid in?

NexoBrid has completed two Phase 3 clinical trials. The first, NCT02148705, evaluated its efficacy and safety in 175 adults with thermal burns. The second, NCT02278718, evaluated its efficacy and safety in 145 children with thermal burns compared to standard of care.

Is NexoBrid the same as any other drug?

NexoBrid is the sole name used for this investigational drug in the clinical trial data. No alternative names have been associated with it in the available information.