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DGD

Phase 3

Burn | Small molecule | Other |MediWound Ltd.|Last Updated: Sep 9, 2021

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
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment218
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00324311Enzymatic Debridement in Burns Patients: A Comparison to Standard of CarePHASE3 COMPLETED 182 — — Dec 1, 2005Feb 1, 2010May 10, 201117 Australia, Brazil +8
NCT00898521Feasibility Study: Enzymatic Debridement in Patients With Partial Thickness BurnsPHASE2 COMPLETED 36 — — Dec 20, 2009Dec 2, 2015Sep 9, 20212 India, Israel
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Study Endpoints
Primary Endpoints
Co-primary: % treated wound excised (by tangential/minor/Versajet excision) or dermabrasion, in first surgery, of deep partial wounds
Surgical excision/dermabrasion performed as initial debridement (surgical SOC group) or as first post-debridement procedure (DGD or non-surgical SOC groups)
Co-primary: % treated wound autografted of deep partial wounds
Post-debridement autografts
The primary endpoint is safety as measured by: 1. Systemic an local adverse events, 2. Changes in vital signs and laboratory tests, 3. Time to wound closure.
Throughout the study
Secondary Endpoints
% treated wound excised (by tangential/minor/Versajet excision) or dermabrasion, in first surgery, for all wounds
As for primary endpoint
Time to complete wound closure
% epithelialization assessed post-debridement at weekly intervals until all a patient's wounds closed
Timely eschar removal
Debridement procedures
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
DGDEXPERIMENTAL -
SOCACTIVE_COMPARATOR -
Interventions
NameTypeDescription
DGDDRUGLyophilized, sterile mixture of proteolyzed enzymes; mixed with gel,for topical application.
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Eligibility Criteria
Age Range4 Years — 55 Years
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: 1. Males and females between 4 years to 55 years of age, 2. Thermal burns caused by fire/flame, scalds or contact, 3. Deep partial thickness (mixed deep dermal) and/or full thickness (3°) burn wounds ≥ 5% and ≤ 30% Total Body Surface Area (TBSA); all these wounds must receive st...

Countries:AustraliaBrazilFranceGermanyIsraelItalyPolandRomaniaSlovakiaUnited KingdomIndia
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