Oleogel-S10 is a herbal medicinal product which contains birch triterpenes from birch bark. This sterile gel is being developed to speed up healing of skin wounds in adults and children with severe subtypes of epidermolysis bullosa (EB), these subtypes are dystrophic EB and junctional EB. EB is a rare and distressing genetic skin condition where the outer layer of the skin separates from the inner layer and renders the skin more susceptible to wounds such that minor friction results in partial thickness wounds occurring. People with EB need to carefully manage these wounds with a need to clean and bandage them very frequently which is painful and takes considerable time. There is currently no approved treatment for EB.
Oleogel-S10 accelerates wound closure through effects of birch triterpenes on inflammation and epithelialisation during wound healing involving keratinocyte differentiation and migration.
Oleogel-S10 is under investigation in a Phase 3 registration clinical trial, the phase 3 double blind phase of the study is complete and met its primary endpoint on time to first target wound closure (p=0.013). The 24 month open label extension study is ongoing (NCT03068780).
AMYT/ALL/007 August 2021