Oleogel-S10 Significantly Improves Epidermolysis Bullosa Wounds at 12 Months

A new phase 3 trial assessing a novel topical gel for the treatment of young patients with epidermolysis bullosa (EB) wounds show the birch bark-based product achieved nearly 50% heal of targeted wounds over 12 months.

The interim EASE findings, presented in a late-breaking session at the American Academy of Dermatology (AAD) 2022 Annual Meeting in Boston, show birch triterpenes (Oleogel-S10) may provide a unique and broadly-applicable benefit for patients with rare, often deadly skin condition.

In an interview with HCPLive at AAD 2022, study author Dedee F. Murrell, MD, director of dermatology at St. George Hospital, USNW, discussed the clinical history of Oleogel-S10 leading up to the new phase 3 and open-label extension data. As she noted, the topical therapy was previously developed and studied in Germany, where among its considered uses has been in shortening the skin’s healing time for burns.

Previous phase 2 trial data showed the therapy’s potential for EB, a condition which variously burdens young patients while carrying a significantly great risk of mortality.

“In the severe cases that were featured in the study, it shortens the life expectancy significantly,” Murrell explained. “Many of these children die in infancy, some of them live until early adulthood, and it wasn’t until recently until with management of the internal complications that result from chronic anemia, blood loss from the wounds, chronic infection that people were living beyond their 20s.”

In her team’s phase 3 research, investigators compared Oleogel S-10’s efficacy and safety versus a sunflower-based vehicle gel—stratifying patients by target wound size and including both prominent subtypes of EB manifestation.

Approximately 41% of all target wounds in patients with EB treated with the investigative product were healed within 12 months, versus about 28% in those in the vehicle arm. What’s more, the gel significantly decreased the total body surface area of EB among treated patients compared to the vehicle arm.

Listen to Murrell explain the study’s makeup and outstanding results in the video above.