A multinational, phase 3 study with Oleogel-S10 for epidermolysis bullosa was the first to reach its primary endpoint. Complete wound closure was reached by 41.3% of wounds treated with Oleogel-S10 versus 28.9% of those treated with a control gel.
A specific treatment for epidermolysis bullosa (EB) has been lacking as the standard of care until now comprised non-adhesive bandages and topical treatments (i.e. anti-microbials, corticosteroids). The agent that is expected to change this is derived from the bark of the birch tree. Oleogel-S10 consists of 10% dry extract from this bark together with 90% of pure sunflower oil, and it that can be applied directly to the open wound during dressing changes.
The phase 3 EASE trial enrolled 252 patients from 58 sites in 28 countries . The target wound had to be a partial-thickness wound aged ≥21 days and <9 months, median wound age was 35.5 days. The double-blind treatment with either Oleogel-S10 or control gel, both with standard of care, lasted 90±7 days and was continued in an open-label extension. The primary endpoint was complete wound closure rate within 45 days.
The age of participants ranged from 21 days to adults, about 70% being under 18 years; 60.1% were male and 51.6% underweight, the latter to be expected in EB patients according to Prof. Dedee F. Murrell (St George Hospital, University of New South Wales, Australia). The majority of study subjects (78.5%) suffered from recessive dystrophic EB.
Complete wound closure was achieved by 41.3% of the target wounds in the Oleogel-S10 group versus 28.9% of wounds in the control gel group (P=0.013). “This is the first time that a phase 3 trial in EB has met its primary endpoint,” Prof. Murrell pointed out. Looking at the subgroups, she explained that the treatment benefit was being driven by the acceleration in the group with recessive dystrophic EB. This subtype had the greatest benefit with the difference between Oleogel-S10 and control gel reaching high statistical significance (P=0.008).
“The wound healing trajectories demonstrate that Oleogel-S10 accelerates wound healing in a subset of wounds; however, as expected, with good wound care the control group begins to catch up later by 90 days,” said Prof. Murrell. She added that the control arm never overtook the Oleogel-S10 arm.
In general, 81.2% of the patients had some sort of adverse event (80.7% Oleogel-S10; 80.7% control gel), mostly mild and moderate. “A low number of target wound infections occurred: only 8 overall, 5 patients had target wound infections reported as adverse events, with 4 of these occurring in the control group,” Prof. Murrell informed.
In conclusion, Prof. Murrell saw Oleogel-S10 as a well-tolerated and potentially important advancement for patients and their families, especially for those affected with recessive dystrophic EB
- Murrell DF, et al. Efficacy and safety of Oleogel-S10 for epidermolysis bullosa – results of 3 months double-blind treatment during the phase 3 study ‘EASE'. D3T03.3B, EADV Virtual, 29-31 October 2020.
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