Oleogel-S10 shows long-term efficacy and safety in dystrophic epidermolysis bullosa

Oleogel-S10 displayed long-term efficacy with regard to wound healing in patients with dystrophic epidermolysis bullosa (DEB). Furthermore, 24-month follow-up data demonstrated that this topical therapy was well tolerated in this population.

“DEB is characterised by varying degrees of skin fragility and impaired wound healing,” outlined Prof. Dedee Murrell (University of New South Wales, Australia) [1,2]. “The majority of patients and caretakers think that ‘accelerated wound healing’ should be a top priority in the development of future treatment options [3]. Since we know that abnormal wound healing is a driver for systemic disease, therapies addressing this issue should be a key priority indeed,” Prof. Murrell stated.

The phase 3 EASE study (NCT03068780) randomised 252 participants from 49 study sites in 26 countries with epidermolysis bullosa 1:1 to standard-of-care plus Oleogel-S10, a drug that is designed to target wound healing, or to standard-of-care alone; participants with DEB comprised most of the study population (n=195). Previous results already showed that the experimental arm outperformed the control arm in terms of the primary endpoint, which was the proportion of patients with complete closure of the target wound within 45 days (41.3% vs 28.9%; 95% CI 1.01–2.05; P=0.013)  [4].  In total, 205 participants entered the open-label part of the EASE trial. Prof. Murrell presented the safety and efficacy results of this sub-population of participants after 24 months of follow-up [1].

Improvements in Body Surface Area Percentage (BSAP) and EB Disease Activity and Scarring Index (EBDASI) were maintained up to month 24 of follow-up in patients with DEB. Adverse events (AEs) of any grade were reported in 77.1% of the participants and 24.4% of the participants experienced serious AEs. Wound complication (41%), anaemia (18%), wound infection (10.2%), pyrexia (9.8%), and oesophageal stenosis (9.3%) were the most common AEs. AEs led to study withdrawal for 7.8% of the participants.

Prof. Murrell concluded that the 24-month data on Oleogel-S10 showed sustained efficacy and an acceptable safety profile of this agent in patients with DEB.

1. Murrell DF, et al. Long-term safety and efficacy of Oleogel-S10 in dystrophic epidermolysis bullosa: Sub-analysis from the 24-month open-label EASE study. Late-breaker Session 5, WCD 2023, 3–8 July, Singapore, Singapore.
2. Bruckner AL, et al. Orphanet Journal of Rare Diseases. 2020;15(1):1.
3. Has C, et al. Br J Dermatol. 2020;183(4):614­­–627.
4. Kern JS, et al. Br J Dermatol. 2023;188(1);12–21.