Phase III ECZTRA 6 and ECZTEND trials of Adbry in atopic dermatitis reported at AAD 2023 Annual Meeting.- LEO Pharma

S. aureus is consistently found in the skin lesions of patients with AD and contributes to skin irritation and infections. A correlation between disease severity and S. aureus colonization has been demonstrated in clinical studies. At Week 16, 49% of patients receiving Adbry 150 mg (n=81) and 43% of patients receiving Adbry 300 mg (n=82) went from testing positive for S. aureus to negative in lesional skin, compared to the 14% receiving placebo (n=80). Similar reductions were seen in Adbry-treated patients with S. aureus positive non-lesional skin.

Additional data in adolescent patients from ECZTRA 6 demonstrated that 16 weeks of treatment with Adbry showed an improvement in skin gene expression from a lesional to a non-lesional skin profile. The improvement occurred in 29% (n=29) and 41% (n=27) of the differentially expressed genes in lesional skin in patients treated with Adbry (for the 150 mg and 300 mg groups, respectively), compared to a 4% improvement in the placebo group (n=27). At Week 8, Adbry 150 mg and 300 mg led to 35% 9 (n=29) and 33% (n=27) improvement respectively in gene expression, compared to a 10% (n=27) improvement with placebo.

All participants who completed the ECZTRA 6 trial were eligible to enter the ongoing ECZTEND open-label extension trial. An interim analysis of this trial evaluated the long-term safety and efficacy of Adbry among adolescents from ECZTRA 6 who moved into ECZTEND. The results of the analysis showed that the long-term safety profile of Adbry for up to three years in the adolescent population (n=127) was consistent with that of the ECZTEND adult population, with no new safety issues identified. Additionally, approximately eight out of 10 patients had at least a 75% improvement in the extent and severity of AD (EASI-75) at two years of treatment with Adtralza (84.4% AO (n=109), 78.7% mNRI (n=127), 78.7% LOCF (n=127). The data was presented at the American Academy of Dermatology (AAD) 2023 Annual Meeting. The use of Adbry in adolescent patients aged 12-17 is currently under clinical investigation and the safety and efficacy have not been fully evaluated by the U.S. FDA.