From EADV: Temtokibart Shows Sustained Efficacy in AD; New DELTA TEEN Data
Temtokibart phase 2b trial met primary and secondary endpoints in moderate-to-severe AD, with sustained response and acceptable safety.
Delgocitinib cream achieved positive outcomes in the DELTA TEEN phase 3 trial for adolescents with chronic hand eczema (CHE).
Pooled safety data from five delgocitinib trials confirmed consistent safety in adults up to 52 weeks.
LEO Pharma announced data from several important trials and presented updates on delgocitinib
LEO Pharma presented phase 2b data for its investigational agent temtokibart (LEO 138559) at the 2025 European Academy of Dermatology and Venereology (EADV) Annual Meeting in Paris. According to LEO, the drug is a novel monoclonal antibody designed to inhibit the IL-22RA1 receptor subunit, resulting in the blockage of IL-22, IL-20, and IL-24 signaling. The drug remains investigational and is not yet approved by any regulatory authority.
Temtokibart Effective in AD
The randomized, double-blind, placebo-controlled, dose-finding trial enrolled 262 adult patients with moderate-to-severe AD treated with four doses of subcutaneously administered temtokibart. The study authors reported that it had met its primary endpoint of percent change from baseline in Eczema Area and Severity Index (EASI) at week 16.
Researchers reporte EASI reductions in the 600 mg (−61.2%), 450 mg (−57.1%), and 300 mg (−64.3%) groups vs placebo (−41.7%). EASI improvements were detectable at week 1 for the 450 mg and 300 mg groups, and by week 2 for the 600 mg group, and gains were sustained through week 32 in the 600 mg and 300 mg arms, despite treatment cessation after week 14.
Temtokibart was well tolerated. There was a low incidence of conjunctivitis and no apparent signal for herpes.
“These results are promising, as they provide further evidence of the value of targeting the IL-22 pathway in AD, via IL-22RA1 , offering a potential novel approach to the currently existing therapies used to treat atopic dermatitis” said Professor Stephan Weidinger, Professor and Chair for Dermatology at the Christian-Albrechts-University, Director of the Department of Dermatology and Allergy at the University Hospital Schleswig-Holstein, Germany, and the International Coordinating Investigator for the Phase 2b trial, in a news release. “Patients with moderate-to-severe atopic dermatitis still face numerous unmet needs, so we welcome any new options that could improve their disease while limiting burdensome side effects”
Biomarker Data
In a separate presentation, biomarker data demonstrated broad dampening of Th2 and Th17/22 immune markers and restoration of epidermal barrier-related gene expression at 16 weeks. Clinical improvements in EASI, SCORAD, DLQI, and POEM were all associated with reductions in T-cell and cytokine pathways implicated in AD (all associations reached statistical significance).
“AD is a complex and heterogenous disease, and there remains a significant need for further understanding the effect of targeting different pathways," said Professor Emma Guttman-Yassky, Waldman Professor of Dermatology and Immunology and the Health System Chair of the Department of Dermatology at the Icahn School of Medicine at Mount Sinai, USA, Investigator and senior author of the Phase 2b biomarker abstract, in a press release. "By investigating biomarkers in the clinical programs we are increasing our understanding of the disease, moving us closer to a more tailored approach of treating AD via different mechanisms of action. These results provide further evidence that the IL-22 pathway is a key driver of disease activity in AD and that there is a strong correlation between clinical effects and dampening of several immune pathways of importance in AD, when targeting the IL-22RA1 subunit.”
DELTA TEEN: Delgocitinib For Teens with Chronic Hand Eczema
LEO Pharma also presented new late-breaking data for delgocitinib cream in chronic hand eczema (CHE). In the phase 3 DELTA TEEN trial, delgocitinib cream demonstrated superior efficacy compared with cream vehicle in adolescents aged 12 to 17 years with moderate-to-severe CHE who had an inadequate response or contraindications to topical corticosteroids. After 16 weeks, 63.5% of patients in the delgocitinib group achieved treatment success on the Investigator’s Global Assessment for CHE (IGA-CHE) compared with 29.2% in the vehicle arm. The topical JAK inhibitor also outperformed vehicle across secondary endpoints, including Hand Eczema Severity Index 90 (HECSI-90) and reductions in itch, pain, and overall symptom scores.
No serious adverse events were reported. Adverse events were primarily mild or moderate, and rates of drug-related events or discontinuations were numerically lower with delgocitinib cream than with vehicle.
“The findings from the phase 3 DELTA TEEN trial may offer hope for young people whose CHE can impact their wellbeing and leisure activities,” said Professor Sonja Molin, Academic Dermatologist at Charité Universitätsmedizin Berlin and coordinating investigator, in a news release.
A second presentation reported pooled data from five phase 2b and phase 3 trials of delgocitinib cream in adults with CHE. The integrated analysis showed a consistent safety profile for up to 52 weeks of treatment, with adverse event rates comparable to vehicle and lower than oral alitretinoin. Rates decreased over time in long-term.
“The results from the pooled safety analysis are incredibly valuable as they further strengthen our understanding of this treatment option,” said Dr. Robert Bissonnette, lead study author from Innovaderm Research, Montreal, in a news release. “It is reassuring to see that the safety data pooled from five clinical trials remains consistent with previously established findings.”
Source: LEO Press release, September 17, 2025
LEO Press release, September 18, 2025