Temtokibart Demonstrates Efficacy in Adults With Moderate to Severe Atopic Dermatitis

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LEO Pharma recently announced positive topline results from a phase 2b trial evaluating the efficacy and safety of temtokibart for the treatment of moderate to severe atopic dermatitis in adult patients.¹ The company said it is currently collecting and evaluating the full data set from the study and plans to present it at a later date.

Results from the study (NCT05923099) showed that temtokibart achieved positive results on the primary endpoint of percent change in Eczema Area and Severity Index (EASI) score. The therapy was also seen to be generally well-tolerated. The majority of adverse events were non-serious, mild or moderate in severity, and were not considered to be related to the treatment.

“Atopic dermatitis is a complex immunological condition, and patients living with this debilitating disease still face unmet needs,” Jacob Pontoppidan Thyssen, chief scientific officer and executive vice president of Science, Search & Innovation at LEO Pharma, said in a release.¹ “LEO Pharma is committed to making a fundamental difference for these patients, and we are encouraged by the results of this phase 2b trial, which has explored how to target the disease from a different angle with a different mechanism of action, compared to what is commonly used today to treat atopic dermatitis.”

Temtokibart is an investigational monoclonal antibody that blocks the IL-22RA1 receptor subunit. The IL-22RA1 receptor subunit is a protein that forms part of the interleukin-22 (IL-22) receptor complex, which plays a role in immune responses and inflammation.² The IL-22 cytokine is known to be elevated in patients with atopic dermatitis and is inhibited by the therapy.

The study was a randomized, double-blind, placebo-controlled, multi-site, parallel-group, dose-finding phase 2b trial evaluating the efficacy and safety of temtokibart administered subcutaneously in adult patients with moderate to severe atopic dermatitis. The study cohort included 262 adult patients between the ages of 18 and 75 who randomly received 1 of 4 doses of temtokibart or a placebo for 16 weeks with 16 weeks of follow up.

The study showed that, from baseline to week 16, patients who received 3 of the highest temtokibart doses achieved a positive change in EASI scores. The study also showed that there was no dose dependency.

“These results further add to the understanding of the mode of action of temtokibart and its potential abilities to address unmet needs in diseases where the IL-22 pathway is known to play a key role—in medical dermatology and beyond,” Thyssen said in a release.¹

References

1. LEO Pharma announces positive topline phase 2b results for temtokibart in moderate-to-severe atopic dermatitis. Press release. LEO Pharma. May 9, 2025. Accessed May 9, 2025. https://www.businesswire.com/news/home/20250509981022/en/LEO-Pharma-announces-Positive-Topline-Phase-2b-Results-for-Temtokibart-in-Moderate-to-Severe-Atopic-Dermatitis
2. IL22RA1 interleukin 22 receptor subunit alpha 1 [ Homo sapiens (human) ]. Report. NIH. May 3, 2025. Accessed May 9, 2025. https://www.ncbi.nlm.nih.gov/gene/58985

[This article was originally published by our sister publication, Drug Topics.]