LEO Pharma announces Positive Topline Phase 2b Results for Temtokibart in Moderate-to-Severe Atopic Dermatitis

GLOBAL RELEASE - NOT INTENDED FOR UK MEDIA

BALLERUP, Denmark, May 9, 2025 – LEO Pharma A/S, a global leader in medical dermatology, today announced positive topline results of the phase 2b trial with temtokibart, an investigational IL-22RA1 antagonist, for the potential treatment of adults with moderate-to-severe atopic dermatitis (AD).

The study was a phase 2b, randomized, double-blind, placebo-controlled, multi-site, parallel-group, dose-finding trial to evaluate the efficacy and safety of different doses of subcutaneously administered temtokibart, also called LEO 138559, in adult subjects with moderate-to-severe AD. ¹

The phase 2b trial achieved positive results for the primary endpoint based on percentage change in EASI (Eczema Area and Severity Index) from baseline to Week 16 for 3 highest doses in adults with moderate-to-severe AD. The treatment was generally well-tolerated, with no dose dependency, and the majority of adverse events observed were non-serious, mild or moderate in severity, and not considered treatment related.

“Atopic dermatitis is a complex immunological condition, and patients living with this debilitating disease still face unmet needs. 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 AD,” said Dr Jacob Pontoppidan Thyssen, Chief Scientific Officer & Executive Vice President, Science, Search & Innovation at LEO Pharma. “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.”

Temtokibart is an investigational monoclonal antibody for the treatment of moderate-to-severe AD, which blocks the IL-22RA1 receptor subunit thereby inhibiting the effect of the interleukin-22 (IL-22) cytokine – known to be elevated in patients with atopic dermatitis.^2-4 

LEO Pharma and argenx, a global immunology company, formed a strategic alliance in 2015 to develop innovative antibody-based solutions for the treatment of chronic inflammation that underlies many skin conditions. LEO Pharma and argenx jointly developed temtokibart under this research agreement and LEO Pharma has subsequently obtained the exclusive license to develop and commercialize temtokibart.

LEO Pharma is currently collecting and evaluating the full data set. Detailed results from the phase 2b trial are planned to be submitted for scientific presentation and publication at a later date.

For more information on the trial (NCT05923099) go to clinicaltrials.gov.

About the Phase 2b trial

The temtokibart phase 2b trial (NCT05923099) is a randomized, double-blind, placebo-controlled, multi-site, parallel-group, dose finding trial to evaluate the efficacy and safety of different doses of subcutaneously administered temtokibart in adult patients with moderate-to-severe atopic dermatitits.¹ Patients were randomized to receive one of four doses of temtokibart or placebo.¹ The primary endpoint is percent change in EASI from baseline to Week 16.¹ The key secondary endpoint is number of treatment-emergent adverse events from baseline to Week 16 per subject.¹

About atopic dermatitis

Atopic dermatitis is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.⁵ Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.⁶ Type 2 cytokines, including IL-13, play an important role in the key aspects of atopic dermatitis pathophysiology.^7,8 Excessive IL-22 production is also known to contribute to the pathogenesis of AD.^9,10

About investigational temtokibart

Temtokibart is an investigational monoclonal antibody that targets the IL-22RA1 receptor subunit, currently in phase 2 development for the potential treatment of moderate-to-severe atopic dermatitis.^{3 4} It blocks the IL-22RA1 subunit and thereby inhibits the effects of the IL-22 cytokine, and also the effects of IL-20 and IL-24 signaling.^3,4 Temtokibart does not bind to the IL-22 cytokine itself.^3,4 LEO Pharma has obtained a worldwide exclusive license to develop and commercialize temtokibart from argenx.

About LEO Pharma

LEO Pharma is a global leader in medical dermatology. We deliver innovative solutions for skin health, building on a century of experience with breakthrough medicines in healthcare. We are committed to making a fundamental difference in people’s lives, and our broad portfolio of treatments serves close to 100 million patients in over 70 countries annually. Headquartered in Denmark, LEO Pharma has a team of 4,000 people worldwide. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. For more information, visit www.leo-pharma.com.

 

Contacts

Jes Frederiksen Global Corporate Communication  +45 53 60 59 48 jebfe@leo-pharma.com

Jeppe Ilkjær Global Corporate Communications  +45 30 50 20 14  JEILK@leo-pharma.com

References

1. NCT05923099. Available at: clinicaltrials.gov/study/NCT05923099. Accessed September 2024.
2. Bangert C, et al. Presented at European Academy of Dermatology & Venereology (EADV) 2024 Annual Meeting, Amsterdam, 25–28 September 2024.
3. Thaçi D, et al. Presented at American Academy of Dermatology (AAD) 2023 Annual Meeting, New Orleans, 17–21 March 2023.
4. Thaçi D, et al. Presented at European Academy of Dermatology and Venereology (EADV) 2023 Annual Meeting, Berlin, 11–13 October 2023.
5. Weidinger S, et al. Lancet 2016;387:1109–1122.
6. Boguniewicz M, et al. Immunol Rev 2011;242:233–246.
7. Tubau C, Puig L. Immunotherapy 2021;13:327–344.
8. Bieber T. Allergy 2020;75:54–62.
9. Gittler JK, et al. J Allergy Clin Immunol 2012;130:1344–1354.
10. Nograles K, et al. J Allergy Clin Immunol 2009;123:1244–1252.

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