Temtokibart

BALLERUP, Denmark I May 09, 2025 I 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 . References SOURCE: LEO Pharma

Danish drugmaker Leo Pharma is yet to discuss the next steps for its eczema prospect temtokibart.\n Leo Pharma has shared phase 2b data on its eczema prospect temtokibart, reporting that the top three doses of the IL-22RA1 blocker beat placebo on the primary endpoint.Temtokibart is designed to block IL-22, a cytokine implicated in eczema, and partially inhibit IL-20 and IL-24 signaling. The mechanism of action sets temtokibart apart from established eczema drugs such as Sanofi and Regeneron’s blockbuster immunology med Dupixent, which blocks IL-4 and IL-13, and JAK inhibitors including AbbVie’s Rinvoq. Leo linked temtokibart and Dupixent to comparable changes in eczema in a phase 2a trial.The phase 2b trial compared four doses of temtokibart to placebo in 262 adults with moderate to severe atopic dermatitis, the most common type of eczema. Friday, Leo said the top three doses of temtokibart beat placebo on the primary endpoint, which tracked change in eczema area and severity over 16 weeks.Leo is yet to share numbers from the trial. The only other details revealed in the top-line release relate to safety and tolerability. Leo said the treatment was generally well tolerated, with no dose dependency. Most adverse events were mild or moderate in severity and not considered related to treatment. The Danish drugmaker is yet to discuss the next steps, only revealing that it is collecting and evaluating the full data set and will provide detailed results at a later date. Leo’s decisions about the candidate have implications for argenx, which discovered the candidate.Argenx disclosed preclinical development of ARGX-112, the asset now called temtokibart, in 2013 and struck a deal with Leo two years later. Leo paid 4.5 million euros ($5 million) upfront. In 2022, Leo paid a further 5 million euros to take up its option on the candidate. Leo now has an exclusive global license, and argenx is eligible for up to 120 million euros in development, regulatory and commercial milestones.