temtokibart (LEO 138559) / argenx, LEO Pharma - LARVOL DELTA

LEO Pharma announces Positive Topline Phase 2b Results for Temtokibart in Moderate-to-Severe Atopic Dermatitis (Businesswire) - P2b | N=262 | NCT05923099 | Sponsor: LEO Pharma | "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...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....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."

P2b data • Atopic Dermatitis

A Trial to Evaluate the Efficacy and Safety of Different Doses of LEO 138559 in Adults With Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=262 | Completed | Sponsor: LEO Pharma | Active, not recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

An Evaluation of LEO 138559 in Adults With Moderate to Severe Atopic Dermatitis. (clinicaltrials.gov) - P2 | N=58 | Completed | Sponsor: LEO Pharma | Phase classification: P2a ➔ P2

Phase classification • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

LEO Pharma Presents Late-Breaking Results from the Phase 2a Mechanism of Action Trial of Temtokibart and Dupilumab in Moderate-to-Severe Atopic Dermatitis at the 2024 EADV Annual Meeting (Businesswire) - P2a | N=13 | NCT05470114 | Sponsor: LEO Pharma | "LEO Pharma...announced positive results from the Phase 2a Mechanism of Action (MoA) trial, which assessed the mechanistic impact of investigational temtokibart and dupilumab in patients with moderate-to-severe atopic dermatitis (AD). Results were shared as a Late Breaker oral presentation at the 2024 EADV Annual Meeting...The results showed that temtokibart 450 mg once every 2 weeks dosing (Q2W, n=8) significantly improved skin hydration faster and to a greater extent than dupilumab 300 mg Q2W (n=4)...Subsequent improvement in barrier function markers including terminal differentiation markers and cell adhesion molecules were also shown with temtokibart treatment. In line with its respective MoA, dupilumab showed a strong and consistent decrease in Type 2-associated inflammatory markers particularly in immune cells and fibroblasts....The Phase 2b trial has finalized recruitment, and results are expected in Q1 2025."

Enrollment status • Late-breaking abstract • P2a data • P2b data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Individual responses to IL-22RA1 inhibition in Asian patients with moderate-to-severe atopic dermatitis in Phase 1 and 2a clinical trials (EADV 2024) - P1, P2, P2a | "Temtokibart (LEO 138559) is a monoclonal antibody that specifically targets the IL-22 receptor subunit alpha-1 (IL-22RA1)... Although the sample size is small, these data are the first to indicate that targeting the IL-22 pathway with an anti-IL-22RA1 antibody in Asian AD patients can provide early and substantial/profound clinical responses. Notably, strong responses at Week 16 in two phase 1 trial patients, despite no treatment for 3 months, suggests a potential for less frequent dosing with temtokibart."

Clinical • P1 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Psoriasis • IL22

LEO Pharma Unveils Most Extensive EADV Program To Date with 5 Late Breaking Abstracts and 23 Posters Sharing Clinical and Real-World Data (Businesswire) - "LEO Pharma A/S, a global leader in medical dermatology, will present new clinical and real-world data from across its portfolio of products at the upcoming 33rd European Academy of Dermatology and Venereology (EADV) Congress. The event will be held from the 25th to the 28th of September in Amsterdam, Netherlands, where LEO Pharma will present 5 coveted late-breaking presentations in addition to 23 scientific posters for a range of skin conditions, forming the largest collection of data LEO Pharma has ever shared at the EADV congress."

Clinical data • Atopic Dermatitis • Dermatology • Immunology • Psoriasis

A Trial to Evaluate the Efficacy and Safety of Different Doses of LEO 138559 in Adults With Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=262 | Active, not recruiting | Sponsor: LEO Pharma | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Individual patient responses to IL-22RA1 inhibition in a Phase 2a monotherapy trial for moderate-to-severe atopic dermatitis (AAD 2024) - P2a | "In a phase 2a study (NCT04922021), temtokibart (LEO 138559), a monoclonal antibody that specifically targets the IL-22 receptor subunit alpha-1 (IL-22RA1), was well-tolerated and significantly improved the signs and symptoms of AD compared to placebo over 16 weeks...At Week 16, higher percentages of patients receiving temtokibart achieved target EASI improvements from baseline relative to placebo, including EASI-75 (51.7% vs. 24.1%), EASI-90 (34.5% vs. 10.3%), and EASI-100 (20.7% vs. 0%). These data build on the primary analysis and demonstrate that targeting IL-22RA1 with temtokibart benefits a large proportion of patients with deep responses, as early as Week 4 and with increased response rates at Week 16, including 20% of patients achieving the high bar of EASI-100."

Clinical • Monotherapy • P2a data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • IL22

LEO Pharma to Maintain Leadership Role at AAD in 2024 with New Late-Breaking Data Spanning Multiple Therapeutic Areas (Businesswire) - "LEO Pharma A/S...will present a breadth of new data on moderate-to-severe chronic hand eczema (CHE), congenital ichthyosis (CI) and atopic dermatitis (AD) at the upcoming 82nd American Academy of Dermatology (AAD) Annual Meeting. The event is being held from March 8th to 12th in San Diego, California....Adbry (tralokinumab-ldrm) data will be shared during the annual meeting as an e-poster summarizing results from the ECZTEND trial investigating the stability of long-term therapeutic responses to tralokinumab in adults with moderate-to-severe AD."

Late-breaking abstract • P2a data • P3 data • Atopic Dermatitis • Dermatitis • Immunology

A Multi-omics Disease Signature Trial in Adult Patients With Moderate to Severe AD (clinicaltrials.gov) - P2 | N=13 | Completed | Sponsor: LEO Pharma | Active, not recruiting ➔ Completed | Trial completion date: Jan 2024 ➔ Oct 2023

Trial completion • Trial completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Trial to Evaluate the Efficacy and Safety of Different Doses of LEO 138559 in Adults With Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=250 | Recruiting | Sponsor: LEO Pharma | Phase classification: P2b ➔ P2

Phase classification • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Clinical response to IL-22RA1 blockade is associated with reduction of systemic inflammation (ISDS 2023) - P2a | "Temtokibart (LEO 138559) is a monoclonal antibody specifically targeting IL-22 receptor subunit alpha-1 (IL-22RA1), which is predominantly expressed by epithelial cells... Blockade of IL-22RA1 resulted in significant reduction of a broad range of tissue secreted chemokines, known to drive immune cell recruitment and activation. This supports that the clinical response observed after 16 weeks of temtokibart treatment was associated with decreased systemic inflammation."

Clinical • Atopic Dermatitis • Dermatitis • Dermatology • Inflammation • CCL20 • CCL3 • CXCL8 • IL22

A Trial to Evaluate the Efficacy and Safety of Different Doses of LEO 138559 in Adults With Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov) - P2b | N=250 | Recruiting | Sponsor: LEO Pharma | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Efficacy and safety of IL-22RA1 inhibition in patients with moderate-to-severe atopic dermatitis: results from a Phase 2a monotherapy trial (EADV 2023) - P2a | "In this Phase 2a study, targeting IL-22RA1 with LEO 138559 for 16 weeks improved the signs and symptoms of AD compared to placebo and was well-tolerated. These data are the first to demonstrate the efficacy and safety of an IL-22RA1 targeting antibody for the treatment of moderate-to-severe AD. In vitro data showing LEO 138559 blocked IL-20 receptor type 2-dependent IL-20 and IL-24 signaling, in addition to IL-22 signaling, suggest that the mechanism of action of LEO 138559 in AD goes beyond inhibition of IL-22-mediated skin inflammation."

Clinical • Monotherapy • P2a data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • IL22

Temtokibart achieves First Subject First Treatment (FSFT) milestone in Phase 2b trial (Businesswire) - "LEO Pharma A/S...announced the First Subject First Treatment (FSFT) milestone for the Phase 2b clinical trial for temtokibart, LEO Pharma's IL-22RA1 antibody. The first patient dose was successfully administered on the 4th of October at the DermEdge Research Center in Ontario, Canada....The Phase 2b trial will be overseen by a specialist steering committee, the purpose of which is to provide critical scientific guidance, oversee trial conduct and drive trial results, analysis and scientific communications."

Trial status • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Trial to Evaluate the Efficacy and Safety of Different Doses of LEO 138559 in Adults With Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov) - P2b | N=250 | Not yet recruiting | Sponsor: LEO Pharma

New P2b trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Blockade of the IL-22 Receptor: Novel Treatment Approach in AD (Physician’s Weekly) - "'The agent really works fast, Dr. Thaci said, adding that 'the antibody was superior regarding all secondary endpoints, namely EASI-75, EASI-90, and EASI-100 response and in the investigator's global assessment.'"

Media quote

LEO Pharma Presents Late-Breaking Positive Phase 2a Efficacy and Safety Results of LEO 138559 in Moderate-to-Severe Atopic Dermatitis at the 2023 AAD Annual Meeting (Yahoo Finance) - "Results presented at AAD 2023 demonstrated that investigational agent LEO 138559 met its primary endpoint of change in the Eczema Area and Severity Index (EASI) compared with placebo...'These results are promising, as they demonstrate for the first time the potential benefits of targeting the IL-22 receptor which is a new mode of action', said Professor Diamant Thaci..."

Media quote

A Multi-omics Disease Signature Trial in Adult Patients With Moderate to Severe AD (clinicaltrials.gov) - P2 | N=13 | Active, not recruiting | Sponsor: LEO Pharma | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

An Evaluation of LEO 138559 in Adults With Moderate to Severe Atopic Dermatitis. (clinicaltrials.gov) - P2a | N=58 | Completed | Sponsor: LEO Pharma | Active, not recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Multi-omics Disease Signature Trial in Adult Patients With Moderate to Severe AD (clinicaltrials.gov) - P2 | N=12 | Recruiting | Sponsor: LEO Pharma

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Trial to Evaluate Pharmacokinetics, Immunogenicity, Safety, and Tolerability of LEO 138559 in Healthy Japanese Subjects (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: LEO Pharma | Active, not recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Trial to Evaluate Pharmacokinetics, Immunogenicity, Safety, and Tolerability of LEO 138559 in Healthy Japanese Subjects (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: LEO Pharma | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

An Evaluation of LEO 138559 in Adults With Moderate to Severe Atopic Dermatitis. (clinicaltrials.gov) - P2a | N=58 | Active, not recruiting | Sponsor: LEO Pharma | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Trial to Evaluate Pharmacokinetics, Immunogenicity, Safety, and Tolerability of LEO 138559 in Healthy Japanese Subjects (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: LEO Pharma; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology