Pharma Focus America

Horizon Therapeutics plc Announces Phase 2 Trial Results for Daxdilimab in Systemic Lupus Erythematosus (SLE) Did Not Achieve Primary Endpoint

Monday, July 24, 2023

Horizon Therapeutics plc (Nasdaq: HZNP) has released a statement regarding the results of its Phase 2 clinical trial evaluating daxdilimab for the treatment of Systemic Lupus Erythematosus (SLE). The trial did not show a statistically significant difference between daxdilimab and placebo on the primary endpoint, which was to measure the proportion of patients achieving a British Isles Lupus Assessment Group (BILAG) 2004 Index-based Combined Lupus Assessment (BICLA) response along with an oral glucocorticoid (OGC) dose of ≤7.5 mg/day (prednisone equivalent) at 48 weeks. BICLA is a composite measure indicating low SLE disease activity.

Although the primary endpoint was not met, there were observed numerical differences in other endpoints. Importantly, no safety concerns were reported during the trial.

Daxdilimab is an anti-ILT7 human monoclonal antibody that targets and depletes certain dendritic cells in order to interrupt the cycle of inflammation that leads to tissue damage in various autoimmune conditions, including SLE.

Despite the trial results, Horizon Therapeutics remains committed to its SLE clinical program and will continue to collaborate with investigators to further assess the data and determine the next steps.

Horizon is also exploring the potential of daxdilimab in other autoimmune conditions such as alopecia areata, discoid lupus erythematosus, and lupus nephritis. Additionally, they have plans to investigate its effectiveness in dermatomyositis or anti-synthetase inflammatory myositis.

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