AnaptysBio has reported that the ARISE-AD trial of its investigational B and T lymphocyte attenuator (BTLA) agonist, ANB032, for treating moderate-to-severe atopic dermatitis (AD), also known as eczema, failed to meet both primary and secondary endpoints.
Despite the setback, the therapy was well tolerated, and no safety concerns were observed.
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The global trial involved 201 subjects from Canada, Australia, Europe, New Zealand, and the US.
It assessed the safety, efficacy, tolerability, pharmacodynamics, and pharmacokinetics of ANB032 as a single agent in subjects with the given condition.
They had a mean baseline Eczema Area and Severity Index score (EASI) score of 27.3 and were either naïve to biologics or were previously treated with therapies such as dupilumab.
Subjects were administered either 100mg or 400mg of the therapy subcutaneously every four weeks, 400mg every two weeks, or a placebo for 12 weeks.
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By GlobalDataAt week 14, the primary and secondary outcomes were evaluated, focusing on improvements in the EASI score and reductions in itch severity.
Despite the tolerability, the therapy failed to meet the primary endpoint of achieving a minimum of 75% improvement in the EASI score or any secondary endpoints.
Notably, the placebo response rates, especially in the US, were higher than historical norms.
Safety and tolerability of ANB032 were confirmed, with the most common adverse events being nasopharyngitis and headache.
AnaptysBio CEO and president Daniel Faga said: “While ANB032 was safe and well tolerated, we’re disappointed by these efficacy results in AD and will discontinue further investment in this asset. Moving forward, our resources and capital will be focused on the rest of our exciting autoimmune portfolio.
“PD-1 is a co-inhibitory receptor found preferentially on activated T cells. We look forward to sharing for rosnilimab, an eplete and agonist targeting PD-1+ T cells, top-line Phase IIb rheumatoid arthritis data in February 2025 and top-line Phase II ulcerative colitis data in Q1 2026, followed by Phase Ib data from our two additional programmes.”
The company is also advancing other immunology therapeutics, including rosnilimab for rheumatoid arthritis and ulcerative colitis, and has several other antibodies in early-stage trials.
In October 2023, the company reported positive topline outcomes from a Phase III trial of imsidolimab for generalised pustular psoriasis.
