Yuhan Corporation Announces Phase 1b Results for Allergy Treatment "Lesigercept"

Yuhan Corporation announced on the 16th that it presented the results of a Phase 1b clinical trial for its allergy treatment “Lesigercept” (development code YH35324) at the annual scientific meeting of the European Academy of Allergy and Clinical Immunology (EAACI) 2026, held in Istanbul, Türkiye.

Lesigercept is a novel candidate drug in the anti-immunoglobulin E (anti-IgE) class, designed as a long-acting, high-affinity IgETrap-Fc fusion protein. It is engineered to neutralize free IgE in the bloodstream, thereby regulating IgE-mediated allergic inflammatory responses.

Central Research Laboratory of Yuhan Corporation, Giheung-gu, Yongin City, Gyeonggi Province, Yuhan Corporation

This Phase 1b clinical trial enrolled a total of 46 participants to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic characteristics of repeated administration of Lesigercept. Cohorts 1 to 4 included healthy subjects with an atopic background and patients with allergic diseases, while Cohort 5 comprised patients with moderate to severe atopic dermatitis.

The trial results showed that Lesigercept maintained a favorable safety profile even with repeated dosing, and there were no cases of premature discontinuation or serious adverse events related to the drug. In addition, drug exposure increased as the dose was escalated, and the concentration of free IgE in the blood decreased in a dose-dependent manner, with the reduction tending to persist for a longer duration.

Notably, in Cohort 3, which included subjects with high baseline total IgE levels, the median duration for which blood free IgE remained below 25 ng/mL was 15 days in the Lesigercept group, compared to 0 days in both the placebo and omalizumab groups. This result suggests that Lesigercept has the potential to deliver strong and sustained effects even in patients with high blood IgE concentrations, indicating its potential to address unmet clinical needs.

Furthermore, these results were consistent with the safety and pharmacodynamic characteristics confirmed in the previously announced Phase 1a and exploratory proof-of-concept Phase 1b studies in patients with chronic spontaneous urticaria.

Yulhong Kim, Head of R&D at Yuhan Corporation, stated, “Through this clinical study, Lesigercept demonstrated a favorable safety profile under repeated dosing conditions and showed the potential for faster and more sustained suppression of free blood IgE compared to existing treatments. We plan to continue evaluating its therapeutic potential for various allergic diseases through ongoing global Phase 2 clinical trials and further clinical development.”

Lesigercept is a novel drug candidate introduced by Yuhan Corporation from GI Innovation in July 2020, with both companies conducting joint research and development. Yuhan Corporation holds the global rights to the drug, except for Japan.

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