Resigercept (development code YH35324), an allergic disease treatment under development by Yuhan Corporation (000100.KS), has confirmed safety and sustained efficacy in a repeat-dose trial.
Yuhan said Monday it presented the Phase 1b results of Resigercept at the European Academy of Allergy and Clinical Immunology (EAACI) 2026 Annual Congress, held in Istanbul, Turkey.
Resigercept is a long-acting, high-affinity anti-immunoglobulin E (IgE) IgETrap-Fc fusion protein new drug candidate. It is designed to neutralize free IgE in the blood and modulate IgE-mediated allergic inflammatory responses.
The Phase 1b trial was conducted in a total of 46 subjects to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of repeat dosing. Cohorts 1 through 4 included healthy individuals with atopic predisposition and patients with allergic diseases, while Cohort 5 included patients with moderate or severe atopic dermatitis.
In the trial, Resigercept showed a favorable safety profile even under repeat-dose conditions. No drug-related serious adverse events (SAE) were reported, and there were no cases of dropout due to adverse events.
Positive results were also confirmed on the efficacy side. Drug exposure increased as the administered dose rose, and free IgE levels in the blood decreased in a dose-dependent manner. The reduction effect also tended to last longer.
In particular, in Cohort 3, which included patients with high baseline total IgE levels, the median duration during which blood free IgE concentration was maintained below 25 ng/mL was 15 days in the Resigercept group. By contrast, the placebo group and the group given omalizumab, an existing treatment, each recorded zero days. The company explained that the result confirms the possibility that Resigercept can show strong and sustained IgE suppression even in high-IgE patients.
These results were consistent with the safety and pharmacodynamic characteristics confirmed in the previously announced Phase 1a study and the proof-of-concept (PoC) Phase 1b study conducted in patients with chronic spontaneous urticaria.
"Through these trial results, Resigercept showed a favorable safety profile even under repeat-dose conditions, and we confirmed the possibility of faster and more sustained suppression of blood free IgE compared with existing treatments," said Kim Yeol-hong, president and head of R&D at Yuhan. "Through ongoing follow-up clinical development, including the global Phase 2 trial currently underway, we plan to continue evaluating its therapeutic potential in various allergic diseases."
Meanwhile, Resigercept is a new drug candidate that Yuhan licensed from GI Innovation in July 2020, with the two companies conducting joint research and development. Yuhan holds the global rights excluding Japan.
