Date: 6/13/25
Yuhan Corporation presented positive Phase 1b Part 2 results for its investigational anti-IgE biologic Lesigercept (YH35324) at the EAACI 2025 Annual Meeting in Glasgow. Lesigercept is a novel Fc-fusion protein that binds to both circulating free IgE and FcεRIα autoantibodies, offering a dual mechanism to alleviate allergic symptoms. The study focused on 9 patients with chronic spontaneous urticaria (CSU) inadequately controlled by omalizumab and H1-antihistamines. A single 6 mg/kg subcutaneous dose of Lesigercept was evaluated over 8 weeks. Results showed stronger and more sustained suppression of free IgE compared to the control, with higher rates of symptom control based on UAS7 scores. In pooled analysis from Part 1 and 2, significant symptom reduction was observed in both omalizumab-naïve and omalizumab-refractory patients. Consistent responses were also seen across subtypes defined by BHRA (Basophil Histamine Release Assay) status, indicating broader applicability across CSU patient populations, including Type IIb BHRA-positive cases, where omalizumab is less effective. According to Yuhan’s Head of R&D, Dr. Yeol-Hong Kim, Lesigercept demonstrated meaningful clinical improvement in patients unresponsive to both antihistamines and omalizumab. Final analyses on repeat dosing safety and PK/PD profiles are underway, with plans being developed for the next stage of clinical development. Lesigercept was originally in-licensed from GI Innovation in 2020. Yuhan holds global rights excluding Japan, which were out-licensed to Maruho in 2023.
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