Yuhan Corporation "Resigercept Confirms Symptom Improvement in Phase 1b Clinical Trial"

Yuhan Corporation Headquarters. Photo by Yuhan Corporation

Yuhan Corporation presented the results of the Phase 1b Part 1 clinical trial of lesigercept at the 2025 Annual Meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) held on the 2nd (local time) as a poster presentation.

Lesigercept is a novel Fc fusion protein drug in the anti-immunoglobulin E (anti-IgE) class. Its main mechanism of action is to reduce the level of free IgE in the blood, thereby improving allergic symptoms. AAAAI is a prestigious academic conference attended annually by thousands of allergy experts worldwide, and this year it was held in San Diego, USA.

This clinical trial was a Phase 1b study conducted for preliminary proof of concept at nine university hospitals in South Korea specializing in allergy medicine. Among the three parts (Part 1 to Part 3), the results of Part 1 were presented at this conference. The purpose of Part 1 was to evaluate the characteristics of the investigational drug compared to a control drug over 8 weeks after a single subcutaneous injection of lesigercept at 3 mg/kg or 6 mg/kg, or omalizumab 300 mg, as an add-on therapy to H1 antihistamines in patients with chronic spontaneous urticaria inadequately controlled by H1 antihistamines.

The clinical trial results showed that lesigercept demonstrated safety in patients with chronic spontaneous urticaria and exhibited stronger and more sustained free IgE suppression activity in the blood compared to omalizumab. This is consistent with the Phase 1a clinical data previously presented at international conferences (European Academy of Allergy and Clinical Immunology (EAACI) 2023, AAAAI 2024). Additionally, using the UAS7 (7-day Urticaria Activity Score), a chronic urticaria assessment index, symptom scores were evaluated, and the proportion of patients achieving complete symptom control (UAS7 score of 0) was higher in the lesigercept 6 mg/kg group compared to the omalizumab group.

Kim Yeolhong, Head of R&D at Yuhan Corporation, stated, "In this trial, lesigercept showed actual clinical symptom improvement in patients with H1 antihistamine-resistant chronic spontaneous urticaria, the main target indication for development." He added, "We are currently analyzing the final results of the Phase 1b trial evaluating safety, pharmacokinetics, and pharmacodynamics upon repeated administration, and reviewing the optimal strategy to proceed to the next development stage."

Lesigercept is a new drug licensed by Yuhan Corporation from GI Innovation in July 2020, and joint research and development are currently underway. Yuhan Corporation holds the global rights except for Japan. The Japanese rights, previously held by GI Innovation, were transferred in October 2023 to Maruho, a leading Japanese company in the dermatology field.

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