Yuhan Corporation Launches Full-Scale Global Phase 2 Trial of Allergy Drug Candidate Lesigercept

Global Phase 2 in 150 Patients
Putting Its Differentiation Strategy to the Test

Yuhan Corporation announced on February 19 that it is moving into full-scale multinational Phase 2 clinical trials of lesigercept (development code YH35324), a novel anti-immunoglobulin E (anti-IgE) Fc fusion protein candidate, in patients with chronic spontaneous urticaria (CSU).

Yuhan Corporation has registered the main Phase 2 trial plan for lesigercept on ClinicalTrials.gov, the clinical trial information disclosure site of the U.S. National Institutes of Health (NIH). The Phase 2 trial is designed to evaluate the safety and efficacy of lesigercept versus placebo over 12 weeks in 150 patients with CSU. The primary endpoint is the change from baseline in UAS7 (Urticaria Activity Score over 7 days) at Week 12. The trial will be conducted in Asia and Europe, including the Republic of Korea, Japan, China, Bulgaria, and Poland.

Exterior view of Yuhan Corporation headquarters in Dongjak-gu, Seoul. Yuhan Corporation

This multinational Phase 2 trial is scheduled to move into full operation starting with trial initiation in February this year, with Last Subject Out anticipated in July next year. The company aims to obtain the main topline results in the fourth quarter of next year. Following Phase 2 IND (Investigational New Drug) approval from the Ministry of Food and Drug Safety in October last year, Yuhan Corporation also secured IND approval from Chinese regulatory authorities in February this year, thereby expanding the foundation for operating the multinational Phase 2 trial. In several European countries, clinical trial authorization (CTA) applications are currently under review, and the number of participating countries is expected to expand stepwise in line with approval timelines.

Yuhan Corporation confirmed safety and preliminary proof of concept in its prior Phase 1 study, and reported that, in particular, suppression of free serum IgE in CSU patients tended to be stronger and more sustained compared with the active comparator omalizumab. The company also stated that signals of symptom improvement were observed based on UAS7, the CSU clinical assessment index.

The aspect the company is particularly emphasizing in this Phase 2 trial is its patient enrollment strategy. To clearly identify differentiation, Yuhan Corporation plans to assess efficacy and safety not only in patients without prior exposure to omalizumab, but also in those who had an insufficient response to existing omalizumab treatment. According to the company, “omalizumab non-responders” will be defined based on clinically meaningful criteria and will be selected through a comprehensive review of treatment history, duration and dose of administration, and response assessments (UAS7 and investigator judgment, among others). Through this approach, the company aims to explore at an early stage the treatment potential in patient groups with substantial unmet needs in real-world clinical practice.

Yeolhong Kim, President and Head of R&D at Yuhan Corporation, said, “This Phase 2 trial in patients with chronic spontaneous urticaria will be conducted with the aim of confirming the safety, efficacy, and clinical strengths of lesigercept in a broader patient population across Asian and European countries,” adding, “It will become another best-practice example of our strategy to expand global R&D through open innovation.”

Yuhan Corporation plans to secure meaningful data from this Phase 2 trial and, based on the results, to begin concretely shaping its follow-up global development strategy and expanding into additional indications.

This content was produced with the assistance of AI translation services.