에볼루션 바카라사이트 launches global phase 2 trial of lesigercept licensed from GI Innovation

[by Ji, Yong Jun] Yuhan Corporation (hereinafter referred to as Yuhan) announced on February 19 that it will initiate a multinational Phase 2 clinical trial for ‘lesigercept’ (development code: YH35324), a novel anti-IgE Fc fusion protein drug candidate, in patients with chronic spontaneous urticaria (CSU).

Lesigercept is a novel drug candidate that 에볼루션 바카라사이트 licensed from the Korean biopharmaceutical company GI Innovation in July 2020. Under the terms of the agreement, 에볼루션 바카라사이트 holds global rights to the asset, excluding Japan.

에볼루션 바카라사이트 Corporation has registered the key design elements of the Phase 2 clinical trial for lesigercept on ClinicalTrials.gov, the clinical trial information platform operated by the U.S. National Institutes of Health (NIH). The Phase 2 trial is structured to assess the safety and efficacy of lesigercept in 150 patients with CSU following 12 weeks of administration of either the investigational drug or placebo.

The primary endpoint of the study is the change from baseline in the UAS7 (Urticaria Activity Score over 7 Days) at Week 12. The 에볼루션 바카라사이트 is planned to be conducted across multiple sites in Asia and Europe, including South Korea, Japan, China, Bulgaria, and Poland.

This multinational Phase 2 clinical 에볼루션 바카라사이트 is scheduled to start in February of this year, marking the formal initiation of the study. The final patient visit (last subject out) is anticipated in July 2027, with top-line results expected to be disclosed in the fourth quarter of 2027.

에볼루션 바카라사이트 received Phase 2 Investigational New Drug (IND) approval from the Ministry of Food and Drug Safety (MFDS) in October 2025 and subsequently obtained IND approval from Chinese regulatory authorities in February of this year, thereby strengthening the regulatory foundation for its multinational Phase 2 trial. In several European countries, Clinical Trial Applications (CTA) are currently under review, and the number of participating countries is expected to increase gradually in accordance with the respective approval timelines.

에볼루션 바카라사이트 Corporation previously confirmed the safety profile and preliminary proof of concept (PoC) through a Phase 1 clinical study. Specifically, in patients with CSU, the company reported that suppression of free IgE appeared to be stronger and more sustained compared with the reference drug, omalizumab. In addition, the company confirmed signals of clinical improvement in the UAS7-based CSU clinical evaluation indicator.

Yuhan is placing particular emphasis on patient selection (recruitment) in the Phase 2 trial of lesigercept. To more clearly demonstrate clinical differentiation, the study is designed to assess efficacy and safety not only in omalizumab-naïve patients but also in those who have exhibited an inadequate response to prior omalizumab treatment.

In the study, omalizumab non-responders will be identified according to clinically meaningful criteria, incorporating treatment history, duration, and dosing exposure, as well as objective response assessments (UAS7 scores and investigator evaluation). 에볼루션 바카라사이트 Corporation's strategy is to rapidly assess the therapeutic potential in a patient population characterized by substantial unmet medical needs in real-world clinical practice.

"This Phase 2 clinical trial targeting CSU patients is designed to further validate the safety, efficacy, and clinical benefits of lesigercept across a broader patient population in Asian and European countries. It will represent another exemplary milestone in our global R&D expansion strategy driven by open innovation," said Kim Yeul-hong, president of R&D at Yuhan Corporation.

Lesigercept is a novel drug candidate based on an anti-IgE Fc fusion protein platform. It is designed with a dual mechanism of action, simultaneously binding and neutralizing circulating free IgE as well as autoantibodies targeting the IgE receptor alpha protein (FcεRIα), thereby alleviating allergic symptoms.