Yuhan Corporation Receives MFDS IND Approval for Phase 2 Clinical Trial of Novel Allergy Drug 'Lesigercept'

Administered for 12 Weeks to 150 Patients with Chronic Spontaneous Urticaria

Yuhan Corporation announced on October 15 that it has received approval from the Ministry of Food and Drug Safety for the Phase 2 clinical trial plan (IND) of Lesigercept (development code YH35324).

Seoul Dongjak-gu Yuhan Corporation Headquarters View. Yuhan Corporation

Lesigercept is a novel Fc fusion protein drug in the anti-immunoglobulin E (IgE) class. It improves allergic symptoms through a dual mechanism of action by binding to and eliminating both free IgE in the blood and IgE receptor alpha protein autoantibodies.

Yuhan Corporation previously confirmed the safety and preliminary proof of concept for Lesigercept through three Phase 1 clinical trials. The Phase 1 results showed that Lesigercept demonstrated a stronger and more sustained suppression of free IgE in the blood compared to the control drug in patients with chronic spontaneous urticaria, and exhibited superior activity in the UAS7 (7-day urticaria activity score) assessment, a key indicator for chronic urticaria, compared to the control group.

Notably, both patients with no prior experience of omalizumab treatment and those who did not respond to omalizumab showed a significant reduction in UAS7 scores from baseline, indicating overall symptom improvement. These trial results suggest that Lesigercept has the potential to overcome the therapeutic limitations of omalizumab in the treatment of chronic spontaneous urticaria.

The Phase 2 clinical trial will administer Lesigercept or placebo to 150 patients with chronic spontaneous urticaria over a 12-week period. The trial aims to evaluate safety and efficacy, and will be conducted as a multinational clinical study in countries across Europe and Asia, including South Korea.

Kim Yeolhong, Head of Research and Development at Yuhan Corporation, stated, "This Phase 2 clinical trial targeting patients with chronic spontaneous urticaria aims to confirm the safety, efficacy, and clinical advantages of Lesigercept in a broader patient population across Asian and European countries," adding, "It will be another successful example of Yuhan Corporation's strategy to expand global research and development through open innovation."

Lesigercept is a new drug introduced by Yuhan Corporation from GI Innovation in July 2020, and Yuhan Corporation holds the global rights excluding Japan.