Yuhan Corporation Presents Phase 1 Results of Allergy Drug 'YH35324' at European Conference

"Confirmed Inhibitory Effect on Immunoglobulin E"

Yuhan Corporation announced on the 12th that it presented the results of the Phase 1a Part A clinical trial of 'YH35324,' a new drug under development for the treatment of allergic diseases, on the 10th (local time) at the European Academy of Allergy and Clinical Immunology (EAACI).

Exterior view of Yuhan Corporation headquarters.
[Photo by Yuhan Corporation]

YH35324 is a fusion protein drug targeting immunoglobulin E (IgE)-mediated allergic diseases such as chronic spontaneous and inducible urticaria, atopic dermatitis, allergic asthma, and food allergies. IgE is one of the antibodies produced by the human immune system to defend against external attacks and is involved in allergic reactions such as itching, runny nose, and sneezing. YH35324 works by lowering the level of free IgE in the blood, thereby improving allergic symptoms.

The European Academy of Allergy and Clinical Immunology is a prestigious academic conference attended annually by about 10,000 allergy disease experts worldwide. At this conference, Professor Ye Young-min from the Department of Allergy at Ajou University Hospital presented the clinical trial results conducted at four domestic university hospital allergy departments during the poster presentation session of the annual meeting.

This clinical trial was a First-In-Human Phase 1a Part A study administering YH35324 to healthy individuals with atopy or patients with mild allergic diseases for the first time. The drug was given as a single dose with a stepwise dose escalation to evaluate safety, pharmacokinetics, and pharmacodynamic characteristics.

Professor Ye Young-min of Ajou University Hospital explained, "YH35324 showed excellent tolerability and safety at all doses, and pharmacokinetically, dose proportionality was observed. The drug reached a reduction in the key pharmacodynamic biomarker, free IgE in the blood, faster than the placebo and active control groups, confirming a strong and sustained IgE suppression effect."

Kim Yeol-hong, Head of Research and Development (R&D) at Yuhan Corporation, stated, "YH35324 demonstrated a favorable safety profile and potential as a therapeutic drug. We are currently conducting a Phase 1b clinical trial to evaluate safety, pharmacokinetics, and pharmacodynamics with repeated dosing, and preparing a Phase 1 clinical trial for preliminary proof of concept in patients with chronic urticaria." He added, "Based on various preliminary trial results, we expect to establish a more successful Phase 2 clinical trial plan."

YH35324 is a new drug technology introduced by Yuhan Corporation from GI Innovation in July 2020, and joint research and development are currently underway. The code name used by GI Innovation is GI-301.

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