Yuhan Corporation announced on the 21st that the full results of the Phase 1a clinical trial of YH35324, an allergy treatment under development, were published on the 20th in the SCI-level international journal International Immunopharmacology.
YH35324 is a new drug candidate originally developed by GI Innovation under the development code GI-301. Yuhan Corporation acquired the global rights excluding Japan from GI Innovation in July 2020. The Japanese rights were transferred by GI Innovation to Maruho in Japan in 2023.
YH35324 is an anti-immunoglobulin E (IgE) class crystallizable fragment (Fc) fusion protein drug. When the immune system of allergy patients is exposed to external triggers causing the disease, antibodies such as IgE are formed to block them. When these antibodies activate mast cells, the histamine levels in the cells increase, causing allergic reactions such as itching, runny nose, and sneezing. YH35324 binds to these antibodies and inhibits mast cell activation, thereby improving allergy symptoms.
The current clinical trial, which administered YH35324 to humans for the first time, was conducted as a Phase 1a study. Phase 1 trials are divided into Phase 1a, where a single dose of various drug amounts is administered, and Phase 1b, where multiple doses of various amounts are given.
This Phase 1a trial was conducted at the allergy departments of four university hospitals in Korea?Seoul Asan Medical Center, Severance Hospital, Bundang Seoul National University Hospital, and Ajou University Hospital?targeting 68 healthy individuals with atopy or mild allergic diseases. After a single dose of YH35324 was administered using a stepwise dose escalation method, safety, tolerability, pharmacokinetics, and pharmacodynamic characteristics were evaluated in Part A by comparison with placebo or the existing allergy treatment Xolair (active ingredient omalizumab) 300 mg. Part B was conducted to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics after a single dose of YH35324 or Xolair was administered to patients with elevated IgE levels. Part B aimed to assess these characteristics in patients with increased IgE levels.
As a result, YH35324 demonstrated excellent tolerability and safety at all doses and showed dose proportionality pharmacokinetically. Additionally, it exhibited stronger and more sustained IgE suppression activity compared to placebo or omalizumab against the key pharmacodynamic biomarker, free IgE in the blood. The company emphasized that especially in Part B, patients with elevated IgE levels showed an excellent safety profile and stronger, more sustained free IgE suppression activity compared to existing treatments.
The main results of Part A of this Phase 1a trial were presented at the European Academy of Allergy and Clinical Immunology (EAACI) 2023 Annual Meeting held last year, and the main results of Part B will be presented as a poster at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2024 Annual Meeting to be held in Washington, USA, from the 23rd to the 26th (local time).
Professor Haesim Park, corresponding author of this paper and an allergy specialist at Ajou University Hospital, said, "This clinical trial was not only successfully completed for the first time by domestic multi-center researchers but also showed very encouraging results," adding, "We expect YH35324 to be developed as a new treatment for allergy patients worldwide in the future."
Kim Yeolhong, President of Research & Development (R&D) at Yuhan Corporation, also stated, “The fact that it showed potential as a therapeutic drug even in patients with elevated IgE levels is a differentiating factor compared to existing treatments,” and added, “We are making every effort to prepare for a successful entry into Phase 2 clinical trials.”
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