Yuhan ‘confirms the safety and efficacy of its allergy drug

Publishes results in the SCI journal, International Immunopharmacology journal

Confirmed sustained IgE suppression effect compared to placebo or omalizumab

Yuhan Corp announced on Tuesday that the results of the Phase 1a clinical trial of its allergy drug candidate YH35324 were published in the SCI-ranked International Journal of Immunopharmacology.

 

YH35324 is a novel anti-immunoglobulin E (Anti-IgE) class Fc fusion protein drug.

 

Its main mechanism of action improves allergy symptoms by reducing the level of free IgE in the blood.

 

The Phase 1a clinical trial was the first time YH35324 was administered to humans (First-In-Human (FIH)).

 

The study was conducted from September 2021 to January 2023 in allergy medicine departments of 4 Korean university hospitals and included a total of 68 patients.

 

The study was conducted in two parts: Part A evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single dose of YH35324 in a stepwise dose escalation manner compared to placebo or omalizumab 300 mg.

 

Part B evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single dose of YH35324 or omalizumab in patients with elevated serum total IgE levels (>700 IU/mL).

 

Results demonstrated that YH35324 was well tolerated and safe at all doses, and was pharmacokinetically dose proportional.

 

Also, YH35324 demonstrated more potent and sustained IgE inhibitory activity compared to placebo or omalizumab on serum-free IgE, a key pharmacodynamic biomarker.

 

The notable factor was that Part B results demonstrated an excellent safety profile and more potent and sustained serum-free IgE inhibition compared to existing therapies, even in patients with elevated serum total IgE levels (>700 IU/mL).

 

Part A top-line results from the Phase Ia study were previously presented at the 2023 European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress last year.

 

The top-line results of Part B top-line will be presented as a poster at the American Academy of Allergy, Asthma and Immunology (AAAAI) 2024 Annual Meeting this year.

 

Dr.

 

Hae-Sim Park, Professor of Allergy at Ajou University Hospital, who was the corresponding author for the paper, said, “YH35324 is an anti-IgE trap (Fc fusion protein).

 

Not only was this trial the first successfully completed multicenter trial by Korean multicenter researchers, but it also showed encouraging results.

 

We look forward to YH35324 being developed as a new treatment for patients with allergic diseases worldwide." Yeol-Hong Kim, R&D President of Yuhan Corp, said, “We are currently conducting a Phase 1b trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of YH35324 in repeated doses in healthy individuals with atopic dermatitis or patients with mild allergies, and will soon begin evaluating YH35324 in patients with moderate-to-severe atopic dermatitis.” Yuhan Corp licensed in the technology for YH35324 from GI Innovation in July 2020.

 

The candidate substance is currently being researched and developed in collaboration with the two companies.

 

Its global rights outside of Japan are held by Yuhan Corp, and GI Innovation transferred the Japanese sales rights for the drug to Maruho, a leading Japanese dermatology company, in October 2023.