GI Innovation Publishes Combination Therapy for Food Allergy Treatment in Nature Communications

[Asia Economy Reporter Chunhee Lee] GI Innovation and microbiome development company GI Biome announced on the 28th that they have published results proving the efficacy of IgETRAP (GI-301/YH35324) and Bifidobacterium longum probiotic combination therapy for food allergies in the world-renowned academic journal Nature Communications.

IgE is known as a major factor causing severe allergic diseases such as food allergies, asthma, chronic idiopathic urticaria, and atopic dermatitis. Currently, the only anti-IgE drug approved by the U.S. Food and Drug Administration (FDA) is Novartis's Xolair (generic name omalizumab), a blockbuster drug generating over 4 trillion KRW in annual global sales. It is used limitedly for asthma, chronic idiopathic urticaria, and nasal polyps.

Food allergies also affect approximately 240 million patients worldwide, and the market size is expected to reach 45 trillion KRW annually by 2027. The only FDA-approved drug for food allergies is also Palforzia by Aimmune Therapeutics. Although it is still limited to peanut allergies, this led to the global food company Nestl? acquiring Aimmune Therapeutics for about 3.6 trillion KRW in 2020.

The research teams of GI Innovation and GI Biome demonstrated the efficacy of IgETRAP and probiotics in mouse models of IgE-mediated egg and peanut allergies, the most common causes of food allergies. IgETRAP effectively binds to IgE and suppresses the secretion of the cytokine IL-33, which induces allergic symptoms, while Bifidobacterium longum probiotics induce apoptosis of already proliferated mast cells, reducing the number of mast cells related to allergic reactions. This explains the synergistic effect through different mechanisms of IgETRAP and Bifidobacterium longum probiotics in alleviating food allergy symptoms.

Furthermore, IgETRAP showed superior IgE binding and degranulation secretion inhibition compared to omalizumab. Currently, IgETRAP (YH35324/GI-301) has been licensed to Yuhan Corporation for 1.4 trillion KRW, and joint research and development are underway. This year, a single-dose phase 1 trial was completed, and a repeated-dose phase 1b clinical trial is planned.

Jang Myungho, CSO of GI Innovation and the corresponding author of this study, said, “It is very encouraging to be the first to confirm the combined effect of IgE inhibitors and microbiomes in food allergy models, which are increasing globally but lack adequate treatment options.” He added, “Especially, IgETRAP monotherapy is expected to show improved effects compared to existing anti-IgE treatments, and above all, it is hoped to provide hope to severe patients with high IgE levels, a large unmet need.”