VT BIO said the company received approval to conduct clinical trials of its VT301 drug to treat Alzheimer's disease of antigen-specific self-regulated T cells by the U.S. Food and Drug Administration on Thursday.

This U.S. clinical trial is the second one to treat Alzheimer's disease using regulated T cells in the world after Korea. The approval is significant because it gave the go-ahead to phase 1 and 2a clinical trials simultaneously, and secured the freezing conditions, the biggest difficulty facing the cell therapy, according to VT Bio.

VT301, devoid of freezing conditions, is already in the clinical phase 1 trial process at Seoul National University Hospital and has confirmed its safety and pharmacokinetic characteristics. VT301S is an antigen-specific immunomodulatory cell with a mechanism of action that differentiates it from antibody therapeutics based on the beta-amyloid hypothesis.

The theory suggests that a complex factor causes Alzheimer's disease, and eventually, the immune imbalance caused by excessive immune activation in the brain causes Alzheimer's disease. Therefore, if this part is controlled, there can be better outcomes for Alzheimer's patients. More specifically, the therapy seeks to control and improve microglia, the brain's immune cells, using VT301S.

A company official explained that VT BIO plans to conduct clinical trials in the U. S. this year and is selecting hospitals, part of which has already been completed.

Although the possibility of success in treating Alzheimer's disease has increased due to the recent approval of Biogen's "Aduhelm," the effectiveness and adverse reactions of the treatment remain controversial, according to VT Bio.

However, it is a field with very high unmet demand, and the market size is increasing significantly due to population aging in major countries. Market research firm MARC predicts that the global market size will be $6.34 billion (about 7.9 trillion won) in 2020, growing at an average rate of 6.5 percent between 2021 and 2026.

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