The atopic dermatitis treatment method "BRE-AD01" developed by Brexogen of South Korea using exosome platform technology was accepted for phase I clinical trials by the US FDA

The atopic dermatitis therapy "BRE-AD01" developed by Brexogen of South Korea using its own exosome platform technology was accepted by the US FDA for phase I clinical trials, and is the first atopic dermatitis therapy based on exosome platform technology to enter phase I clinical trials in major countries
.
Although it is a phase I clinical trial stage, the trial subjects are patients with atopic dermatitis, which is of great significance
.

"BRE-AD01" is an atopic dermatitis therapy
developed by Brexogen of South Korea using its own exosome platform technology.
The raw material is a combination of stem cells (BxC) suitable for the production of exosomes and hepatocyte immunosuppressive technology
.
In various preclinical models, "BRE-AD01" showed superior therapeutic efficacy
compared to competing drugs (Dupixent, JAK inhibitors, steroids).
Recently, JAK inhibitors approved to treat atopic dermatitis have had serious side effects
.
In contrast, "BRE-AD01" has never produced any side effects, but has a variety of MOAs (Mechanism of Action)
that help suppress the type II immune response, regulate IL-31R, promote skin barrier recovery, and improve the symptoms of atopic dermatitis.

According to Brexogen on October 27, the US FDA Center for Biologics Evaluation and Research (CBER) completed the review of the "BRE-AD01" phase I clinical trial and confirmed the start
of the phase I clinical trial.

In this clinical trial, patients with severe atopic dermatitis will receive "BRE-AD01" and evaluate its safety and efficacy of IGA, EASI and SCORAD
.

Kim Soo, representative of Brexogen, said: "I am delighted to be accepted by the US FDA for Phase I clinical trials
.
The exosome therapy developed in Korea is the first clinical study in patients with atopic dermatitis in the United States, and it is of great significance to greatly increase the potential of exosome technology in the research stage to a level that can be commercialized
.
We will use this clinical research opportunity to lay the foundation for the clinical development and commercialization of exosome therapeutics and accelerate the development of
the next pipeline.
" Exosome therapeutics are still facing difficulties in developing as new model drugs, but this time we see the possibility of global commercialization, so we will accelerate the next phase of clinical trials after successfully completing the first phase of clinical trials to provide exosome therapeutics
that can receive radical treatment for patients with atopic dermatitis.
"

He added, "We are working to commercialize
various products, including pharmaceuticals, using exosomes of different components developed through Brexogen exosome platform technology.
Starting with this clinical trial, the continued development of exosome products is expected to promote the company's growth
.
"