PR98596

SEOUL, South Korea, Nov. 7, 2022 /PRNewswire=KYODO JBN/ --

First entry to clinical trial of exosome for atopic dermatitis

The first exosome-based therapeutics in US clinical trial among Korean companies

The US FDA granted the initiation of the phase 1 clinical trial of 'BRE-AD01',

an exosome- based therapy for atopic dermatitis. 'BRE-AD01' is being developed

by Brexogen with its own exosome-platform technology. It is the first phase 1

clinical trial of therapeutic exosome for atopic dermatitis in major countries.

This IND clearance is very meaningful in that patients with atopic dermatitis

can benefit from receiving better treatment with 'BRE-AD01', which is armed

with multiple mode of action.

'BRE-AD01' is produced from stem cells (named 'BxC') stimulated with a

specified, well-defined clinical available compound, which comprised the

backbone of Brexogen's technology. In various preclinical models, superior

therapeutic effects were demonstrated by BRE-AD01 compared to competing drugs

(Dupixent, JAK inhibitors, steroids). Recently, serious side effects have been

reported by patients that received JAK inhibitor, which was approved as an

innovative drug for the atopic dermatitis. In contrast, no side effect was

observed in BRE-AD0-received atopic dermatitis animals, with better therapeutic

efficacy. BRE-AD01 has multiple MOAs (such as repressing type 2 immune

reaction, regulating IL-31R, and promoting skin barrier recovery, contributing

to enhanced atopic dermatitis symptoms.

According to Brexogen Inc. on October 27, the Center for Biologics Evaluation

and Research (CBER), US FDA, completed the review of phase 1 clinical trial for

BRE-AD01 and confirmed the starting of the phase 1 clinical trial.

In this clinical trial, patients with severe atopic dermatitis will receive

BRE-AD01, and the safety and therapeutic efficacy of IGA, EASI, and SCORAD will

be evaluated as well.

Dr. Soo Kim, the CEO and co-founder of Brexogen Inc. said, "I am very happy to

hear our Phase 1 clinical trial was accepted by the US FDA. Conducting the

first clinical study on an exosome therapeutics developed from South Korea has

an important meaning in that the potential of exosome technology, which is

currently at the research level, can be greatly improved to a level that can be

commercialized as a reliable option. We will use our stem cell priming strategy

to accelerate the development of next pipeline using the results from this

clinical trial. After successful completion Phase 1 trial, we will conduct

follow-up clinical trials with the patients. However, exosome therapy is still

facing difficulties in development, but can be commercialized at a global level

once we overcome these issues (such as quality control and manufacturing

process). We will continue to provide a therapeutic exosome for several

indications."

Dr. Kim said, "We are making efforts to commercialize not only pharmaceuticals

but also various products using exosomes with different ingredients developed

through the Brexogen exosome platform technology. Starting from this clinical

trial, we will continue developing exosome products."

[Introduction] www.brexogen.com

Brexogen is a company established in 2019 by CEO Soo Kim, who has expertise in

stem cells and exosomes for more than 20 years. She established the BG-Platform

technology for developing exosome therapeutics to overcome the limitations of

current exosome therapeutics in quality control and mass production.

BG-Platform technology utilizes the therapeutic cargo-controlled exosome

optimized for various diseases such as atopic dermatitis (BRE-AD01), myocardial

infarction (BRE-MI01), and non-alcoholic fatty hepatitis (BRE-NA01).

Source: Brexogen