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