First entry to clinical trial of exosome for atopic dermatitis and the first exosome-based therapeutics in US clinical trial among Korean companies
SEOUL, South Korea I November 2, 2022 – 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.”
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).