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FDA Accepts Phase 1 Clinical Trials of Exosome Therapy for AD


Brexogen Inc.’s exosome therapy is the first entry of a clinical trial of exosome treatment for atopic dermatitis.

The US Food and Drug Administration (FDA) has accepted Brexogen’s phase 1 clinical trial initiation of BRE-AD01, an exosome-based therapy treatment for atopic dermatitis (AD). Brexogen, a South Korean laboratory, is developing BRE-AD01 with its own exosome-platform technology. The trial is the first phase 1 trial of therapeutic exosome for AD across the globe.

BRE-AD01 is produced from stem cells stimulated with a specified, well-defined clinical available compound, which is a large component of Brexogen’s technology and developments. In previous preclinical models, positive therapeutic effects were demonstrated by BRE-AD01 compared to current competing drugs such as Janus Kinase (JAK) inhibitors. In the preclinical models using BRE-AD01 on animals, no adverse events were reported. Breoxgen is hopeful that BRE-AD01 will be successful in repressing type 2 immune reactions, regulating IL-31R, and promoting skin barrier recovery.

The Centers for Biologics Evaluation and Research of the FDA completed the review of Brexogen’s phase 1 clinical trial for BRE-AD01 on October 27, 2022, and confirmed the start of the phase 1 clinical trial. In the trial, patients with severe AD will receive BRE-AD01. The safety and therapeutic efficacy of the Investigator Global Assessment scale, Eczema Area and Severity Index, and SCORing Atopic Dermatitis tool will also be evaluated.

Found and CEO of Brexogen, Soo Kim, MD, is hopeful that exosome technology can be improved to a level that can be commercialized as a reliable option for AD treatment. Brexogen’s stem cell priming strategy will be used to accelerate the development of upcoming pipeline drugs using results from the BRE-AD01 clinical trial. Follow-up trials will be conducted after the successful completion of the phase 1 trial. According to Kim, exosome therapy still faces difficulties in development such as quality control and the manufacturing process.

Brexogen’s technology uses therapeutic cargo-controlled exosomes optimized for various diseases such as AD (BRE-AD01), myocardial infarction (BRE-MI01), and non-alcoholic fatty hepatitis (BRE-NA01).


  1. Brexogen’s exosome therapy for atopic dermatitis, “BRE-AD01” accepted for phase 1 clinical trials by US FDA. PR Newswire. Published November 6, 2022. Accessed November 7, 2022.
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