Exosome-Based Therapy for Atopic Dermatitis
The US FDA granted the initiation of the phase one 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 one 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.'
"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," said Soo Kim, M.D., the CEO and co-founder of Brexogen Inc.
'BRE-AD01's Superior Therapeutic Effect
'BRE-AD01' is produced from stem cells stimulated with a specified, well-defined clinical available compound. In various preclinical models, superior therapeutic effect were demonstrated by BRE-AD01 compared to competing drugs. Recently, side effects have been reported by patients that received JAK inhibitor, which was approved as a drug for the atopic dermatitis.
In contrast, no side effect was observed in BRE-AD01-received atopic dermatitis animals, with an increased therapeutic efficacy. BRE-AD01 has multiple MOAs (such as repressing type two immune reaction, regulating IL-31R and promoting skin barrier recovery, contributing to enhanced atopic dermatitis symptoms.)
According to Brexogen Inc. on Oct. 27, 20222 the Center for Biologics Evaluation and Research (CBER), US FDA, completed the review of phase one clinical trial for BRE-AD01 and confirmed the start of the phase one 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 also be evaluated.