Brexogen Initiates Phase 1 Clinical Trial of Myocardial Infarction Exosome Therapy with U.S. FDA Approval

Brexogen has initiated clinical trials for its myocardial infarction treatment developed using its proprietary platform technology.

On May 13, Brexogen announced that its exosome-based myocardial infarction treatment 'BRE-MI', developed using its exosome platform technology, has received approval for a Phase 1 Investigational New Drug (IND) application from the U.S. FDA, and is set to begin Phase 1 clinical trials in the United States. This marks the first time a myocardial infarction exosome therapy developed by a Korean company has entered a Phase 1 clinical trial in a major country. Although this is an early-stage study, it is significant in that the trial will be conducted with myocardial infarction patients.

With the entry of its second pipeline, the myocardial infarction exosome therapy 'BRE-MI', into clinical trials following its first pipeline, the atopic dermatitis exosome therapy 'BRE-AD01', Brexogen now holds the fastest development speed and the largest clinical pipeline among domestic exosome-based therapy companies.

'BRE-MI' is a myocardial infarction treatment based on exosomes (BxC-R11e) produced from tissue-regeneration-enhanced stem cells (BxC-R11), which have been primed with substances known for their cardioprotective efficacy. According to the company, preclinical studies in both small and large animals confirmed the drug's ability to promote cardiac regeneration, including protection and proliferation of cardiomyocytes, anti-inflammatory and anti-fibrotic effects, and promotion of microvascular formation. Furthermore, the administered exosomes were shown to enhance blood flow within the heart, distribute evenly in damaged tissue, and induce organic interactions between surrounding cells, thereby contributing to the recovery of reduced cardiac function.

In November of last year, Brexogen signed a joint development agreement for 'BRE-M' with KCRN Research, a clinical research organization (CRO) based in Maryland, USA, and received an upfront payment of 1 billion won. The two companies plan to leverage close collaboration to successfully conduct the upcoming clinical trial.

Kim Soo, CEO of Brexogen, stated, "As an exosome-based myocardial infarction therapy, we will do our utmost to demonstrate safety and efficacy in the global clinical environment and develop this as a treatment capable of fundamentally restoring damaged cardiac function."