Exostemtech applies for phase 1 osteoarthritis trial

Exostemtech said it applied for a phase 1 trial of EST-P-EXO1, an osteoarthritis treatment candidate, to the Food and Drug Safety Ministry. If the company gets the nod for the study, EST-P-EXO1 will become the first exosome-based treatment that enters a clinical trial in Korea.

According to Exostemtech, EST-P-EXO1 is an experimental treatment based on exosomes extracted from human stem cells. As the drug contains stem cells’ regeneration factors and anti-inflammatory substances, it could effectively regenerate cartilage tissue damaged by osteoarthritis and suppress pain through inflammation control, the company said.

Exostemtech said it would work with Kolon Biotech, a contract manufacturing organization (CMO), to produce EST-P-EXO1 samples for the clinical trial. The manufacturing will be supported by the Korea Health Industry Development Institute’s (KHIDI) program to enhance pharmaceutical firms’ global advancement in all cycles, which picked Exostemtech as the final winner in April.

“EST-P-EXO1 can effectively improve inflammation and damaged tissues, and it can be applied to various degenerative and inflammatory diseases,” an official at Exostemtech said. “Starting with osteoarthritis, we will expand indications such as liver fibrosis.”

Exosomes are endoplasmic reticulum with 50-200 nanometers secreted by cells. They transfer information between cells. Exosome-based treatments have excellent drug delivery capability and regenerative therapeutic effects. In addition, they can be easily stored and distributed, industry officials said.

Source – Korea Biomedical Review

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