Exosystemtec Applies for Korea's First IND for Exosome-Based Therapeutic Candidate Phase 1 Clinical Trial

Osteoarthritis Treatment 'EST-P-EXO1'

[Asia Economy Reporter Lee Gwan-joo] A domestic bio venture has applied for the first clinical phase 1 trial using an exosome-based therapeutic.

Exostemtech announced on the 21st that it has submitted an Investigational New Drug (IND) application to the Ministry of Food and Drug Safety to conduct a domestic phase 1 clinical trial of its osteoarthritis treatment candidate ‘EST-P-EXO1’ (CARTISOME®).

In this domestic phase 1 trial, Exostemtech will evaluate the safety of EST-P-EXO1 in patients with knee osteoarthritis. The trial is planned to be conducted at Uijeongbu St. Mary's Hospital of The Catholic University of Korea with up to 28 patients.

EST-P-EXO1 is an osteoarthritis treatment candidate derived from human stem cell-derived exosomes. It contains regenerative factors and anti-inflammatory components from stem cells, which are known to have regenerative effects on cartilage tissue damaged by osteoarthritis and pain suppression efficacy through inflammation control.

Exostemtech will collaborate with Kolon Biotech to produce clinical-grade drugs for administration of EST-P-EXO1. The company explained that this is being carried out with support from the ‘Pharmaceutical Industry Full-Cycle Global Expansion Support Project: Bio Venture Contract Manufacturing Support Project’ led by the Korea Health Industry Development Institute, which was finalized this month.

An Exostemtech official stated, “EST-P-EXO1 can effectively improve inflammation and damaged tissue environments and can be applied to the treatment of various degenerative and inflammatory diseases,” adding, “We will expand its indications starting with osteoarthritis to include conditions such as liver fibrosis.”

This content was produced with the assistance of AI translation services.