ILIAS Biologics has obtained approval from Australia’s Human Research Ethics Committee (HREC) to commence the first-in-human Phase I clinical trial of ILB-202 to treat cardiac surgery-associated acute kidney injury (CSA-AKI).

Developed using the company’s EXPLOR platform, ILB-202 is an exosome therapy and contains anti-inflammatory protein super-repressor lκB (srlκB).

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It is intended to weaken inflammatory responses in several disease models by introducing srlκB to hinder NF-κB translocation into the nucleus. 

ILIAS is claimed to be the first Korean firm to advance exosome-based therapeutics to global trial. 

This trial will assess the safety and tolerability of ILB-202 in healthy adult subjects.

ILIAS Biologics co-CEO Chulhee Choi said: “With the approval to initiate the first-in-human clinical trial of ILB 202, we are one step closer to developing novel exosome-based therapeutics to help patients in need. 

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“ILIAS has proven the efficacy of ILB-202 in multiple inflammation-related therapeutic areas via proof-of-concept studies. 

“Starting with AKI, we plan to expand the indications of ILB-202 and look forward to providing millions of patients suffering from inflammatory diseases with an effective new treatment.”

The therapeutic efficacy of the company’s anti-inflammatory exosomes to treat ischemia reperfusion injury-AKI (IRI-AKI) was demonstrated earlier. 

Furthermore, the systemic administration of anti-inflammatory exosomes into preclinical IRI-AKI mouse models showed to substantially reduce AKI-associated biomarker levels in the blood, i.e., blood urea nitrogen, creatine and neutrophil gelatinase-associated lipocalin.

Currently, there exists no approved drug that offers clear therapeutic benefits for AKI, which is characterised by a fast reduction in kidney function. It can be caused by a variety of conditions, such as acute tubular necrosis and interstitial nephritis.