BioLeaders Signs CRO Contract for Clinical Trial of 'BLS-H01' COVID-19 Treatment

by Ryu Hyunseok

Published 19 Mar.2020 11:13(KST)

[Asia Economy Reporter Yoo Hyun-seok] BioLeaders, a company specializing in new drug development and pharmaceuticals, announced on the 19th that it has signed a contract with CRO (Contract Research Organization) C&R Research for clinical trials of a COVID-19 treatment. Contract Manufacturing Organization (CMO) responsibilities will be handled by Korea Kolmar.

BioLeaders is attempting a 'drug repurposing' approach by testing its new drug candidate, the antiviral disease treatment ‘BLS-H01’, as a COVID-19 treatment. C&R Research is an institution with clinical experience in MERS (Middle East Respiratory Syndrome) treatments.

BLS-H01, developed by BioLeaders, is a treatment for cervical epithelial dysplasia caused by human papillomavirus (HPV). It has already successfully completed Phase 1 clinical trials verifying drug safety and Phase 2 trials confirming efficacy, and has also received approval for the Investigational New Drug (IND) application for large-scale Phase 3 clinical trials. The key substance of BLS-H01, poly-gamma-glutamic acid (γ-PGA), possesses strong antiviral functions by utilizing the autoimmune system.

After absorption into the body, BLS-H01 binds to TLR4 (Toll-like receptor 4), an innate immune receptor and autoimmune activation sensor, promoting the secretion of interferon-beta (IFN-β) and activating the body's immune system, including NK (natural killer) cells, to suppress or treat infections caused by specific bacteria or viruses.

Based on results from a 2013 experiment targeting SARS (Severe Acute Respiratory Syndrome), where the group administered poly-gamma-glutamic acid showed over 60% greater viral infection suppression compared to the control group, the company expects significant efficacy in treating COVID-19 as well. Especially with the periodic emergence of new viruses through RNA mutations leading to skepticism about vaccine development, immune therapies utilizing the autoimmune system are emerging as fundamental treatment methods.

Park Young-chul, CEO of BioLeaders, stated, “BioLeaders has over 20 years of experience and research know-how in treating virus-related diseases. In the current situation where there are no COVID-19 treatments or vaccines, if the early-stage viral cell death is confirmed using the autoimmune therapy BLS-H01, it will mark a new turning point in COVID-19 treatment.”