Bioreaders is drawing attention from the industry as it has been approved by the Ministry of Food and Drug Safety for a domestic phase 2 clinical trial for an oral COVID-19 treatment.
BioLeaders announced on the 22nd that it had received approval from the Ministry of Food and Drug Safety for a phase 2 clinical trial IND (clinical trial plan) for ‘BLS-H01 (ingredient: polygamma-glutamic acid)’. Bioreaders submitted a phase 2 IND in December last year.
BioReaders plans to evaluate the efficacy and safety of BLS-H01 compared to placebo in 100 patients with moderate COVID-19 in the second phase. It is a multicenter, randomized, double-blind, placebo-controlled, parallel group approach. The clinical trial institution is Pusan National University Yangsan Hospital.
However, it is understood that BioReaders applied for a clinical design change earlier this month, but the contents related to the co-administration were not reflected. In the meantime, Bioreaders has announced that it will change the phase 2 design so that BLS-H01 can be used together with remdesivir or paxrovid.
According to the protocol published by the Ministry of Food and Drug Safety, clinical participants will take the clinical trial drug (test drug or placebo) once a day for 14 days.
BioReaders said in a public notice, “The antiviral effect of BLS-H01 is different from that of a previously licensed or under development treatment. A substance that stimulates TLR4 present on the cell surface and promotes the secretion of IFN-β through signal transduction, activates immune cells, produces antiviral proteins, inhibits virus replication, and kills virus-infected cells ” he emphasized.