Guangzhou-based Bio-Thera Solutions (SHA: 688177) has announced the completion of all dosage groups (from 100 mg to 1500 mg) in a Phase I clinical study for its BAT2022. The results of the study demonstrated good safety across all dosage groups.
BAT2022: Drug Overview
BAT2022 is a bispecific neutralizing antibody against COVID-19 (SARS-CoV-2) developed by Bio-Thera using its proprietary phage display technology and single-domain antibody library. The drug targets two different important epitopes to reduce the risk of virus escape, offering a broad-spectrum and highly efficient neutralization capability. Preclinical studies have shown that BAT2022 has high neutralization ability against various major mutant strains of COVID-19, including Alpha, Beta, Gamma, Delta, and various Omicron subvariants, with an IC50 value ranging from 20 to 160 pM.
Efficacy and Neutralization
For the BA.2.76 variant, which has been detected in some parts of China, the neutralization titer of BAT2022 reaches 30 pM. Pharmacodynamic results from in vivo mouse models demonstrated that BAT2022 was highly effective in both prevention and treatment. The drug completely prevented weight loss in mice, inhibited viral replication in lung tissue, and reduced viral titers in lung tissue to below the lower limit of detection.
Future Outlook
The completion of the Phase I clinical study marks a significant milestone in the development of BAT2022. The strong safety profile and high neutralization ability shown in preclinical and early clinical studies position the drug as a promising candidate for addressing the ongoing challenges posed by COVID-19 and its variants.-Fineline Info & Tech
