BiondVax announced additional results in a preclinical proof-of-concept study of its inhaled NanoAb COVID-19 drug. The study compared weight loss in two groups of hamsters. Hamsters administered a mid-sized 0.66mg dose of the NanoAb three hours prior to infection experienced no significant weight loss over the six-day trial, whereas the untreated control group’s weight declined 12% on average, a highly statistically significant difference. These prophylactic results follow previously reported data from the same study indicating that compared to the control group, hamsters treated with a 2mg dose of BiondVax’s inhaled NanoAb one day after infection had negligible SARS-CoV-2 viral titers in their lungs, and experienced a milder and shorter illness in comparison to the placebo group that had at least 30-times higher viral titers in their lungs at the end of the trial. Lung histopathology revealed that therapeutic inhalation of NanoAbs reduced damage to alveoli, pulmonary vessels, and the conductive system. This preclinical trial is continuing with additional arms testing lower therapeutic doses. The study will also evaluate safety parameters. In 2023, BiondVax is expected to conduct a preclinical toxicity study to assess safety as required by regulatory authorities for approval of human clinical trials. The company is also expected to scale up its manufacturing processes to produce the NanoAbs for the first-in-human Phase 1/2a clinical trial, planned for 4Q23.
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