BiondVax Pharmaceuticals announced statistically significant efficacy results in a preclinical in vivo proof-of-concept study of its innovative inhaled nanosized antibody COVID-19 therapy. Study design: Using an industry-standard animal model for COVID-19 therapeutics and vaccines, the study compared weight loss in two groups of hamsters after infection with SARS-COV-2. The first group was treated with BiondVax’s anti-COVID-19 NanoAb starting one day after being infected, while the second group was treated in the same manner but with saline serving as a placebo. Results: Compared to their weight immediately prior to infection, the control group’s weight declined on average 12.01%, while the weight of the experimental group, which was administered BiondVax’s NanoAb through inhalation, declined on average only 3.80%, a highly statistically significant result. The successful result was further supported by eight other tracked parameters, including heart rate and social behaviors, that indicated the group treated with inhaled NanoAbs experienced a milder and shorter illness. Amir Reichman, BiondVax’s CEO, added, "Recent papers have highlighted the limitations of existing therapeutics, in particular Paxlovid (Pfizer) in at-risk populations, the absence of monoclonal antibodies that are highly effective against Omicron, and the need for new improved treatments to prevent severe disease. On top of that, there is a decrease in uptake of COVID-19 vaccinations and boosters. We believe our inhaled NanoAb therapeutic can serve this unmet need with a patient-friendly route of administration directly to the original source of infection." Next steps: This preclinical trial will continue in January 2023. The study will also evaluate safety parameters. In 2023, BiondVax will conduct a pre-clinical toxicity study as required by regulatory authorities for approval of human clinical trials. The Company will also scale-up its manufacturing processes to produce, at its GMP manufacturing site in Jerusalem, the NanoAbs for the first-in-human Phase 1/2a clinical trial in patients which is planned for Q4 2023.
Published first on TheFly
