Development of an inhaled biological agent for COVID-19

Purpose and goal:

Efficacy and toxicology studies conducted in COVID-19 animal models have demonstrated the impact and effectiveness of our 2MA1 drug candidate, manufactured to pre-GMP standards in collaboration with our biotech partner. Expected results and effects:

We optimized 2MA1 drug production, confirmed post-translational modifications, and designed an inhalation device with an industrial partner. Efficacy and toxicology studies in COVID-19 animal models and in vitro demonstrated drug impact. Dose-dependent mouse studies evaluated safety for clinical development. Establishing an ex vivo human lung platform enabled biodistribution and acute toxicity testing. Preclinical data analysis ensured regulatory compliance for clinical phases and biostatistics.

Approach and implementation:

Developing a universal strategy to impede SARS-CoV-2 infection is crucial for effective COVID-19 therapy. Using inhaled rhACE2 to neutralize the virus, our project pioneers a nebulized drug to mitigate lung damage and limit infection spread.

Our COVID-19 drug candidate, 2MA1, meets pre-GMP standards and shows efficacy in animal studies, with confirmed safety. Insights from studies in COVID-19 animal models inform our preparations for human trials, highlighting our commitment to scientific rigor and regulatory compliance.