HiFiBio discovered, engineered, and developed the candidate in less than six months. The company submitted an investigational new drug application with the U.S. Food and Drug Administration on August 25 and is planning a phase I clinical trial in the U.S. in the coming months. The phase I study will be followed by global late-stage trials in COVID-19 patients in late 2020.
Together, HiFiBio and ABL Bio will rapidly advance the candidate through clinical development. HFB30132A binds the SARS-CoV-2 spike protein with high affinity and is expected to have fewer adverse events and high distribution to lung and mucosal tissues than other traditional therapeutic monoclonal antibodies, according to HiFiBio.
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