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.

HiFiBio submits IND for SARS-CoV-2 treatment
HiFiBio Therapeutics has submitted an investigational new drug (IND) application with the U.S. Food and Drug Administration for novel SARS-CoV-2 neutralizing...

HiFiBio partners with CoVIC for SARS-CoV-2 antibody therapies
HiFiBio Therapeutics and the Coronavirus Immunotherapy Consortium (CoVIC) will collaborate to develop SARS-CoV-2-neutralizing antibodies with potential...