August 26, 2020 -- HiFiBio Therapeutics has submitted an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for novel SARS-CoV-2 neutralizing antibodies for the treatment of COVID-19 patients.
The differentiated antibody, Hfb30132A, has been developed with the company's single-cell profiling platform and evaluated in multiple preclinical studies. The anti-SARS-CoV-2 recombinant antibody is designed with specific sequences identified from B cells of a COVID-19 convalescent patient.
Hfb30132A binds to the viral spike protein and neutralizes several mutated strains of the virus, including the mutant D614G. The company expects the product to be used as a monotherapy for treatment and prevention against SARS-CoV-2.
Within the next six months HiFiBio expects to begin a phase I single-intravenous administration ascending dose clinical trial will assess the safety, tolerability, and pharmacokinetics of the products in healthy volunteers.
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