FDA Clears Phase 1 Trial of Sorrento’s Investigational COVID-19 Antibody
Sorrento Therapeutics has received FDA approval for a phase 1 trial of its monoclonal antibody, COVI-GUARD (STI-1499), for the treatment of hospitalized COVID-19 patients.
The trial will evaluate a single dose of the antibody vs. a placebo in 33 hospitalized patients with moderate COVID-19 infections to evaluate its safety, pharmacokinetics and efficacy. The study will test four different dose levels.
Sorrento said it hopes to file for an Emergency Use Authorization for the drug before the end of the year and plans to produce an initial 50,000 doses in anticipation of getting the authorization.