Sorrento Therapeutics announced that the FDA has given the company the okay to move ahead with a Phase 1 trial of its Covishield (STI-9199) intranasal antibody cocktail in healthy volunteers. According to Sorrento, in vitro and in vivo studies of STI-9199 have demonstrated that the antibody cocktail has activity against multiple variants of SARS-CoV-2, including three strains of the Omicron variant.
Following completion of the Phase 1 study, Sorrento said, it expects to initiate Phase 2/3 trials in patients with mild and moderate COVID-19. The company also said that it “plans to discuss with the FDA the most appropriate end-points for the pivotal study that could result in an Emergency Use Authorization (EUA), if the trials meet the efficacy end-points of the pivotal study.”
A Phase 2 study of Sorrento’s CoviDrops (STI–2099) intranasal neutralizing antibody in patients with mild COVID-19 was initiated in July 2021.
Read the Sorrento Therapeutics press release.
