FDA clears Sorrento’s IND for Phase 1 trial of STI-2099 intranasal antibody against COVID-19

Sorrento Therapeutics said that the FDA has cleared its IND for a Phase 1 study of STI-2099 intranasal neutralizing antibody (CoviDrops) in healthy volunteers and in patients with mild COVID-19. The company said that it plans to study STI-2099 by itself or combined with an IV formulation of the antibody. In October 2020, Sorrento announced that STI-2099 reduced the duration of COVID-19 symptoms in a hamster model more than the IV formulation.

Sorrento Chairman and CEO Henry Ji commented, “We plan to use our intranasal formulation technology, which allows administering a drug via simple drops in the nose, for other antibodies we are currently developing with a goal of providing coverage against all variants of the SARS-CoV-2 virus that might evade inhibition from treatment with existing therapies.”

Read the Sorrento Therapeutics press release.

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