SRNE - Sorrento gets FDA nod to start early-stage trial for intravenous COVID-19 therapy

Sorrento Therapeutics (NASDAQ:SRNE) announced on Monday that the U.S. Food and Drug Administration (FDA) cleared its investigational new drug application (IND) to study intravenous STI-9167 (COVISHIELD) in healthy volunteers. The Phase 1 study will proceed at a single trial site in the U.S., followed by a global Phase 2/3 trials in the U.S., China and Mexico involving mild and moderate COVID-19 patients. STI-9167 is an IV formulation of the intranasal STI-9199. Previously, the FDA cleared IND for STI-9199, leading the company to draw up plans conduct a Phase 1 safety and pharmacokinetic study for the neutralizing antibody therapy in San Diego. It will be followed by a multinational Phase 2/3 trial in the U.S., U.K, and Mexico, the company said last month.

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Sorrento gets FDA nod to start early-stage trial for intravenous COVID-19 therapy