FDA granted IND clearance today for STI-9199 (COVISHIELD™) for a Phase 1 safety and pharmacokinetic study in healthy volunteers.
Initial trials are expected to be followed by a multinational Phase 2/3 trial in both mild and moderate COVID-19 patients.
STI-9199 has demonstrated in vitro and in vivo activity against all SARS-CoV-2 variants tested, including the Omicron strain BA.1, Omicron BA.1+R346K and Omicron BA.2.
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