Sorrento Therapeutics Inc (SRNE)

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Sorrento Announces FDA Authorization to Proceed With Phase 1 Study Of Intranasal STI-9199 (COVISHIELD), a Potent Neutralization Antibody Against Covid-19 Viruses
March 2, 2022 at 11:24 AM EST
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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.
SAN DIEGO, March 02, 2022 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced that it has received clearance from the FDA for its investigational new drug application (IND) for intranasal (IN) STI-9199 (COVISHIELD) to study the safety and pharmacokinetics in healthy volunteers.

The Phase 1 study will be at a single clinical site in San Diego and will be followed by multinational (USA, UK and Mexico) Phase 2/3 trials. Sorrento 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.