On Mar. 2, 2022, Sorrento Therapeutics announced that its Phase I study of intranasal (IN) STI-9199 (COVISHIELD^TM IN) has been fully enrolled in healthy volunteers. The study is currently still blinded and ongoing.

The safety profile of STI-9199 (COVISHIELD^TM IN) to date is similar to Sorrento’s Phase II compound STI-2099 (COVIDROPS^TM) with only transient adverse events, mild in severity and requiring no treatment. This was expected given that in nearly 300 patients treated with COVIDROPS^TM, a benign safety profile was also observed.

The Phase II/III studies are expected to be conducted in several countries (USA, China and Mexico). Sorrento plans to discuss with the FDA and other regulatory authorities the most appropriate end-points for the pivotal study that could result in an EUA, assuming the trials meet the efficacy end-points of the pivotal study.

The neutralizing antibody of STI-9199 is delivered as drops into the nose and, unlike most of the EUA-approved intravenously administered neutralizing antibodies, it has demonstrated in vitro and in vivo activity against the Omicron BA.2 variant, as well as all other SARS-CoV-2 variants of concern.

This intranasal approach has the potential to target Omicron in the upper airways and lungs. Although several neutralizing antibodies were shown to be quite effective during the initial outbreak of COVID-19, the initially EUA-cleared antibodies have had to be withdrawn from the market due to their lack of activity against the Omicron variants, and only a single EUA antibody, delivered by intravenous injection, is still available on the market for COVID-19 patients in need.