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Sorrento Announces Completion of Enrollment in US Phase 2 Clinical Trial for COVI-DROPS and Achievement of Interim Analysis Threshold in the UK

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Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) today announced that the US Phase 2 study (www.ClinicalTrials.gov  NCT04906694) with intranasal COVI-DROPS treatment in COVID-19 outpatients has completed enrollment. This preliminary efficacy study enrolled 72 adult outpatients who received a single administration of 10 mg, 20 mg or 40 mg COVI-DROPS or placebo, randomized 1:1:1:1. The primary endpoint was viral load reduction from baseline. Key secondary endpoints included the proportion of subjects with medically-attended visits or hospitalizations and the change from baseline in the WHO Clinical Progression Scale score. There were no significant safety events reported during this study.

Additionally, Sorrento is pleased to announce that the UK Phase 2 study (www.ClinicalTrials.gov  NCT04900428) of intranasal COVI-DROPS treatment in COVID-19 outpatients who are asymptomatic or have mild symptoms has reached the interim analysis threshold of 50% enrollment (n=175). In this study, outpatient adults received a single instillation of 10 mg or 20 mg COVI-DROPS or placebo with a randomization of 2:2:1. The primary efficacy endpoint in the UK study is viral load reduction from baseline and key secondary endpoints also are similar to the US study. Unlike the US study, this study uses a decentralized design where patients are assessed and treated in their homes. COVI-DROPS has also been well tolerated in this study.

We anticipate reporting on the results from both the US trial and the interim analysis of the UK trial in the coming months. The results of these Phase 2 trials will be combined with the results from the planned Phase 2 trials in Mexico which enrolls children as well as adults.

In contrast to some of the current EUA approved high dose neutralizing antibodies given by IV infusion or subcutaneous injection, COVI-DROPS is administered as a simple intranasal instillation into each nostril to recently infected subjects. The neutralizing antibody (nAb) in COVI-DROPS is the same antibody as in COVI-AMG, which is a high potency/low dose IV push injection. This nAb was active in vitro and in animal models of COVID-19 infection against the SARS-CoV-2 variants of concern (VoCs) including the highly transmissible and virulent India/Delta variant, as well as the UK/Alpha variant and the original SARS-CoV-2 virus.

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