Sorrento Therapeutics, Inc.,today announced that COVID-19 patients have been dosed in its Phase 2 efficacy trial. Approximately 350 outpatients with COVID-19 who are asymptomatic or have mild symptoms will be enrolled in this large double-blind, randomized clinical trial evaluating COVIDROPS doses of 10 mg or 20 mg against placebo. This study uses a novel decentralized design where subjects are assessed and treated in their homes and received a rapid review and clearance from the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.
A previously completed safety study conducted in the US at doses up to 60 mg in healthy subjects showed a comparable safety profile to placebo all reported adverse effects being mild in severity. The UK study will complement Phase 2 trials currently being started in the US and, should the results of these studies demonstrate that COVIDROPS is both safe and effective against SARS-CoV-2, Sorrento will apply for Emergency Use Authorization in the US, UK, Canada, India, Mexico and European Union as well as other territories.
COVIDROPS is administered as a simple intranasal instillation into each nostril to recently infected subjects. The neutralizing antibody drug substance is the same antibody as in COVI-AMG, which is a high potency/low dose IV push injection. The antibody is active in vitro and in animal models of COVID-19 infection against the SARS-CoV-2 variants of concern (VoCs) currently infecting the UK and the US, including the highly transmissible and virulent India/Delta variant, as well as the UK/Alpha variant and the original SARS-CoV-2 virus.
Sorrento is developing a second neutralizing antibody with potential activity against all VoCs, including the Beta (South Africa) and Gamma (Brazil), for entry into the clinic and is intended for use as a cocktail for both intranasal and intravenous administration to augment the coverage of prevailing VoCs. Variants of interest, such as Lambda (Peru) and others are constantly evaluated in Sorrento’s active surveillance program.