Intranasal Coronavirus Neutralizing Antibody Launches Phase 2 Study
California-based Sorrento Therapeutics, Inc. announced today that COVID-19 patients had 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.
COVIDROPS is administered as a simple intranasal dose into each nostril to recently infected subjects.
This clinical 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, with all reported adverse effects being mild in severity.
The UK study will complement Phase 2 trials currently being started in the USA, 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 USA, UK, Canada, India, Mexico, and European Union as well as other territories.
The neutralizing antibody drug substance is the same antibody as in COVI-AMG, a high potency/low dose IV push injection.
The antibody is active in vitro and animal models of COVID-19 infection against certain SARS-CoV-2 variants of concern.
Sorrento is a clinical-stage, antibody-centric biopharmaceutical company developing new therapies to treat cancers and COVID-19.