Sorrento Therapeutics has dosed subjects in Phase II trial of its intranasal drug, COVIDROPS, for the treatment of Covid-19 in the outpatient setting in the UK.
A neutralising antibody drug substance, COVIDROPS is meant for being instilled into both nostrils of people who are recently infected.
The large double-blind, randomised Phase II efficacy trial will enrol a total of nearly 350 Covid-19 patients with mild symptoms or without symptoms.
Subjects will receive 10mg or 20mg doses of COVIDROPS or placebo.
Sorrento noted that the trial utilises a new decentralised design in which participants are analysed and treated in the at-home setting.
The trial was launched on obtaining a quick review and approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA).
In a safety trial carried out in the US, up to 60mg doses of COVIDROPS were found to have a safety profile in line with placebo in healthy participants.
Furthermore, the severity of all the adverse effects linked to the drug was observed to be mild.
The latest trial in the UK will complement Phase II trials being commenced in the US.
On obtaining positive safety and effectiveness data against Covid-19, Sorrento plans to seek emergency use authorisation in the US, the UK, Canada, India, Mexico and the EU, among other countries.
In animal and in vitro Covid-19 infection models, COVIDROPS was active against the original SARS-CoV-2 virus and the existing variants of concern (VoCs) in the US and the UK, including the Delta and Alpha variants.
The company is also developing another neutralising antibody to potentially act against all VoCs. Set to advance into the clinic, the second antibody is meant for intranasal and intravenous use.
Meanwhile, the Chinese National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) has approved Sorrento’s partner Escugen Biotechnology and its subsidiary Levena Biopharma’s application to begin a trial of TROP-2 ADC (ESG-401).
A recombinant humanised anti-trop2 Mab-SN38 conjugate, TROP-2 ADC (ESG-401) was co-developed by Escugen and Levena.