The UK Medicines and Healthcare products Regulatory Agency (MHRA) has permitted Sorrento Therapeutics to commence a Phase II efficacy trial of its product candidate, COVI-DROPS, to treat Covid-19 in the outpatient setting.
Administered intranasally, COVI-DROPS contain a neutralising antibody that potentially works against the original SARS-CoV-2 virus and the UK/Alpha and India/Delta variants.
Sorrento submitted the Phase II trial application through a rolling submission approach and received MHRA clearance in under a month from its first filing with the regulatory agency.
The submission was backed by the safety data from a US study in healthy subjects, where the product candidate demonstrated a safety profile comparable to placebo with doses of up to 60mg.
Furthermore, no serious adverse effects or dose-limiting toxicities were noted in the study, with all adverse effects being mild.
The company noted that the maximum tolerated dose was not reached.
The large, randomised, double-blind, Phase II efficacy trial will enrol 350 asymptomatic or mildly symptomatic outpatients with Covid-19.
Participants will be categorised in a 2:2:1 ratio to receive either a 10mg or 20mg dose of the product or placebo.
Sorrento noted that the latest trial will support a Phase II study in the US and a separate trial in Mexico.
The Phase II efficacy trial results in the UK will be merged with the data from the US and Mexico studies.
If COVI-DROPS is found to be safe and effective against SARS-CoV-2, Sorrento plans to seek emergency use authorisation in the US, India, UK, Mexico, EU, and other regions.
In a separate development, the US Food and Drug Administration (FDA) has accepted the investigational new drug (IND) application of Vicore Pharma’s lead candidate, C21, for treating Covid-19.
The active IND aids in commencing Phase III ATTRACT-3 trial of the angiotensin II type 2 receptor (AT2R) agonist at various centres in the US.