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Celltrion Group, based in South Korea, has submitted an Investigational New Drug (IND) application to conduct a global Phase III clinical trial evaluating the efficacy and safety of an inhaled COVID-19 antibody cocktail therapy for patients with mild-to-moderate symptoms of COVID-19; the trial is expected to enrol 2,200 patients globally.
The inhaled COVID-19 antibody cocktail is a combination of monoclonal antibodies with regdanvimab (CT-P59) and CT-P63 and has been developed to target newly emerging mutations of SARS-CoV-2, including the Omicron variant (B.1.1.529).
The global Phase III clinical trial proposed in the IND is designed to evaluate the safety and efficacy profile of the inhaled COVID-19 antibody cocktail.
The muco-trapping antibody platform used for the inhaled COVID-19 antibody cocktail directly traps the virus in airway mucus, preventing the local spread of the infection, and quickly eliminates the virus from the lungs through the body's natural ability to clear mucus.
Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare said, “Inhaled delivery substantially reduces the dose required to achieve a therapeutic effect compared to intravenous injections, thereby reducing the cost of treatment. An inhalable treatment can be self-administered in at-home settings, and at a scale not achievable using the conventional inpatient intravenous infusion treatments."
