Celltrion submits Investigational New Drug (IND) application to initiate a global Phase III clinical trial evaluating an inhaled COVID-19 antibody cocktail therapy

Celltrion submits Investigational New Drug (IND) application to initiate a global Phase III clinical trial evaluating an inhaled COVID-19 antibody cocktail therapy

·          Celltrion submitted an IND application for a global Phase III clinical trial of inhaled antibody cocktail therapy with CT-P59 and CT-P63; the company expects to enrol 2,200 patients with mild-to-moderate symptoms of COVID-19

·          The inhaled COVID-19 antibody cocktail therapy and CT-P63 maintained strong neutralising ability against the Omicron variant (B.1.1.529)

·          The inhaled COVID-19 antibody cocktail directly traps virus in airway mucus and rapidly eliminates the virus from the lungs using the muco-trapping antibody platform

February 7, 2022, INCHEON, KOREA – Celltrion Group announced today it 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.

“We have accelerated development of our inhaled COVID-19 antibody cocktail therapy, leveraging our antibody platform to address the ongoing challenges of the pandemic” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “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. We are working diligently to increase access to effective and safe monoclonal antibodies that are convenient and cost-effective. We look forward to sharing additional updates on the progress of patient enrolment and global clinical trials in the coming months.”

Celltrion & Inhalon: inhaled formulation of CT-P59

In August 2020, Celltrion and Inhalon Biopharma signed a Confidential Disclosure and Material Transfer Agreement for the research and development of an inhaled administration formulation of regdanvimab. The companies received approval from the Therapeutic Goods Administration (TGA) of Australia to conduct a Phase I trial in 24 healthy volunteers. The study showed the inhaled formulation of regdanvimab (CT-P59) achieved an endpoint of safety and tolerability, and no serious adverse events (SAEs) related to treatment were reported.

Celltrion’s monoclonal antibody: CT-P63

Celltrion enrolled 24 healthy volunteers in a global Phase I clinical trial to evaluate the safety, tolerability and pharmacokinetics of CT-P63. The study showed CT-P63 to be safe and well tolerated, with no significant drug-related adverse events (AEs). CT-P63 showed strong neutralising activity against the Omicron variant based on structural analysis by X-ray crystallography and neutralisation data from pseudo-virus testing.