Celltrion files IND for phase 3 trial of inhaled Covid-19 cocktail therapy

Celltrion Group (Celltrion Healthcare), a South Korean pharma company, has submitted an investigational new drug (IND) application to carry out a global phase 3 clinical trial of an inhaled Covid-19 antibody cocktail therapy made up of regdanvimab (CT-P59) and CT-P63.

The late-stage clinical trial will assess the efficacy and safety of the cocktail therapy in patients having mild-to-moderate symptoms of Covid-19.

Celltrion Group expects to enroll 2,200 patients around the world for the phase 3 Covid-19 clinical trial.

Both regdanvimab and CT-P63 are monoclonal antibodies, which have been developed for targeting newly emerging mutations of SARS-CoV-2, which include the Omicron variant (B.1.1.529).

According to Celltrion Group, the muco-trapping antibody platform in the inhaled Covid-19 antibody cocktail traps the virus directly in airway mucus, thereby stopping the local spreading of the infection, while quickly killing it from the lungs via the natural ability of the body to clear mucus.

Dr. HoUng Kim — Celltrion Healthcare Head of Medical and Marketing Division said: “We have accelerated development of our inhaled COVID-19 antibody cocktail therapy, leveraging our antibody platform to address the ongoing challenges of the pandemic.

“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.”