Celltrion races inhaled COVID-19 antibody therapy into phase 3 to counter omicron

Celltrion’s inhaled COVID-19 antibody cocktail therapy is moving into phase 3. Ten weeks after outlining plans to accelerate the program in response to omicron, Celltrion has filed an IND to study the therapy in a trial of 2,200 patients with mild to moderate symptoms of COVID-19.

Korea’s Celltrion struck a deal to access inhaled drug delivery technology from Inhalon Biopharma back in August 2020, leading to a phase 1 clinical trial of a nebulized formulation of the anti-SARS-CoV-2 drug regdanvimab. But the program ignited late last year when Celltrion responded to evidence that omicron evades existing antibody therapies by stepping up plans for an inhaled combination therapy. 

Since then, Celltrion has put the investigational molecule in the combination, CT-P63, through a phase 1 trial to assess its safety, tolerability and pharmacokinetics. That done, Celltrion is pushing ahead with the phase 3 study.

The global phase 3 clinical trial will enroll 2,200 patients with mild to moderate COVID-19 to assess the efficacy and safety of nebulized formulation of regdanvimab, sold in an infused form as Regkirona, and CT-P63 that is suitable for self-administration. Combining the two antibodies is intended to boost efficacy against omicron and potentially future variants that diverge further from the original strain.

RELATED: Omicron spurs Celltrion to speed development of nebulized drug

Celltrion sees multiple benefits to using a nebulizer to administer the two molecules. Using Inhalon’s muco-trapping platform, Celltrion aims to trap the virus in airway mucus. Trapping the virus could stop the local spread of the infection and enable the speedy elimination of the virus via bodily processes for clearing mucus. 

The switch from infused to inhaled drug delivery is also intended to enable self-administration, thereby cutting the burden on healthcare staff and facilities, and reduce the dosage needed to extend supplies to more patients.