Celltrion Inc. has confirmed the safety of its antibody candidate CT-P63 in the treatment of Covid-19 and variants including Omicron during its Phase 1 clinical trial, paving the way for its broader global trials.

Phase I clinical trial of CT-P63 was conducted with 24 healthy subjects in Poland, and no significant drug- related adverse events (AEs) were found, the South Korean pharmaceutical giant announced on Monday.

CT-P63 also showed a strong neutralizing activity against the surging Omicron variant according to neutralization data from pseudovirus testing in an experiment Celltrion had conducted in partnership with the National Institutes of Health (NIH) in the United States to evaluate its efficacy, according to Celltrion. Pseudoviruses are not real viruses and can be used as safe substitutes in tests because they cannot replicate and carry out an infection.

CT-P63 is one of 38 potent neutralizing antibodies against SARS-CoV-2 that have been identified by Celltrion. CT-P63, antibody candidate No. 32, produced high neutralization ability against new emerging strains, the company said.

The company plans to use CT-P63 in combination with Regkirona, an antibody treatment developed by Celltrion that received marketing authorization from the European Medicines Agency (EMA) last year. The cocktail therapy of CT-P63 and Regkirona is expected to be effective in the treatment of an even broader range of Covid-19 variants, the company said.

Following the successful Phase 1 trial, Celltrion plans broader global clinical trials for a nebulized cocktail therapy (CT-P63 in combination with Regkirona) with major regulatory agencies worldwide by the end of the first quarter.

Nebulized therapy allows patients to inhale the medication into their lungs. Once its safety and efficacy are confirmed through animal testing by the end of the first quarter, large- scale clinical trials with regulatory agencies would follow based on interim results.

The company expects the new cocktail therapy would be an economical and convenient treatment option for patients as at-home treatments increase.

Celltrion shares lost 2.02 percent to close at 194,500 won ($162.69) on Tuesday, while its marketing arm Celltrion Healthcare shares ended 1.37 percent lower at 79,100 won. Its drug development unit Celltrion Pharm stock fell 2.97 percent to 120,800 won.

By Jung Hee-young and Susan Lee

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