With the mix of mutations in omicron raising fears the new COVID-19 virus will evade our existing defenses, Celltrion is stepping up work on a nebulized cocktail it thinks may remain effective against the pathogen.
The proposed candidate brings together Regkirona, which recently won approval in Europe, and the investigational CT-P63. Having partnered with Inhalon Biopharma in July, Celltrion now has data on a nebulized formulation of Regkirona, called IN-006, that could enable self-administration, trap the virus in airway mucus and get the antibody quickly to the key battleground of the lungs.
However, omicron could nullify those potential benefits of nebulized delivery by blunting the power of Regkirona. As such, Celltrion plans to combine nebulized Regkirona with the earlier-stage CT-P63.
Celltrion began a phase 1 clinical trial to study the safety, tolerability and pharmacokinetics of CT-P63 in healthy subjects in September. The study has now enrolled its 24 subjects. That puts Celltrion on course to deliver data by the end of the year, but, with omicron threatening to significantly reduce the efficacy of existing monoclonal antibodies, the company has already decided to step up activity.
The commitment to accelerate development of a nebulized formulation of Regkirona and CT-P63, starting with a follow-up trial to show its effect on new variants, reflects a belief the later candidate can neutralize omicron.
“Omicron has many mutations in the same regions of the spike protein, however we anticipate CT-P63 to maintain strong neutralizing ability against omicron based on structural analysis by X-ray crystallography and neutralization data from pseudo-virus testing,” HoUng Kim, Ph.D., head of the medical and marketing division at Celltrion Healthcare, said in a statement.
Celltrion’s nebulized formulation is based on a muco-trapping platform. The idea is to trap the virus in airway mucus, thereby stopping it from spreading and enabling the treatment to quickly eliminate the threat.