Celltrion Group announced that it has submitted an IND application for a Phase 3 trial of an inhaled COVID-19 antibody cocktail for the treatment of mild-to-moderate COVID-19. In July 2021, Celltrion announced that it had partnered with Inhalon Biopharma on development of an inhaled formulation of regdanvimab for the treatment of COVID-19. The proposed Phase 3 trial, which is expected to enroll 2,200 subjects, would evaluate an inhaled cocktail of CT-P59 regdanvimab and CT-P63.
According to Celltrion, a Phase 1 trial of inhaled CT-P59 conducted by Inhalon last year demonstrated that the formulation was safe and well tolerated. The company says that “The [Inhalon] 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.”
Celltrion Healthcare Head of Medical and Marketing HoUng Kim commented, “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 enrollment and global clinical trials in the coming months.”
Read the Celltrion press release.
