Celltrion Group has reportedly filed an IND (Investigational New Drug) application to perform a global Phase III clinical trial.

The trial will assess the safety and efficacy of an inhaled antibody cocktail therapy for COVID-19 patients with mild-to-medium symptoms. The trial is predicted to enroll nearly 2,220 patients across the world.

The inhaled antibody cocktail combines monoclonal antibodies and CT-P59 (regdanvimab), and CT-P63. It has been developed to tackle newly emerging SARS-CoV-2 mutations, including B.1.1.529 (the Omicron variant).

The global Phase III clinical trial mentioned in the IND application is designed to assess the efficacy and safety profile of the inhaled antibody cocktail.

The inhaled antibody cocktail for COVID-19 uses the muco-trapping antibody platform to directly trap the virus in airway mucus. This rapidly removes the virus from the lungs through the natural ability of the body to clear mucus thereby preventing the local spread of the infection.

HoUng Kim, Ph.D., the Head of Medical and Marketing Division at Celltrion Healthcare, has expressed that the organization has expedited the development of its inhaled antibody cocktail therapy for COVID-19.

Dr. Kim added that the delivery of the antibody through inhalation significantly reduces the amount of dose needed to attain a therapeutic effect in comparison to intravenous injections thus curbing the treatment cost.

An inhalable treatment can be administered by the patient in at-home settings and at a scale that cannot be attained using traditional inpatient intravenous infusion treatments.

It is worth noting that Inhalon Biopharma and Celltrion inked a confidential disclosure and material transfer agreement for the R&D of a regdanvimab formulation for inhaled administration in August 2020.

In addition, the companies obtained approval from Australia’s TGA (Therapeutic Goods Administration) to perform a Phase I trial on 24 healthy individuals. The study showcase that the inhaled formulation of CT-P59 attained an endpoint of tolerability and safety and there were no reports of serious adverse effects pertaining to the treatment.

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