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Celltrion submits application for inhaled COVID-19 antibody treatment

A global phase 3 clinical study will evaluate the inhaled antibody cocktail treatment for patients with mild-to-moderate COVID-19 symptoms

COVID 19

Celltrion has announced that it has submitted an Investigational New Drug (IND) application for its inhaled COVID-19 antibody cocktail treatment and plans to begin a global phase 3 clinical trial to assess the treatment's safety and effectiveness.

The COVID-19 antibody cocktail is made up of regdanvimab and CT-P63, with the two monoclonal antibodies combined to target new strains of coronavirus, including the highly transmissible Omicron variant.

The company expects to enrol around 2,200 people with mild-to-moderate symptoms of COVID-19 in the trial.

The treatment uses an antibody platform which directly traps the virus in mucus found in the patient’s airway, thereby preventing localised infection. This helps to rapidly eliminate the virus from the lungs via the body’s natural ability to rid itself of mucus.

The benefits of the inhaled treatment means that it can be readily self-administered by patients, using a nebuliser, thus reducing the pressure on healthcare staff to assist with treatment and reducing clinic space usually needed for patients requiring intravenous drugs.

Dr HoUng Kim, head of medical and marketing division at Celltrion Healthcare, said: “We have accelerated development of our inhaled COVID-19 antibody cocktail therapy, leveraging our antibody platform to address the ongoing challenges of the pandemic”.

Dr Kim added: “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."

Article by
Fleur Jeffries

8th February 2022

From: Regulatory

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