Celltrion said that it has received approval from the Therapeutic Goods Administration (TGA) of Australia to conduct a phase 1 clinical trial plan for the inhalational formulation of Regkirona, a Covid-19 treatment.
Inhalon Biopharma, a U.S.-based bio-company that signed a contract with Celltrion to develop the inhaled-version of Regkirona, will administer the treatment to 24 healthy subjects in the first phase of the clinical trial, followed by a phase 2 clinical trial for efficacy evaluation within this year.
Celltrion and Inhalon started discussing the development of inhaled Regkirona in July last year and went through a period of preparation for about a year.
“The two companies focused on the fact that the size of the drug particle determines the delivery of an inhaled drug to the respiratory tract,” the Celltrion said. “After confirming that the inhaled Regkirona captures SARS-CoV-2 virus-like particles in the human airway mucus environment, the two companies decided to enter non-clinical trials.”
In January, Inhalon started non-clinical studies on rodents. After confirming the safety and tolerability of repeated administration of inhaled Regkirona, the company decided to proceed with phase 1 clinical trial in Australia, it added.
Celltrion expects that the inhaled Regkirona will further increase the accessibility of antibody therapeutics.
“Even if an oral treatment for Covid-19 is released, inhaled Regkirona will become another convenient option for patients who need antibody treatment,” it.
Celltrion also stressed that they would create a synergistic effect with the inhaled Regkirona in the future with its Covid-19 rapid diagnosis kit currently on the market.
“In a situation where Covid-19 variant cases are spreading rapidly, we are doing our best to speed up the development of inhaled-version of Regkirona and improve access to treatment for medical staff and patients by providing a new option for Covid-19 treatment,” a company official said. “To prevent the spread of Covid-19, we will continue to devise various measures at the company level to contribute to the end of the situation.”