Celltrion's Inhaled COVID-19 Treatment 'Rekkirona' Enters Phase 1 Clinical Trial in Australia

Incheon Songdo Celltrion Plant 2 Overview. / Incheon - Photo by Hyunmin Kim kimhyun81@

[Asia Economy Reporter Seo So-jeong] Celltrion announced on the 10th that it received approval for the Phase 1 clinical trial application (IND) for the inhalation formulation of the COVID-19 treatment 'Rekkirona' from the Australian TGA (Therapeutic Goods Administration) on the 4th (local time) and will accelerate its development.

The U.S. biotech company Inhalon Biopharma, which has signed a contract with Celltrion and is developing the inhalation form of Rekkirona, will conduct administration on 24 healthy subjects in this Phase 1 trial and plans to evaluate efficacy in Phase 2 within this year.

Celltrion and Inhalon began discussions on the development of inhalation Rekkirona in July last year and underwent about a year of preliminary preparation. Subsequently, the two companies focused their research on the fact that the delivery of inhaled drugs to the respiratory tract is determined by the size of the drug particles, and confirmed in October last year that the aerosol particle size of Rekkirona generated through the inhaler is suitable for delivery to the respiratory tract.

After confirming that inhaled Rekkirona captures SARS-CoV-2 virus-like particles in the human airway mucus environment, they proceeded to non-clinical trials. In January this year, non-clinical trials were initiated on rodents (rats) to verify the safety and tolerability of repeated administration of inhaled Rekkirona, leading to the current Phase 1 clinical trial in Australia.

Celltrion expects that inhaled Rekkirona, which delivers antibodies to the airway mucosa infected with the COVID-19 virus, will enhance accessibility to antibody therapeutics by directly delivering the drug to the lungs via the respiratory tract, thereby improving patient convenience.

A Celltrion official stated, "We will accelerate the development of inhaled Rekkirona to improve treatment accessibility for medical staff and patients and do our best to provide a new option for COVID-19 treatment."

This content was produced with the assistance of AI translation services.