Celltrion Demonstrates Safety of 'Inhalable Antibody Therapy' in Phase 1 Clinical Trial... Global Clinical Trials Begin

Successful Completion of Phase 1 Clinical Trial Led by US Inhalon in Australia
Clinical Trial Plans Submitted for 3 Eastern European Countries
Effectiveness and Safety Proven in 2,200 Participants
CT-P63 Confirms Strong Neutralizing Ability Including Omicron Variant

[Asia Economy Reporter Lee Gwan-joo] Celltrion announced on the 7th that it has confirmed the safety of its COVID-19 inhalable antibody treatment in the Phase 1 clinical trial in Australia and has officially launched global clinical trials.

Inhalon Biopharma, a U.S. biotech company contracted by Celltrion to develop the inhalable antibody treatment, received approval for an Investigational New Drug (IND) application from the Australian Therapeutic Goods Administration (TGA) in August last year to conduct clinical trials on 24 healthy subjects. The Phase 1 trial was completed with all planned doses administered. Inhalon demonstrated safety as no serious adverse events or treatment discontinuations related to the drug occurred in the inhalable antibody treatment group during the trial.

With the safety of the inhalable antibody treatment confirmed, Celltrion is accelerating the development of an inhalable cocktail antibody treatment by adding 'CT-P63,' a COVID-19 therapeutic candidate confirmed safe in the early Phase 1 trial earlier this year. On the 3rd, Celltrion completed the submission of the Phase 3 clinical trial application for the inhalable cocktail antibody treatment in three Eastern European countries: Bosnia, Serbia, and North Macedonia. The company plans to expand the number of countries and conduct clinical trials on a total of 2,200 mild to moderate COVID-19 patients to verify the efficacy and safety of the inhalable cocktail antibody treatment.

Celltrion is closely consulting with countries where active cooperation with local government agencies and medical staff was achieved during the development of the intravenous antibody treatment (Rekkirona, CT-P59) for this global clinical trial. Considering the clinical trial environment, including the spread of virus variants, the company plans to expand clinical trials to countries where patient recruitment and trial progress are expected to proceed smoothly.

Celltrion and Inhalon signed a Confidential Disclosure Agreement (CDA) and Material Transfer Agreement (MTA) in August 2020 and have been developing the inhalable antibody treatment for one year and five months. The inhalable antibody treatment is expected to establish itself as an optimized platform for responding to variant viruses by co-administering CT-P63, which shows neutralizing ability against various variants.

In particular, the inhalable antibody treatment can rapidly neutralize the virus through a 'trapping (muco-trapping)' mechanism that captures the virus from the lungs and respiratory mucosa, the entry points of the virus. Since it delivers antibodies locally and directly to the lungs, it is expected to be more economical by achieving the same effect with a smaller amount of antibodies compared to intravenous administration.

In terms of efficacy and safety, it is expected to show a level equivalent to the existing intravenous treatment, whose results have been confirmed through accumulated prescription data. Since patients can self-administer the inhalation, this treatment method may become a viable option for home treatment if the COVID-19 virus becomes endemic in the future.

From the early stages of COVID-19 therapeutic development, Celltrion secured a potential cocktail candidate antibody pool consisting of 38 neutralizing antibodies. CT-P63 has already demonstrated strong neutralizing ability against major variants such as Alpha, Beta, Gamma, and Delta during development, and confirmed strong neutralization in in-house tests against the Omicron variant. Celltrion plans to establish a comprehensive variant response treatment solution by utilizing the inhalable treatment platform with enhanced responsiveness to the rapidly spreading Omicron variant domestically and internationally, as well as potential future variants.

A Celltrion official said, “The inhalable antibody treatment confirmed safety in Phase 1 and has entered global clinical trials for the cocktail inhalable treatment including CT-P63, accelerating the development of a COVID-19 treatment with improved convenience and variant responsiveness. We will do our best in patient recruitment and global clinical trials to ensure smooth progress in developing the inhalable cocktail antibody treatment and aim to secure interim results in the shortest possible time.”

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