Celltrion said Monday it has confirmed the safety of its inhaled Covid-19 antibody treatment through an Australian phase 1 clinical trial and plans to start global clinical trials for a cocktail version of the inhaled treatment.
Inhalon Biopharma, Celltrion's global partner, proved the inhaled antibody treatment group’s safety as there were no serious adverse events or discontinuation of medication due to adverse events.
Inhalon received an investigational new drug (IND) approval from the Australian Therapeutic Goods Administration to conduct a phase 1 clinical trial in 24 healthy subjects last August and completed dosing.
As the Inhalon has confirmed the safety of the inhaled antibody treatment, Celltrion plans to accelerate the development of an inhaled cocktail antibody treatment that adds CT-P63, a candidate for treating Covid-19, which the company confirmed to be safe in a clinical trial early this year.
Celltrion completed the submission of phase 3 clinical trial plans for the inhaled cocktail antibody therapy in three countries --Bosnia, Serbia, and North Macedonia – and plans to expand the number of countries to recruit 2,200 mild and moderate Covid-19 patients to prove the efficacy and safety of the inhaled therapy.
Celltrion plans to expand clinical trials in countries where patient recruitment and clinical progress proceed smoothly, considering the clinical trial environment, such as the spread of virus mutations.
The company expects the inhaled antibody therapy to become an optimized platform for responding to variants by co-administering CT-P63, which has neutralizing ability against such variants.
The inhaled antibody therapy can rapidly neutralize the virus through the muco-trapping mechanism that captures the virus from the lung or respiratory mucosa through which the virus penetrates.
"We plan to prepare a comprehensive mutation response treatment solution by using an inhaled treatment platform that has enhanced responsiveness not only to the Omicron variant, which is currently rapidly spreading at home and abroad but also to mutations that may occur in the future," the company said.
Celltrion expects the drug to show an equivalent level compared to the existing intravenous treatment.
Celltrion has secured a pool of potential cocktail candidates consisting of 38 neutralizing antibodies, considering that it is important to respond to variants from the beginning of the development of a treatment for Covid-19. CT-P63 already showed strong neutralizing ability in major mutations such as Alpha, Beta, Gamma, and Delta during the development process.
"The company has confirmed the safety of the inhaled antibody treatment in phase 1 clinical trials and is accelerating the development of a Covid-19 treatment with increased convenience and mutation response by entering the global clinical trial of a cocktail inhaled treatment by adding CT-P63," a company official said.
Celltrion will do its best to recruit patients and conduct global clinical trials to advance the development of an inhaled cocktail antibody treatment without any setbacks, the official added.