Celltrion Halts European Clinical Trials of COVID-19 'Inhalation Therapy'

'CT-P63+CT-P66' Phase 3 Clinical Trial Halted
Business Feasibility Declined Due to Endemic Transition

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

[Asia Economy Reporter Lee Chun-hee] Celltrion has decided to halt the European clinical trials of its 'inhalable cocktail antibody treatment' developed to combat major COVID-19 variants including Omicron. The company judged that the business feasibility has declined as COVID-19 shifts from a pandemic to an endemic phase.

On the 28th, Celltrion announced that it decided to stop the Phase 3 European clinical trials of the inhalable COVID-19 treatment (CT-P63+CT-P66), which had been approved by the Romanian National Agency for Medicines and Medical Devices on the 27th of last month (local time).

Originally, Celltrion planned to demonstrate the efficacy and safety of CT-P63 and CT-P66 administered together as inhalants in a Phase 3 clinical trial involving 2,200 mild to moderate COVID-19 patients in Europe. CT-P63 is a cocktail antibody treatment candidate developed by Celltrion to respond to COVID-19 variants, and CT-P66 is the inhalable formulation of Regkirona.

Celltrion explained the reason for halting the trials as "a change in the COVID-19 treatment development strategy to respond to the rapidly changing global COVID-19 environment after the Omicron variant." While COVID-19 is becoming endemic, the size of Phase 3 clinical trial patient groups required by global regulatory agencies is larger than expected, making the business feasibility minimal. As the disease enters the endemic phase, regulatory agencies are gradually moving away from 'fast track' procedures such as emergency approvals, and global big pharma companies conducting trials on standard risk groups rather than high-risk groups tend to fail to prove efficacy due to weakened pathogenicity.

Celltrion plans to continue managing and researching its pool of cocktail antibody candidates for COVID-19 while closely monitoring the pandemic situation. Through this, the company aims to continue research and evaluation of COVID-19 antibody treatments capable of responding to a wide range of variants.

Additionally, Celltrion will continue platform research for the development of messenger RNA (mRNA) vaccines and oral COVID-19 treatments to prepare for potential future pandemics. To expand treatment accessibility in low- and middle-income countries, Celltrion is developing oral COVID-19 treatment products under generic licenses for Pfizer's Paxlovid and MSD (Merck & Co., USA)'s Molnupiravir, secured at the group level through the United Nations-backed Medicines Patent Pool (MPP). The company aims to supply these products early next year.

A Celltrion representative stated, “The clinical and approval environment for COVID-19 treatments is changing due to the spread of Omicron subvariants. As we approach the transition to endemicity, we will closely monitor international environmental changes, reorganize our COVID-19 treatment development direction, and devote ourselves to developing various pipelines currently in clinical trials and approval stages to contribute to the advancement of South Korea’s bioindustry.”

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