Celltrion Completes Patient Recruitment and Dosing for Global Phase 2 Clinical Trial of COVID-19 Antibody Treatment

Conditional Approval Application Plan... Global Phase 3 Clinical Trial Scheduled to Begin

[Asia Economy Reporter Seo So-jung] As of 4 a.m. on the 25th, Celltrion has completed dosing for 327 patients enrolled in the global Phase 2 clinical trial of the COVID-19 antibody treatment 'CT-P59 (generic name Regdanvimab)'.

Celltrion plans to apply for conditional approval after confirming the interim results of Phase 2. Having received approval from the Ministry of Food and Drug Safety on September 17 for the Phase 2 and 3 clinical trials of CT-P59, Celltrion has been conducting Phase 2 trials in major domestic medical institutions as well as in countries including the United States, Romania, and Spain.

In Phase 2, the efficacy and safety of CT-P59 are being primarily evaluated in patients with mild to moderate COVID-19 symptoms. Celltrion secured 327 subjects, exceeding the initially planned 300 patients for Phase 2. Typically, about 10% additional recruitment is made to ensure stable clinical trials.

Celltrion classified the Phase 2 subjects into placebo, low-dose, and high-dose groups for dosing and plans to verify CT-P59’s efficacy, safety, and optimal dosage through data analysis.

Additionally, Celltrion aims to promptly derive interim results from Phase 2, closely consult with relevant agencies such as the Ministry of Food and Drug Safety, and apply for conditional approval of CT-P59. If conditional approval is granted, Celltrion has already started production at its Incheon Songdo facility since September to supply CT-P59 sufficient to treat approximately 100,000 domestic COVID-19 patients, completing initial production volumes for immediate therapeutic use.

The global Phase 3 trial will commence soon. The Phase 3 trial is planned to be conducted in over 10 countries worldwide, aiming to further verify the efficacy and safety of CT-P59 in a broader patient population based on Phase 2 findings. Furthermore, Celltrion will accelerate the final product approval process by following clinical procedures that comply with global regulatory agencies’ new drug approval standards.

Currently, plans are underway to produce enough treatment doses annually to supply 1.5 to 2 million patients for overseas mass distribution.

A Celltrion official stated, "With the smooth progress of CT-P59’s Phase 2 and 3 trials, we will do our best to quickly produce meaningful results and complete the development of the treatment so that the public can return to their daily lives as soon as possible."