Speeding up COVID-19 Antibody Treatment Development... MFDS Simultaneously Approves Celltrion Phase 2 and 3 Trials

Phase 1 Clinical Trial of Neutralizing Antibody Treatment Completed, Phase 2 and 3 Approved
"Tolerability Confirmed in Phase 1... 300 Participants in Phase 2, 720 in Phase 3"

Clinical material of the COVID-19 antibody treatment developed by Celltrion

[Asia Economy Reporter Choi Dae-yeol] The Ministry of Food and Drug Safety announced on the 17th that it has approved the Phase 2/3 clinical trial of the novel coronavirus disease (COVID-19) neutralizing antibody treatment (CT-P59) developed by Celltrion.

Neutralizing antibodies are antibodies that can neutralize the COVID-19 virus. This is a follow-up clinical trial to the Phase 1 clinical trial approved and conducted earlier in July and August. In the upcoming clinical trials, the efficacy and safety will be evaluated in patients with mild to moderate COVID-19.

The Ministry of Food and Drug Safety stated that in the Phase 1 clinical trial, tolerability was confirmed, meaning that the clinical trial subjects could endure side effects or discomfort when the drug was administered, making the next phase of clinical trials possible. By approving Phase 2, which involves administering the drug to patients to find therapeutic effects, and Phase 3, which involves administering the drug to a larger number of patients to assess safety and therapeutic effects, simultaneously, it is expected that the speed of clinical trials can be increased.

According to the Ministry, in Phase 2 clinical trials, 300 subjects will be targeted to explore the appropriate dosage and therapeutic effects for COVID-19 treatment, while in Phase 3 clinical trials, based on the confirmed dosage, efficacy and safety will be verified continuously with 720 subjects.

CT-P59 is a gene-recombinant neutralizing antibody treatment developed as a new drug by Celltrion. The principle is that the antibody treatment attaches to the site on the virus surface that binds to human cells, thereby preventing infection. Clinical trial plans have been submitted or are being prepared simultaneously in five countries including South Korea, the United States, and Romania. Overseas pharmaceutical companies such as Lilly are also conducting clinical trials of neutralizing antibody treatments.

With the approval of this clinical trial, a total of 19 clinical trials related to COVID-19 are currently underway in South Korea, including 17 for treatments and 2 for vaccines. The government and companies expect that antibody treatments will be available on the market by the first half of next year.

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