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[Newsmaker] Celltrion confirms phase 1 trial safety of COVID-19 antibody drug

Global clinical phase 2, 3 trials to take place in as many as 12 nations

By Lim Jeong-yeo

Published : Sept. 11, 2020 - 14:36

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Celltrion said Friday that it had confirmed the safety of COVID-19 antibody drug CT-P59 in healthy people through a domestic phase 1 trial involving 32 people.

Once another clinical phase 1 trial targeting light-symptom COVID-19 patients wraps up, Celltrion plans to proceed to global phase 2 and 3 trials in as many as 12 nations targeting 500 patients.

Clinical test designs for these global trials have already been submitted in seven countries, Celltrion said.

Although the company refrained from sharing where these countries are, a Celltrion official said that by testing CT-P59 in diverse territories, the drug may prove its efficacy in fighting various mutations of SARS CoV-2 virus.

The company aims to gather midterm trial results from global trials by end-2020 and finish development of CT-P59 within the first half of 2021, Celltrion said.

CT-P59 is entering mass production this month, according to Celltion, to preemptively meet the demands upon development completion.

“We aspire to deliver the drug as quickly as possible through an emergency usage application by yearend,” said a Celltrion official.

CT-P59 is being developed jointly by Celltrion and Korea Centers for Disease Control and Prevention.

In Korea, Celltrion had two clinical phase 1 trials undergoing; one that has wrapped up Friday had tested the drug on 32 healthy candidates to see the drug’s toxicity and absorption rate in the human body.

In maximum dosages per cohort, CT-P59 triggered no abnormalities in patient reactions, Celltrion announced.

By Lim Jeong-yeo (kaylalim@heraldcorp.com)