Celltrion to file for emergency approval of COVID-19 cure within the year

2020.09.17 10:18:06 | 2020.09.17 17:27:12

[Photo by Han Joo-hyung]이미지 확대

[Photo by Han Joo-hyung]

South Korea’s bio firm Celltrion expects to enter Phase 2/3 trials of its experimental antibody cure for COVID-19, CT-P59, at home and Europe this month and file for emergency authorization or approval based on potential positive results by the end of this year.

The company’s chairman Seo Jung-jin on Wednesday released the roadmap for the cure at the 21st World Knowledge Forum in Seoul, with the application for a Phase 2 Investigational New Drug (IND) trial of CT-P59 already submitted in five countries including Korea/

IND filings will continue in five other countries this week, he said, declaring the ongoing global pandemic will only end when the world finally has a perfect treatment or a perfect vaccine - possibly by the second half of next year.

Celltrion shares ended Thursday at 291,500 won ($248.61), down 1.85 percent from the previous session, and its marketing arm Celltrion Healthcare 1.6 percent lower at 98,100 won.

If the Phase 2 trial is completed by the end of this year and Phase 3 by March and April next year, Korea will be able to get solutions that can range from diagnosis to treatment by the end of next year, he said.

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However, treatments and vaccines may take more time to develop because of virus mutations or the appearance of different virus types. Seo said. The potential variables could delay its target schedule by more than one year, he added.

Seo explained COVID mutations have occurred in the direction that its docking point for body penetration becomes hard, but no different type has been found.

The company’s planned global Phase 2 and 3 trials will be conducted simultaneously, which will involve more than 1,000 patients. Seo said the company will also conduct trials to evaluate whether the antibody cure can prevent coronavirus infection in some 1,000 people.

Celltrion completed a Phase 1 clinical trial of CT-P59 in 32 healthy volunteers in July. Antibody treatments have the advantage of higher safety and fewer side effects than other treatments such as plasma therapy, but the development period is rather longer.

Celltrion recently started production of the COVID-19 treatment at its 12,500-liter capacity site with initial 12 batches for trial and commercial use, which can cover nearly 90,000 patients at once.

By Chung Seul-gi and Minu Kim

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