Celltrion's Covid treatment found effective in Phase 2 trial

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Celltrion's Covid treatment found effective in Phase 2 trial

Published: 13 Jan. 2021, 19:28 Updated: 13 Jan. 2021, 19:50

Celltrion’s CT-P59 was proven to speed up the recovery time for Covid-19 infection in a Phase 2 clinical trial. [YONHAP]

Celltrion’s Covid-19 treatment candidate has been proven to speed up the recovery time for the infected in a Phase 2 clinical trial, according to the drug maker speaking at an academic conference on Wednesday.

It would be the first coronavirus therapy developed in Korea.

Those who received CT-P59, or regdanvimab, had a median recovery time of 5.4 days compared with 8.8 days among those who received a placebo, cutting about 3 days off the recovery time.

The candidate drug also reduced the possibility of cases worsening to the severe level, which requires hospitalization, by 54 percent.

For those aged over 50 with moderate symptoms, the likelihood shrank by 68 percent.

The tests were conducted on 327 patients last year with mild to moderate symptoms in Korea, Romania, Spain and the United States. Doses of 40 milligrams were administered.

The result, released through an electronic disclosure site ahead of the conference, also stated that no adverse effects had been reported during the test.

“The data demonstrate that CT-P59 could contribute to both a reduced time to clinical recovery, as well as a reduced proportion of patients who progress to a severe condition.” said Professor Eom Joong-Sik, Infectious Disease Division at Gil Medical Center of Gachon University in a statement.

“The treatment’s safety profile was comparable to that of placebo and generally well-tolerated. Therefore, it is anticipated that CT-P59 will positively contribute to the management and control of the current Covid-19 pandemic around the world,” he said.

With the optimistic result, the Songdo-based drug maker will go on with the third phase of trials. It submitted an application to obtain the conditional use permit for its treatment candidate last month.

The unit has been authorized to start Phase 3 clinical trials in Korea, Romania, the United States, Britain, Spain and Italy.

The successful result was hinted at during a discussion at the National Assembly on Tuesday, where a senior official of Celltrion said that the candidate has been proven to show comparable or even better performance than competing drugs.

“We’ve confirmed that [the CT-P59] has shown either comparable or better efficacy than antibody treatments including those from Eli Lilly and Regeneron,” said Kwon Ki-sung, head of the research and development department of Celltrion, during the meeting.

“Empirical data has shown that the drug is effective in holding the virus at bay and keeping the patient from developing severe respiratory conditions. We’re hoping to get it approved by the Ministry of Food and Drug Safety within the month,” he said.

Kwon also added that the treatment candidate is more effective when taken in the early stage.

Whereas the Phase 2 tests focused on verifying the treatment candidate’s ability to reduce the recovery period, Phase 3 trials will observe whether it is effective in reducing the portion of patients whose conditions would have worsened and required hospital care or oxygen therapy.

Gilead Sciences’ remdesivir is the only Covid-19 treatment approved for use in Korea.

BY PARK EUN-JEE [park.eunjee@joongang.co.kr]