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Celltrion's COVID treatment has efficacy in Phase 2 trials

Celltrion's COVID-19 treatment Regkirona (CT-P59) / Courtesy of Celltrion
Celltrion's COVID-19 treatment Regkirona (CT-P59) / Courtesy of Celltrion

By Nam Hyun-woo

Celltrion said Wednesday that its Regkirona anti-COVID-19 drug, also known as CT-P59, has had its efficacy proven for the treatment of patients with mild to moderate symptoms of the coronavirus disease in global Phase 2 clinical trials. This bodes well for the company to win domestic approval for use of the treatment in Korea.

The biotech company filed for conditional approval for use with the Ministry of Food and Drug Safety, Dec. 29. Given the ministry has shortened its review process to a maximum 40 days and the trials have shown a favorable outcome, the treatment is expected to be marketed here as early as late this month.

According to Celltrion, Regkirona reduced the number of patients with mild to moderate COVID-19 symptoms from progressing to the severe stage requiring hospitalization by 54 percent compared to a placebo, during Phase 2 trials on 327 patients in Korea, Romania, Spain and the United States. Among those aged over 50, the rate was 68 percent.

Also, the time required for clinical recovery was 5.4 days for the Regkirona group, while that of placebo group was 8.8 days, meaning the drug shortened the recovery period. The company added that recovery was five to six days shorter for moderately ill patients.

The company said the group taking Regkirona showed a significantly lower level of virus concentration seven days after injection, while it required 10 days for the placebo group to reach the same level.

"During the trials, Regkirona proved that it can significantly reduce the rate of patients progressing from the mild to severe stage, as well as helping patients recover quickly," said prof. Uhm Joong-sik of Gacheon University Gil Medical Center who led the Phase 2 trials. "We believe not only vaccines but also treatments are essential to contain the pandemic."

Celltrion said it has already produced 100,000 doses to supply the treatment as soon as the ministry gives it conditional approval.

Conditional approval is given to a new drug that has gone through a Phase 2 clinical trial successfully, if there is no other treatment for the disease. The drug developer is required to continue with and finish full clinical trials at the same time. Celltrion will launch Phase 3 studies in more than 10 countries.

Based on the Phase 2 trial data, the company said it will apply for similar approval from the health authorities in the U.S. and Europe, adding it is planning to manufacture up to 2 million doses to meet global demand.

When exported, Regkirona's cost is anticipated to be below 4 million won ($3,650), cheaper than that of other COVID-19 treatments from Eli Lilly or Regeneron.

So far, Remdesivir by Gilead Sciences is the only drug approved as a COVID-19 treatment in Korea. Should Regkirona win conditional approval, it will be the first Korean COVID-19 treatment.

The results of the Phase 2 trials will also be announced by Michael Ison of Northwestern Medicine at the Keystone Symphosia in the U.S., Wednesday (local time).

A Celltrion researcher tests a drug substance in this undated file photo. Courtesy of Celltrion
A Celltrion researcher tests a drug substance in this undated file photo. Courtesy of Celltrion
Celltrion's COVID-19 treatment Regkirona (CT-P59) / Courtesy of Celltrion
Celltrion's COVID-19 treatment Regkirona (CT-P59) / Courtesy of Celltrion

By Nam Hyun-woo

Celltrion said Wednesday that its Regkirona anti-COVID-19 drug, also known as CT-P59, has had its efficacy proven for the treatment of patients with mild to moderate symptoms of the coronavirus disease in global Phase 2 clinical trials. This bodes well for the company to win domestic approval for use of the treatment in Korea.

The biotech company filed for conditional approval for use with the Ministry of Food and Drug Safety, Dec. 29. Given the ministry has shortened its review process to a maximum 40 days and the trials have shown a favorable outcome, the treatment is expected to be marketed here as early as late this month.

According to Celltrion, Regkirona reduced the number of patients with mild to moderate COVID-19 symptoms from progressing to the severe stage requiring hospitalization by 54 percent compared to a placebo, during Phase 2 trials on 327 patients in Korea, Romania, Spain and the United States. Among those aged over 50, the rate was 68 percent.

Also, the time required for clinical recovery was 5.4 days for the Regkirona group, while that of placebo group was 8.8 days, meaning the drug shortened the recovery period. The company added that recovery was five to six days shorter for moderately ill patients.

The company said the group taking Regkirona showed a significantly lower level of virus concentration seven days after injection, while it required 10 days for the placebo group to reach the same level.

"During the trials, Regkirona proved that it can significantly reduce the rate of patients progressing from the mild to severe stage, as well as helping patients recover quickly," said prof. Uhm Joong-sik of Gacheon University Gil Medical Center who led the Phase 2 trials. "We believe not only vaccines but also treatments are essential to contain the pandemic."

Celltrion said it has already produced 100,000 doses to supply the treatment as soon as the ministry gives it conditional approval.

Conditional approval is given to a new drug that has gone through a Phase 2 clinical trial successfully, if there is no other treatment for the disease. The drug developer is required to continue with and finish full clinical trials at the same time. Celltrion will launch Phase 3 studies in more than 10 countries.

Based on the Phase 2 trial data, the company said it will apply for similar approval from the health authorities in the U.S. and Europe, adding it is planning to manufacture up to 2 million doses to meet global demand.

When exported, Regkirona's cost is anticipated to be below 4 million won ($3,650), cheaper than that of other COVID-19 treatments from Eli Lilly or Regeneron.

So far, Remdesivir by Gilead Sciences is the only drug approved as a COVID-19 treatment in Korea. Should Regkirona win conditional approval, it will be the first Korean COVID-19 treatment.

The results of the Phase 2 trials will also be announced by Michael Ison of Northwestern Medicine at the Keystone Symphosia in the U.S., Wednesday (local time).

A Celltrion researcher tests a drug substance in this undated file photo. Courtesy of Celltrion
A Celltrion researcher tests a drug substance in this undated file photo. Courtesy of Celltrion
Nam Hyun-woo namhw@koreatimes.co.kr

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