Baek Byung-yeul is a journalist at The Korea Times focused on cultural content, including films and cultural events in South Korea. You can contact him at baekby@koreatimes.co.kr to share your insights.
BIO WEBINAR 'Celltrion will complete Phase 3 trial of COVID treatment within H1 2021'
Lee Soo-young, vice president at Celltrion, speaks during The Korea Times' Bio Webinar, March 26. Captured during the event
By Baek Byung-yeul
By Baek Byung-yeul
Logo for Celltrion
Celltrion aims to complete the Phase 3 clinical trial of its Regkirona anti-COVID-19 drug, also known as CT-P59, within the first half of 2021, Lee Soo-young, vice president of Celltrion, said during The Korea Times' Bio Webinar, March 26.
“We are currently conducting Phase 3 clinical trials of the Regkirona against 1,172 patients with mid-to-moderate symptoms of COVID-19 in some 10 countries including the United States, Spain, South Africa and Hungary,” he said. “We are aiming to complete the Phase 3 clinical trials of the Regkirona within the first half of this year and will go through formal approval procedures.”
The inaugural event featured executives from four major biotech companies here including Celltrion, Samsung Biologics, LG Chem and SK Bioscience as well as the director general from the Ministry of Trade, Industry and Energy. They discussed what needs to be improved to enhance the country's competence in the biotech industry.
Celltrion could swiftly come up with the antibody COVID-19 treatment based on the company's experience in developing a potential treatment for Middle East Respiratory Syndrome (MERS) in 2015 as well as the government's support.
Shortly after the outbreak of the coronavirus pandemic, Celltrion quickly announced it would launch an anti-COVID-19 drug development process in February 2020. In cooperating with the government, the company could significantly reduce the Phase 2 clinical trial period to 10 months, and filed for conditional approval for use with the drug safety ministry on Dec. 29.
On Feb. 5, Celltrion received a conditional use approval with its Regkirona treatment from the Ministry of Food and Drug Safety on the condition that the company submits results of the global Phase 3 clinical trial.
According to the Korea Disease Control and Prevention Agency's March 18 data, 541 patients in 47 hospitals received the Regkirona treatment. Doctors who administered the treatment showed positive reaction saying coronavirus patients could see their lung condition improved, Lee said.
“The efficacy of the Regkirona treatment was confirmed from our Phase 2 clinical trials as the rate of progressing patients with mild-to-moderate symptoms decreased by 54 percent and 68 percent of moderate patients aged 50 years and over. Also, the Regkirona-treated group had a shorter recovery time compared to the placebo group,” the vice president said.
Lee said Celltrion is also promptly responding to new coronavirus variants, which are spreading rapidly in many countries such as South Africa, the U.K. and Brazil, by developing a neutralizing antibody cocktail.
“We've found that our Regkirona successfully neutralized the U.K. variant, but its efficacy was reduced in treating the South African variant. To combat the South African variant, the company is developing an antibody cocktail treatment that combines the CT-P59 with the 32nd antibody among our antibody candidates for COVID-19 variants,” Lee said.
Regarding the production capacity of its COVID-19 treatment, the vice president said the company produced 300,000 vials for 100,000 people in 2020 and will be able to produce at least 3.9 million vials for 1.3 million people this year..
“If we operate our production facilities at full capacity, we can produce vials of Regkirona for up to 3.2 million people annually,” the vice president said.
Speaking of what needs to be improved for the country's biotech industry, Lee called on the government to provide financial and operational support to domestic companies so that they can conveniently implement clinical trials and other new drug development processes.
“When developing the Regkirona drug, there were not many differences between Korea and other biopharma powerhouses in terms of guidelines for clinical trials. However, the government needs to offer more support measures such as attracting prominent overseas contract research organizations to help local firms develop new drugs,” Lee said.