Controversy is expected as Celltrion abandoned the clinical trial of the preventive effect of the antibody treatment for the novel coronavirus infection (Corona 19), “Recyrona (ingredient name Regdanvimab)”.
In addition to doubts about the effectiveness of Rekkirona’s prevention of Corona 19, Celltrion decided to withdraw from the government support project within a month, wasting administrative power due to premature support, and delaying the development of domestic treatments.
On October 8 last year, Celltrion was approved by the Ministry of Food and Drug Safety for a phase 3 prophylaxis clinical trial for the Corona 19 antibody treatment’Rekkirona (code name CT-P59)’. At the time, Celltrion announced that it would start preventive clinical trials in earnest upon approval.
Celltrion plans to confirm the effect of preventing infection and killing the virus in the early stages of about 1,000 people in close contact and asymptomatic in Korea.
Celltrion expects that when Rekirona is administered to patients at high risk of COVID-19, such as medical staff in close contact with patients and the elderly with weak immunity, it will be able to see the effect of preventing infection that cannot be sufficiently covered by the vaccine.
However, according to the “Abandonment of the 2020 2nd Selection Project Agreement for Corona 19 Treatment and Vaccine New Drug Development Project” submitted by the Ministry of Health and Welfare by Chun Bong-min (Health and Welfare Committee), Celltrion is currently offering Reckirona’s prophylactic antibody treatment. Gave up clinical trials.
According to this, Celltrion submitted a waiver to the government’s cross-ministerial drug development project team in mid-December of the same year, less than a month after’Development of Preventive Antibody Therapy’ was selected as the second selection task in November of last year.
Celltrion’s clarification on this also raises wonder. It was said that the reason for the withdrawal of clinical trials made it difficult to recruit clinical trial participants due to vaccine development and national blockade by global pharmaceutical companies.
According to the data submitted to the Ministry of Food and Drug Safety, the initially scheduled preventive effect clinical trials were Pocheon Hospital of Gyeonggi Medical Center, Paju Hospital of Gyeonggi Medical Center, Icheon Hospital of Gyeonggi Medical Center, Uijeongbu Hospital of Gyeonggi Medical Center, Anseong Hospital of Gyeonggi Medical Center, Suwon Hospital of Gyeonggi Medical Center, and Keimyung University. Daegu Dongsan Hospital, Bitgoeul Chonnam National University Hospital, Chungnam National University Hospital, Seoul Medical Center, Gil Hospital, etc.
It is pointed out that the difficulty in recruiting patients is only superficial, and in fact, it is because the economic feasibility of obtaining a preventive effect indication has declined in a situation where the vaccine supply is already in progress.
Some point out that domestic clinical patient recruitment and national blockade are irrelevant.
A former lawmaker informed of this fact, “The government has invested hundreds of billions of dollars to develop a domestic treatment for Corona 19, but the treatment for severely ill patients, which is urgently developed, has not been developed.” “The government may have additional Corona 19 In preparation for re-proliferation, a more systematic support plan should be prepared.”
The government provided a total of 31.7 billion won for the development of Celltrion’s antibody treatments in August and November last year.
Meanwhile, in response to the former lawmaker’s claim, Celltrion said, “We will focus more on the phase 3 clinical trial, which is the prerequisite for conditional approval,” and “We will continue to develop antibody treatments for responding to the COVID-19 mutant virus.”