Celltrion Group’s honorary chairman Seo Jeong-jin directly refuted the concerns and suspicions related to the clinical results of the new coronavirus infection (Corona 19) antibody treatment “Recyronaju” (ingredient name Regdanvimab CT-P59), which was conditionally licensed.
We are confident that we will be able to respond to any COVID-19 mutations in the future if we use the antibody platform we have while explaining the clinical results of Rekirona.
Honorary Chairman Seo, at an online press conference on the 18th, revealed the results of Phase 2 clinical trials for mild and moderate symptoms of Rekkirona and explained future plans.
Rekironaju has been supplied to medical institutions nationwide from the previous day. Celltrion is supplying the drug at manufacturing cost, and there is no cost to the patient.
On the day, Celltrion clarified about the fact that Rekirona was not able to secure some statistical significance in clinical practice, was not effective in mild patients, and concerns that antibody therapy could be rather’toxic’ to severe patients.
“Since the number of patients (327 patients) who participated in the phase 2 clinical trial is small, there may be questions about the statistical significance,” said Kim Seong-hyun, chief of clinical planning for Celltrion. It is for” he emphasized.
It is for a series of points that statistical significance was not secured in some clinical indicators.
He emphasized that the effect on mild patients was also confirmed.
He said, “Even in mild patients, the time it takes for clinical recovery has been shortened by more than 2 days.” It’s different from” he said.
Honorary Chairman Seo also said, “There are a lot of stories about statistical significance. How can all of the effects of reducing the virus and shortening the recovery period appearing in about 300 people?” said, “How can drugs for pneumonia be ineffective in mild patients? Can you do it?”
Regarding the controversy that the time when the corona 19 virus transitions from positive to negative (negative time) is not clinically significant, the honorary chairman Seo said, “I have never been asked such a question in other countries.” Agreed that it could not be a major endpoint,” he emphasized.
It also actively clarified concerns that antibody treatments may cause an ADE (antibody-dependent enhancement) reaction in severely ill patients and become’toxic’.
ADE means that a person who has been given an antibody or vaccine against the virus will be infected with a mutant virus in the future, and the symptoms will be much worse.
“The ADE phenomenon in which the viral symptoms are intensified or the amount of virus increases due to the antibody is only possible when specific conditions are met,” said Kim, chief of clinical planning. “After developing a neutralizing antibody, we found ADE side effects. I have never,” he dismissed.
Honorary Chairman Seo also criticized, “The ADE has not been reported from corona19 patients,” and criticized “Isn’t it too irresponsible to express this as’poison’ rather than medicine?”
Earlier, Celltrion Rekironaju received product approval from the Ministry of Food and Drug Safety, subject to submission of the results of phase 3 clinical trials by the end of this year. Honorary Chairman Seo predicted, “Beginning from phase 3 a month ago, 150 patients have now received antibody therapy,” and “It will take 5 months for data to be released after 3 months after the administration is complete.”
Honorary Chairman Seo also explained, “We are currently in the preliminary screening stage of the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).”
On this day, Celltrion also emphasized that it was fully prepared to respond to the COVID-19 mutation. Celltrion has already announced on the 11th that it has begun developing a’mutation-tailored treatment’ and announced that it will complete the clinical trial within 6 months.
Currently, Celltrion has 38 neutralizing antibodies, of which candidate antibody No. 32 showed neutralizing ability to neutralize mutant viruses in Britain and South Africa.
Accordingly, Celltrion is developing a new’mutation-tailored cocktail treatment’ that utilizes candidate antibody No. 32 while supplying Rekirona as a mainstay.
“We have already secured a variety of neutralizing antibody pools, so we can cope with any mutations,” said Kwon Ki-seong, head of Celltrion’s research and development division.
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