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| On the afternoon of the 22nd,’CT-P59′, an antibody treatment for a novel coronavirus infection (Corona 19), which is undergoing clinical trials, is placed at Celltrion Plant 2 in Yeonsu-gu, Incheon. 2020.12.22/News1 © News1 Reporter Jeong Jin-wook |
Celltrion’s new coronavirus infection (Corona 19) antibody treatment’Recyrona’ is accelerating domestic commercialization. In particular, as the results of phase 2 clinical trials are announced at a domestic conference held this week, it is expected that the possibility of future treatment will be glimpsed.
Conditional permit screening is also in progress as scheduled. The Ministry of Food and Drug Safety conducts a survey on medical institutions that have conducted clinical trials this week, and will hold an advisory meeting to verify safety and effectiveness from early next week.
According to the Ministry of Food and Drug Safety and the industry on the 12th, the results of Global Phase 2 clinical trials of Celltrion Rekkirona will be announced at 6pm on the 13th at the High1 New Drug Development Symposium hosted by the Korean Pharmacy Society by Joongsik Um, a professor of infectious medicine at Gachon University Gil Hospital.
The theme of the presentation is’Therapeutic Effect of Regdanvimab (CT-P59) in Patients with Mild to Moderate Symptoms of SARS-CoV-2 infection: Day 28 Results from a Multicentre, Randomized Controlled Pivotal Trial).
This is based on the results of Phase 2 clinical trials of Rekirona, currently under review by the Ministry of Food and Drug Safety. Celltrion evaluated the safety and effectiveness of Rekirona administration in 327 patients with mild to moderate Corona19 in phase 2 clinical trials.
The main evaluation objectives are how long it takes for the virus to decrease after administration, and how long it takes for the drug to circulate in the body, as in general phase 2 clinical trials. The clinical researchers took samples of people who had been taking Rekirona, measured the time to turn negative in the virus test, and compared them with those who did not take the drug.
The key to the evaluation is how quickly patients receiving this drug recovered from the seven symptoms related to Corona 19, including fever, cough, and shortness of breath. If there is no significant difference in the time it takes to recover compared to a patient who has not taken the drug, the effectiveness will inevitably be questioned.
Another notable point is the possibility of domestic conditional approval approval. Currently, Rekkirona is undergoing a drug approval review system that seeks to use phase 3 clinically conditionally while completing phase 2 clinical trials.
In order to confirm rapid approval, Celltrion and the Ministry of Food and Drug Safety previously requested that, unlike general phase 2 clinical trials, when designing a phase 2 clinical trial, an index that can evaluate the effect such as improvement of clinical symptoms was added. In addition, the proportion of patients who need hospitalization and oxygen therapy, which are usually confirmed during phase 3 clinical trials, are also added.
Above all, achieving the symptom improvement effect is the most important evaluation goal, but if the index of lowering the proportion of patients who need oxygen therapy separately is met, conditional approval can be easily determined as a guarantee for the safety and effectiveness of phase 2 or more.
Sang-Bong Kim, head of the Bio-Pharmaceutical Bureau of the Ministry of Food and Drug Safety, said, “(Rekirona) Phase 2 clinical trials are similar in form and purpose to Phase 3,” and said, “If the treatment effect is confirmed in the phase 2 review results, the item is subject to submission of the results of the phase 3 clinical trial. You can consider permitting,” he said.
Examination procedures other than clinical data are also in progress. The treatment approval/examination process is in the order of’reception of approval application → preliminary review → examination and fact-finding → consultation → approval’.In the case of Corona 19 treatment and vaccine, the authorities decided to proceed with a rapid review within 40 days.
Accordingly, last week, the Ministry of Food and Drug Safety conducted an on-site survey of facilities and management systems at two factories where Celltrion’s antibody treatments were produced. The risk of microbial contamination in the manufacturing process was evaluated, and management of various facilities was confirmed.
This week, the medical institution where the clinical trial was conducted will conduct a field investigation to evaluate the possibility of error or intervention of variables. Once this is completed, the last step remains to review safety and effectiveness through external experts.
From next week, the Ministry of Food and Drug Safety plans to open the’Corona 19 Vaccine/Therapeutic Safety and Effectiveness Verification Advisory Group’ consisting of clinical experts focused on infectious medicine and external experts with expertise in the quality field to verify the safety and effectiveness of clinical results. .
After the review of the advisory group is completed, the Central Pharmacy Review Committee, the final gateway to the domestic drug approval review, finally deliberates and recommends the appropriateness of conditional approval. The Ministry of Food and Drug Safety decides on conditional approval based on the recommendations of this advisory group and the Central Pharmaceutical Affairs Commission.
Director Kim Sang-bong said, “We plan to hold a review meeting for the advisory group in which external experts participate,” he said. “We will confirm opinions on the safety and effectiveness, clinical significance, and adequacy of the target patient,” he said.