[기자수첩]Mixed gaze toward Celltrion corona treatment

Corona 19 vaccine development is becoming visible one after another, but the treatment is slow. Corona 19 treatments are mostly antibody treatments, and research and development are in full swing in Korea. Among them, Celltrion is receiving the most attention. The Ministry of Food and Drug Safety announced the results of the’Corona 19 Treatment/Vaccine Safety and Effectiveness Verification Advisory Group’ meeting on the 18th. It contained the contents of a review of the results of a phase 2 clinical trial of Celltrion’s corona antibody treatment’Rekironaju’.

Briefly, it was found that the period until recovery from the symptoms of Corona 19 was 5.34 days for patients receiving’rekironaju’ and 8.77 days for patients receiving placebo. It is said that the patient who received’Rekironaju’ recovered from the symptoms of Corona 19 as quickly as about 3.43 days. The verification advisory group determined that the result was clinically meaningful in that the time for improvement of Corona 19 symptoms decreased.

In addition, when’rekironaju’ was administered as an auxiliary method for confirming the effectiveness of the drug, the proportion of patients who need hospitalization and oxygen therapy tended to decrease. However, it was suggested that it was difficult to draw a definite conclusion because a separate statistical test method was not determined. The proportion of patients who need hospitalization and oxygen therapy should proceed with phase 3 clinical trials for many patients in the future to determine specific results and meaning. There were no deaths in patients who were treated with’Rekirona’ or those who did not. It means that the effect on mortality is also unknown.

The verification team proposed an item permission for’Rekkironaju’ on the premise of conducting phase 3 clinical trials. It has given power to the possibility that’Rekironaju’ will be approved as the country’s first COVID-19 treatment. Simply looking at the results that the rate of symptom improvement patients has increased, the therapeutic effect of’Rekironaju’ may appear as obvious, but it is not.

Earlier, global pharmaceutical company Eli Lilly was approved by the US Food and Drug Administration (FDA) for emergency use of’Regeneron’ as a treatment for Corona 19 in November last year. In December, one month after Eli Lilly’s urgent approval of the treatment, two deaths per minute occurred. Even in the United States, where corona treatment has been approved, the number of corona deaths has not decreased.

The common thing between Celltrion’s’Rekironazu’ and Eli Lilly’s’Regeneron’ is that it is an antibody treatment and targets mild and moderate corona patients. In the international journals related to medical research last year, reports on the results of research on corona antibody therapy were released one after another. A study conducted in China found that antibody treatment did not lower the mortality rate in severely ill patients. Even in Italy, antibody therapy has not been shown to contribute to recovery of severely ill patients.

Antibody therapeutics attack by attaching antibodies to spike proteins that cause viral infection. This will relieve the symptoms of infection. However, antibody treatments are not effective for severe patients such as pneumonia. The cause of serious symptoms is not a problem with the coronavirus itself, but because the virus damages internal functions such as lungs. Viruses are almost completely eliminated in severely ill patients with impaired body functions. Therefore, it is said that there is little therapeutic effect even if an antibody treatment is applied.

This is why Celltrion and Eli Lilly’s clinical targets for corona treatment are mild or moderate. For this reason, there are high concerns over the approval of Celltrion’s treatment. Health care organizations made statements against the results of the Ministry of Food and Drug Safety’s verification advisory group meeting.

The Federation of Health and Medical Organizations for the Realization of the Right to Health said, “It is clear that evaluating clinical safety and efficacy with only phase 2 clinical trials in the first place is clear.” It will give you a signal.”

Currently, a number of domestic pharmaceutical and bio companies such as GC Green Cross, Bukwang Pharmaceutical, and Shinpoong Pharmaceutical are developing COVID-19 treatments. If the first button is inserted incorrectly, the rest of the buttons will be misaligned. Celltrion treatment is the first button. This is why the industry and the public are drawing attention on whether or not to license Celltrion’s corona treatment.