Celltrion Corona Clinical Announcement… Why was the’Virus Negative’ missing?

-In the announcement of the results of Phase 2 clinical trials of Celltrion’s antibody treatment, which is expected to be the first Korean COVID-19 treatment, the result of “shortening the period of virus vocalization”, which was initially set as the main point (primary evaluation variable) of the drug efficacy evaluation, aroused curiosity. The negative pre-negative period is the period of time it takes to transition from positive to negative when testing for viruses.

On the 13th, Professor Eom Joong-sik, a professor of infectious medicine at Gachon University Gil Hospital, said the result of Global Corona 19 Phase 2 of Celltrion’s’Recyronaju’ (ingredient name Legdanvimab, development name CT-P59) at the ‘2021 High1 New Drug Development Symposium’ at the Korean Pharmacy Society conference. Announced.

As a result of a study of 327 patients with mild to moderate illness, Rekyronaju shortened the’time to clinical recovery’, which is another common criterion, by 3 days or more compared to the placebo group. In particular, it was shortened by 5.1 days in patients with moderate illness (with pneumonia) and by more than 6.4 days in patients with moderate illness over 50 years old. It shows greater benefits in high-risk groups.

In addition, the incidence rate (hospitalization rate) of patients with mild and moderate symptoms, which was set as a secondary indicator (secondary endpoint), develops to severe, was lowered by 54% compared to placebo. It was lowered by 68% for those over 50. However, the announcement did not include how much shorter the time it takes to switch from positive to negative when testing for a virus, another popular mark. In the press release, only the content that’the virus concentration in the body was significantly lower as of 7 days compared to the placebo group’ was presented as the rate of reduction of the virus in the body was significantly faster when taking Rekirona. Initially, Celltrion and the Ministry of Food and Drug Safety discussed the efficacy of the drug and set it as a common reference to see the efficacy of the drug. Celltrion explained that further discussions on the standard of negative warfare were needed, and that the US did not include it in the announcement because it was not used as an approval standard.

An official from Celltrion said, “How much the virus concentration should be set to be considered’negative’ is a part that needs further discussion. He said that he is currently in discussion with the Ministry of Food and Drug Safety, and “it was not included in the announcement because it is in discussion.”

He continued, “The US-approved antibody treatment system did not view the reduction of the virus negative duration as the main reason for the approval. Is distorted. In fact, for this phase 2, the prestige of clinical trials was different for each country, and the overall severity of the incidence was an important indicator.”

[서울=뉴시스]