Celltrion clinical phase 2 results, shortening the treatment period by more than 3 days in patients with moderate symptoms
Phase 3 study, need to evaluate the effect of mild patients, it is difficult to expect the effect of ending the outbreak itself
Celltrion announced that it has significantly reduced the incidence of severe patients and the time to recovery through the announcement of the results of phase 2 clinical trials for COVID-19 antibody treatment, and that there was no problem with safety. However, experts pointed out that although the effect of reducing the progression from mild to severe has been confirmed, there are fewer clinical participants, so additional studies are needed to prove the effect more reliably.
Celltrion, at the ‘2021 High1 New Drug Development Symposium’ held on the afternoon of the 13th, showed the results of the global clinical phase 2 of the Corona 19 antibody treatment’Recyronaju (ingredient name Regdanvimab, developed name CT-P59)’. It was revealed that the presence of early pneumonia plays a very important risk factor for worsening symptoms, and in this case, Rekirona can be used as a more effective treatment.
In addition, it was emphasized that the overall consistency of clinical data showed more effective results in the patients with moderate severity or 50 years of age or older, even in the reduction of severe incidence and time to clinical recovery.
The announcement of the clinical results was conducted for 30 minutes from 6 pm by Professor Um Joong-sik of Gachon University Gil Hospital, who participated in the clinical trial.
A total of 327 patients from Korea, Romania, Spain, and the United States participated in the clinical trial and completed the final medication on November 25 last year (24 days overseas local time), and this clinical result shows that the corona 19 virus infection was finally confirmed just before the medication. A total of 307 patients with mild and moderate symptoms were analyzed. Patients with moderate illness were patients with pneumonia, accounting for about 60% of the total population.
54% of all patients and 68% of moderately ill patients over 50 years of age compared to placebo based on the defined dose (40 mg/kg) of Rekyrona at the incidence rate of mild and moderate patients developing to severe requiring inpatient treatment. Decreased. The time to show clinical recovery was 5.4 days in the Rekyrona-treated group and 8.8 days in the placebo-treated group.
In particular, in patients with moderate or severe symptoms over 50 years of age, the time it takes to show clinical recovery when taking Rekirona injection was shortened by more than 5-6 days compared to the placebo group.
In addition, the virus concentration in the body was significantly lower than that of the placebo group due to the rapid reduction of the virus in the body when taking Rekirona injection, and it was found that the placebo group reached the 7th day virus concentration of the treatment group only after the 10th day.
Overall, the safety evaluation result did not show any specifics in the Rekirona treatment group. There were no serious adverse reactions, deaths, or discontinuation of the study due to adverse events after administration of the investigational drug.
Joong-sik Eom, a professor of infectious medicine at Gachon University Gil Hospital, said, “Reekyronaju proved through this clinical trial that the rate of development into severely ill patients when administered to mild and moderate corona19 patients is significantly reduced and recovers at a rapid pace.” I think that vaccines as well as treatments are essential options to prevent the spread of the corona 19 epidemic and worsening the situation.”
The results of Celltrion’s Phase 2 clinical study show that in patients over 50 years of age with pneumonia, it has been shown to reduce hospital stays, hospitalization, and the need for oxygen therapy, allowing experts to partially reduce the burden of treatment. Evaluated.
Jae-hoon Jeong, a professor at the Department of Preventive Medicine, Gachon University School of Medicine, said, “In phase 2, it has been confirmed that patients over 50 years of age with pneumonia have reduced hospital stays and reduced hospitalization and oxygen therapy requirements. “It means that it can be done,” he pointed out that “the lack of research subjects requires a phase 3 study to fully prove the effect, and a separate evaluation of the effect is needed especially for mildly confirmed cases.”
Experts believe that it is difficult to expect the effect of ending the epidemic of Corona 19 itself as an antibody treatment. For this reason, it is emphasized that it is more important to comply with vaccine or quarantine regulations. Also, since this study is not a comparative study between drugs, they also suggested that it is inappropriate to mention the effect compared to other antibody treatments such as Lily and Regeneron.
Professor Jeong Jae-hoon said, “Because the purpose of the antibody treatment is not to reduce the mortality rate of severely ill patients, the effect of reducing the mortality rate is not considered in this study, so it cannot be evaluated.” “Inhibition of infection in contact, which can be suggested as another use of antibody therapy, The suppression of symptom onset in asymptomatic confirmed patients cannot be proved through this study, so additional studies are needed.”
Prof. Jeong also said that because this study is not a comparative study between drugs, the effect compared to other drugs cannot be said.
Not only Celltrion, but also Regeneron of the United States and Lily, a multinational pharmaceutical company, are developing antibody treatments. In this study, Celltrion revealed that Lily and Regeneron were more effective than antibody treatments under development.
In this regard, however, Professor Jeong pointed out that “comparison between drugs must be made within the same clinical trial, so that all conditions become equal.” “Overseas research results reflect the characteristics of the country, so comparative studies with different conditions are meaningless.” .
When looking at the clinical results of antibody treatments conducted at home and abroad so far, experts say that vaccination or compliance with quarantine regulations is more important in the end, because the end of Corona 19 as an antibody treatment cannot be expected.
Professor Jeong said, “The antibody treatments that have been studied so far can relieve some of the burden on the medical system and provide a sense of security that there are treatment means, but there is no change in the basis of quarantine policies such as social distancing and vaccination.” In the end, it means that not getting caught is more important than treatment after infection.”
On the other hand, Celltrion plans to apply for emergency approval of antibody treatments to the Ministry of Food and Drug Safety based on the results of this phase 2 study.
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