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Results from Celltrion clinical phase 2, which shortens the treatment period by more than 3 days in patients with moderate disease
Phase 3 study, it is necessary to evaluate the effect of mild patients, it is difficult to hope that the effect will end with the flare itself
Celltrion announced that it has significantly reduced the incidence of critically ill patients and recovery time by announcing the results of phase 2 clinical trials for COVID-19 antibody treatment, and that there were no safety concerns. However, the experts noted that although the effect of reducing progression from mild to severe has been confirmed, there are fewer clinical participants, so additional studies are needed to demonstrate 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, development 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.
Furthermore, it was emphasized that the general consistency of the clinical data showed more effective results in patients with moderate severity or 50 years of age or older, including in reducing the severe incidence and the clinical recovery time.
The announcement of the clinical results was carried out for 30 minutes starting at 6 pm by Professor Um Joong-sik from Gil Hospital of Gachon University, 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 of last year (24 days abroad, local time), and this clinical result shows that the infection for corona virus 19 was finally confirmed just before medication. A total of 307 patients with mild and moderate symptoms were analyzed. Patients with moderate disease were patients with pneumonia and represented approximately 60% of the total population.
54% of all patients and 68% of moderately ill patients older than 50 years compared to placebo based on the defined dose (40 mg / kg) of Rekyrona at the incidence rate of mild and moderate patients who they progress to severe and require hospital treatment. Diminished. The time to show clinical recovery was 5.4 days in the Rekyrone group and 8.8 days in the placebo group.
In particular, in patients over 50 years of age with moderate or severe symptoms, the time it takes to show clinical recovery when taking Rekirona injection was reduced by more than 5-6 days compared to the placebo group.
Furthermore, 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 Rekironaju, and the placebo group was found to reach the virus concentration of the 7th day of the group treatment only after the tenth day.
Overall, the result of the safety assessment did not show any details in the Rekirona treatment group. There were no serious adverse reactions, deaths, or study discontinuation due to adverse events after administration of the investigational drug.
Joong-sik Eom, professor of infectious medicine at Gachon University Gil Hospital, said: “Reekyronaju demonstrated through this clinical trial that when administered to patients with mild and moderately severe corona19, the rate of development in severely severe patients sickness was significantly reduced and recovery at a rapid rate. ” I believe that both vaccines and treatments are fundamental options to prevent the spread of the Corona 19 epidemic and make the situation worse. “
Results from Celltrion’s phase 2 clinical study show that in patients older than 50 years with pneumonia, it has been shown to reduce hospital stays, hospitalizations and the need for oxygen therapy, allowing experts to partially reduce the burden of treatment . Evaluated.
Jae-hoon Jeong, Professor in the Department of Preventive Medicine, Gachon University School of Medicine, said: “In phase 2, it has been confirmed that patients older than 50 years with pneumonia have the effect of reducing hospital stays. , hospitalization and oxygen therapy requirements. This will reduce the burden on the medical system when antibody therapy is used correctly. “It means it can be done,” he noted that “the lack of research subjects requires a phase 3 study to fully test the effect, and a separate evaluation of the effect is needed, especially for mildly confirmed cases.”
Experts believe it is difficult to expect the effect of ending the Corona 19 epidemic as an antibody treatment. For this reason, it is emphasized that it is more important to comply with vaccination or quarantine regulations. Furthermore, since this study is not a cross-drug comparison study, 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 antibody treatment is not to reduce the death rate of seriously ill patients, the effect of reducing the death rate is not considered in this study, so it is not can be evaluated. ” Suppression of symptom onset in confirmed asymptomatic patients cannot be demonstrated by this study, so further studies are needed. ”
Professor Jeong also revealed that this study is not a cross-drug comparative study, so the effect compared to other drugs cannot be said.
Not only Celltrion, but also Regeneron from 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 developing antibody treatments.
In this regard, however, Professor Jeong pointed out that “the comparison between drugs must be made within the same clinical trial, so that all conditions are equal.” “The results of research abroad reflect the characteristics of the country, so comparative studies with different conditions do not make sense.” .
Looking at the clinical results of antibody treatments performed at home and abroad so far, experts say that vaccination or compliance with quarantine regulations is more important in the end, because you cannot wait for the end of Corona 19 as antibody treatment.
Professor Jeong said: “The antibody treatments that have been studied so far can reduce some of the burden on the medical system and provide a sense of security that there are means of treatment, but there are no changes in the basis of the policies of quarantine such as social distancing and vaccination. ” After all, it means 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 Pharmaceutical Safety based on the results of this phase 2 study.
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