Input 2021.01.06 11:45 | Revision 2021.01.06 13:59
Green Cross, Chong Kun Dang, SK Chemicals, Daewoong, NG Chem, Immunmed, clinical trials for severe cases
Green Cross, Chong Kun Dang, apply for permission for use in the first quarter… Daewoong, preparing 3 drugs
Kim Tak, a professor of infectious medicine at Soonchunhyang University, Bucheon Hospital, said in a conversation with this magazine on the 6th, “In the United States, there have been studies showing that antibody treatments (such as Eli Lilly, a pharmaceutical company) do not affect severe improvement.” “I don’t think it will become a’game changer’ that will change the Corona 19 situation,” he said. Antiviral drugs that kill viruses like antibody treatments will be effective in the early stages of infection, but after a week or so after infection, severe symptoms such as pneumonia appear due to inflammatory reactions caused by the virus or excessive immune response (cytokine storm) of the body. Another drug is needed to compensate.
According to the Ministry of Food and Drug Safety on the day, Green Cross, Chong Kun Dang, Daewoong Pharmaceutical, among 12 domestic companies that are undergoing clinical trials for COVID-19 treatment in KoreaSK chemicals (285130)·NG Chem Life Science (183490)· Six sites, including Immunmed, are conducting clinical trials for severely ill patients.
Green Cross said on the day that “the domestic phase 2 experiment of the blood system drug, which was conducted on 60 patients on the 31st of last month, has ended,” and said, “I will apply for conditional permission to the Ministry of Food and Drug Safety as soon as the results are available.” The blood system drug is a drug made by extracting a neutralizing antibody called “immunoglobulin” in the plasma (liquid remaining after separating solid components such as red blood cells and white blood cells from the blood) of a cure for Corona 19. Neutralizing antibodies play a role in lowering infectivity and toxicity by binding with the spike (projection) protein on the surface of the Corona 19 virus.
Through the’Treatmental Use Approval’ system, which allows emergency patients to use drugs that have not undergone clinical trials at the judgment of medical staff, the largest number of 30 domestic COVID-19 treatment candidates were used. According to the company, last month, a severely ill patient in his 70s at Chilgok Kyungpook National University Hospital was given this drug and was cured.
Napamostat is being studied as a treatment for Corona 19, with higher antiviral efficacy than remdesivir, reducing inflammatory response, and inhibiting blood coagulation. This drug prevents severe symptoms such as pneumonia and blood clots (blood clots) that interfere with blood circulation and increase the risk of death.
Daewoong Pharmaceutical has established a multi-variety strategy that can increase the possibility of final marketing by simultaneously conducting domestic and international clinical trials of three severe treatments. The company entered the third phase in Korea on the 31st of last month with a combination of Pancreatitis treatment Hoysta tablet (ingredient name Camostat) and Ebola treatment remdesivir. In the case of drugs that have already been marketed as treatments for other diseases, the fast-track system, which allows users to skip phases 1 and 2 and enter phase 3 immediately, is the most advanced in clinical standards among severe treatments.
Like Napamostat, camostat is a drug that has been reported to have better antiviral efficacy than remdesivir through domestic and international research institutes. An official of Daewoong Pharmaceutical said, “If remdesivir is used in combination with this drug, it is expected to create synergistic effects such as preventing the spread of the virus throughout the body by interfering with the penetration of the corona 19 virus into the body through the respiratory tract.” Explained.
Daewoong Pharmaceutical is conducting phase 1 drugs in Korea and Indonesia, respectively, of niclosamide and stem cell treatment (DWP710), which are expected to relieve other severe symptoms. Stem cell therapy, which will enter clinical trials in Korea this year, is known to have the effect of preventing a cytokine storm, which increases the risk of death among young people.
In addition to Daewoong Pharmaceutical, Kangstem Biotech, Immunmed, Jambags & Caral, SCM Life Science, and Phamicell are not conducting clinical trials separately, but their stem cell treatments are being used for some patients through approval for therapeutic use. Cytokine storm is a phenomenon in which the immune system reacts excessively when a virus infiltrates into the body and attacks organs in the body.
NG Chem and Immunmed are also conducting phase 2 in Korea respectively. ENGCHEM’s immunomodulators cannot eliminate viruses, but they are known to prevent cytokine storms by regulating the immune system so that excessive immune responses do not occur. Immunmed’s drug’HzVSF-v13′, which was developed as a treatment for flu and hepatitis B infection, was also researched to have antiviral and anti-inflammatory effects and was published in the international academic journal’Journal of Medical Virology’ last year.
In the future, clinical trials for severe treatments are expected to proceed as planned or delayed depending on the patient recruitment situation. According to the Korea Centers for Disease Control and Prevention, as of 0 o’clock on this day, a total of 411 patients with severe corona19 disease in Korea. As dozens or more than 100 patients per clinical trial are needed, it may take some time for several clinical trials to fill the entire recruitment population. “We originally tried to recruit 100 severely ill patients, but we are discussing with the Ministry of Science and ICT (supporting clinical trials) how to reduce the recruitment to 50 patients,” said Lim Jae-seok, vice president of NewG Lab, which is conducting the Hutan clinical trial of SK Chemicals. Told.