ASOURCE Navi

Vaccination, which is considered to be the pillar of countermeasures against the new coronavirus, is progressing, and a silver bullet is desired for the end of the disease, but the development of therapeutic drugs has not progressed as expected so far. Recently, the development of therapeutic drugs for new coronavirus infections has progressed, and drugs that can treat mild to severe symptoms are gradually becoming available. In Japan, four drugs were approved by mid-July this year as treatments for the new coronavirus. In addition, we aim to apply for approval of several therapeutic agents under development by the end of the year.

Drugs that can be used from the mild stage, which accounts for about 80% of new corona infections, are Chugai's "Lonapreve Intravenous Infusion Set 300" and "Same Set 1332" (generic names: casilibimab and imdevimab). On July 19th this year, the Ministry of Health, Labor and Welfare granted special approval. It will be the first drug in Japan developed from the beginning to treat the new coronavirus. The drug is a simultaneous infusion of two virus-neutralizing antibodies, casilibimab and imdevimab. The new coronavirus binds to human cells, invades them, and proliferates, but in this treatment called "antibody cocktail therapy," two types of antibodies administered by intravenous drip combine with the virus, allowing it to enter cells. Deter intrusions. As a result, it is a mechanism that prevents the virus from multiplying and reduces the risk of becoming severe. Subjects are hospitalized patients with mild to moderate illness who do not require oxygen administration and have risk factors for exacerbation such as age, obesity, and underlying diseases. Overseas clinical trials have shown that the risk of hospitalization or death is reduced by approximately 70% compared to the non-administered group. In addition, it has been confirmed in non-clinical studies that it is effective against multiple mutant strains, including the delta strain. This drug became a hot topic last year when former US President Trump was infected with Corona.

Three drugs have been approved for moderate to severe COVID-19, many of which are repurposing existing drugs developed for other diseases. Gilead Sciences' remdesivir was developed as a treatment for Ebola hemorrhagic fever. In clinical trials, the percentage of patients who recovered from the start of administration to day 14 was 74.4% in the remdesivir group and 59.0% in the standard treatment group. At 14 days, mortality was 7.6% in the remdesivir group and 12.5% in the standard-of-care group. Dexamethasone, which is manufactured by Nichi-Iko and other companies as a generic product, is a steroid drug approved for the treatment of severe infections and interstitial pneumonia. Certified without In a UK clinical study, the mortality rate for patients requiring mechanical ventilation was about 40% in the standard care group compared with about 29% in the dexamethasone group. Eli Lilly Japan's baricitinib is a rheumatoid arthritis drug that suppresses symptoms by inhibiting the JAK (Janus kinase) enzyme involved in the inflammatory response. In April of this year, special approval was granted for moderate to severe patients. When the new corona becomes severe, an excessive immune reaction may occur and cause organ damage, but this drug has the effect of suppressing inflammation caused by immune abnormalities.

In addition, several domestic companies are aiming to apply for approval of therapeutic drug candidates by the end of the year. Actemra, a rheumatoid arthritis drug developed by Chugai Pharmaceutical, was approved by the U.S. Food and Drug Administration (FDA) in June this year as an emergency treatment for corona for severely ill patients using ventilators and ECMO (extracorporeal membrane oxygenation). Get permission to use. Clinical trials have already been completed in Japan, and we plan to apply for approval by the end of the year. The drug has the effect of suppressing excessive immune reactions, and a reduction in the risk of death has been confirmed in clinical trials in the United Kingdom. Fujifilm Toyama Chemical applied for approval of Avigan, an anti-influenza drug it developed last autumn, but due to problems with the clinical trial method, it was continued to be discussed as ``it is difficult to judge the efficacy''. For this reason, we will once again conduct a clinical trial targeting patients aged 50 and over who are at high risk of developing severe disease, and plan to complete the trial by this autumn. Kowa plans to conduct clinical trials in Japan for the antiparasitic drug ivermectin, which has been confirmed to be effective in suppressing the growth of the new coronavirus and has anti-inflammatory effects, targeting mildly ill patients, aiming to apply for approval within the year. Furthermore, on July 26, Shionogi & Co. announced that it had started a clinical trial (trial) of an oral drug to treat the novel coronavirus. This drug suppresses the growth of the new coronavirus by selectively inhibiting 3CL protease, an enzyme essential for the growth of the new coronavirus. In clinical trials, we plan to administer the drug to healthy subjects and verify its safety. The timing of clinical trials and approval applications for the second stage and beyond is undecided.