From Bio Journal - December 2020

Development race for drugs to treat Covid-19

As with the vaccines, the race to develop drugs to treat the novel coronavirus infection, Covid-19, is becoming very heated. Here as well, huge multinational corporations are teaming up with bioventures to push development forward. Existing drugs for Covid-19 include Remdesivir, developed by Gilead Sciences, and Avigan, developed by Fujifilm Group's Toyama Chemical. In antibody drugs, there is one that has become famous due to use by President Trump.

Remdesivir, that led the application of existing drugs, was originally approved as a drug for Ebola hemorrhagic fever, its use being expanded to Covid-19. It was approved in Japan on May 7, 2020 as the first drug to be approved for the novel coronavirus infection.

Remdesivir is an RNA polymerase inhibitor and thus is a drug for viruses whose genes consist of RNA, as with Ebola. When the virus invades a human cell and replicates, the RNA of the genes is synthesized, but as the drug is made to display its effect by blocking the synthesis of the RNA, it was thought to be possible to apply same principle to Covid-19, which also has genes that consist of RNA. If gene synthesis is blocked, naturally gene synthesis cannot take place, and the virus should be unable to replicate. The World Health Organization (WHO), however, announced on October 16 that in a trial involving 11266 subjects, Remdesivir had no impact on either period of hospitalization or death rate. Further, on November 20, WHO advised that Remdesivir not be used due to burdens placed on medical settings arising from the possibility of side effects and the need for intravenous injections.

Fujifilm Group's Toyama Chemical applied for approval of Avigan in October and there is a certain amount of activity occurring in the runup to approval. Also an RNA polymerase inhibitor, this drug was approved as a drug for influenza, which also has genes consisting of RNA, but as there have been serious side effects its use has been limited for influenza. Especially problematic was that in animal trials Avigan resulted in teratogenicity, which causes disorders in newborn animals. In almost all living organisms, when RNA is synthesized through the genetic information in DNA, the polymerase enzyme is at work. If that enzyme is blocked, life phenomena themselves may be threatened and there is a possibility that severe side effects will occur.

One further field in which the development of drugs is being pushed forward is antibody drugs, and perhaps backed up by use by President Trump, permission was given for emergency use of Ely Lilly's antibody Bamlanivimab by the US Food and Drug Administration (FDA) on November 10. However, there has still been little experience with antibody drugs, and it is unknown what kind of side effects may arise. The permission was granted with safety still uncertain for the reason that this is a time of emergency.

As these drug developments are overheating, companies and international organizations issuing warnings about the situation have appeared. Of the world's big three drug makers, the US Pfizer, the Swiss Roche and Novartis, the two Swiss companies are negative about vaccine development and would rather see use made of existing drugs. In a Bloomberg TV interview, Roche's CEO, Severin Schwan, sounded a warning against overheated vaccine development. In addition, WHO and the International Coalition of Medicines Regulatory Authorities (ICMRA), to which many countries including Japan are affiliated, called for restraint on slapdash vaccine and drug development on November 6.

No requirement for notification of genome-edited hybrid offspring

On November 11, 2020, MHLW made the decision to not require notification of genome-edited hybrid offspring but make it voluntary. Hybrid offspring are the result of crossing a genome-edited crop plant with a normal crop plant and therefore the vast majority of foods will be distributed as hybrid offspring. Due to this policy measure, if consumers are not able to know whether a food derives from a genome-edited crop or not, they will have lost the ability to make a choice.

Safety assessment of BASF high-DHA rapeseed begins

MHLW and MAFF both sent an inquiry for safety assessments of the BASF high-DHA rapeseed to the Food Safety Commission in mid-October. The MHLW inquiry concerns human food use and the MAFF inquiry concerns animal feed use. This GM rapeseed, as well as being a high-DHA variety also has imidazolinone herbicide resistance. DHA (docosahexaenoic acid) is one of the omega-3 fatty acids, which are considered to be good for the health. Omega-3s and omega-6s are both essential fatty acids, but due to the issue of excessive consumption of omega-6s, included in soy and corn oils, it is pointed out that omega-3s, in which blue-skinned fish, flaxseed and perilla are plentiful, are under-consumed. As rapeseed also contains little omega-3s, it seems that the idea is to increase the omega-3s and push forward with the cultivation and marketing using "health" as a salespoint. In the US, the cultivation and marketing of high-oleic soy applying genome-editing technology is already moving forward, indicating that GM crop trends are shifting toward "health" foods.

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(English Index)