COVID-19 drug developed by Biokhimik submitted for clinical trials

Promomed 22 June 2020
Biokhimik JSC delivered a pilot batch of Areplivir, a drug of own development with active ingredient favipiravir, to the Medical Institute of the Mordovian State University and Mordovian clinics for study

  Dmitry Zemskov, Executive Director of Biokhimik JSC:

  - Today is a very important day for our company: we have taken another step in the fight against COVID-19. Today we are starting clinical trials of our own drug Areplivir with favipiravir as active ingredient.

Favipiravir was developed in Japan quite a long time ago, about 20 years have passed, and was approved for the treatment of Ebola virus and atypical influenza viruses. This substance has not been produced in our country. However, the extensive and positive experience of using this drug against COVID-19 in the People's Republic of China attracted attention and inspired hope that this drug will help people with COVID-19.

  There are now about 50 pharmaceutical companies in the world competing in the development, improvement and production of this drug. Biokhimik JSC is at the forefront of global trends.

  Our specialists worked day and night, in three shifts, without holidays and weekends, in order to create this drug, which so important in the fight against coronavirus infection, as soon as possible. In almost a month, the employees of our company have developed a technology for the production of substance, carried out all analytical studies and produced a stock of the drug for clinical trials, which are very important. They should be carried out as soon as possible, because in the conditions of the epidemic, Areplivir may turn out to be a drug of hope, choice, a drug of salvation.

Today our drug will be delivered to the clinics of Mordovia for studies, and today we will be able to provide real help to people undergoing therapy for coronavirus infection. The trials enroll about 100 such patients in total.

Helping people is the primary task of both medical personnel and us, specialists of the pharmaceutical industry. We hope that our development will allow Russian citizens to cope with the infection more efficiently, easily and quickly.

  The production facilities of Biokhimik JSC will fully cover the needs of our country in this drug. We are also thinking about the prospect of exporting Areplivir, but now it is more important for us to help the people in Russia.
Larisa Balykova, doct. med. sci., Professor, Corresponding Member of the Russian Academy of Sciences, Director of the Medical Institute of the Mordovia State University:

  Today our institute has received a new antiviral drug Areplivir. Together with practicing doctors, we will study its efficacy and safety in patients with coronavirus infection in the clinic.

  Analogues of this drug are very well and deeply studied in animal studies. Favipiravir has been shown to be highly effective in people with coronavirus infection, in particular, a large study was conducted in China, in Wuhan Province, where the first outbreak of COVID-19 occurred. It has been found that this drug has high antiviral activity and minimal side effects compared to other drugs that are used in the fight against coronavirus infection, and even surpasses many of them. Elimination of the virus from the body within 3-4 days is an excellent result. Thus, we will enable our patients to recover faster, and our doctors to discharge them faster.

  We are not saying that this drug is a panacea in the fight against coronavirus infection, but definitely, it has a new unique mechanism of action, blocks the coronavirus RNA and thereby prevents its reproduction, and also leads to its death due to irreversible mutations.  

It is no coincidence that it was the Mordovian company Biokhimik JSC that was able to develop this drug. In our republic all necessary conditions have been provided for the development of medical science, practice, and drug production, which made it possible to build this unique chain – from the laboratory and production to practice.

We plan to start studies in the near future, with the participation of several clinics. I think we will be ready to give a consolidated opinion in two months. Then Russia will receive an effective instrument to combat the pandemic.

Vyacheslav Shchapov, Chief Physician of the Republican Clinical Hospital of Mordovia:

  In the near future, Areplivir, on which we lay our high hopes, will be delivered to our hospital for wide clinical use. The treatment regimens approved by the Ministry of Health of Russia are already working quite effectively, but in combination with new developments, especially those that have proven to work well in China, treatment will be more effective: the time of patients' stay in the hospital and the severity of their condition will decrease. It is gratifying to know that this Russian drug is produced at our Mordovian enterprise, Biokhimik JSC, which means that there will be no problems with the supply of the drug.