Initially, the drug was developed to treat rheumatoid arthritis. BIOCAD developers receive regulatory authorization as part of the procedure approved by Decree No. 441 of the Government of the Russian Federation of April 4, 2020 since the mechanism of action of the active substance is associated with the cytokine storm, a life-threatening immune system response in patients with COVID-19. To confirm its efficacy in the treatment of coronavirus infection, the company starts organizing phase 3 clinical trials. The Ministry of Health of the Russian Federation approved the participation of 11 healthcare centers in the clinical trials of the Russian drug with the INN levilimab. Let us remind that, according to the Interim Guidelines for the Prevention, Diagnosis and Treatment of COVID-19 of the Ministry of Health of Russia, mortality in COVID-19 is associated, inter alia, with an increase in interleukin-6 levels.
According to Nikita Lomakin, Chief Researcher, Central Clinical Hospital of the Presidential Administration of the Russian Federation, a positive and almost unique characteristic of the clinical trial protocol is that the study includes patients with moderate disease with first clinical signs of respiratory failure. "Not only a molecule new to COVID infection, but a fundamentally different approach to managing these patients compared to current recommendations allows not treating but preventing the development of the cytokine storm. Moreover, based on the experience of our center, it seems that the main predictor of its development is not the laboratory data, but the clinical course of the disease. The use of levilimab at the very beginning of clinical manifestations of respiratory failure helps prevent the necessity to transfer patients to the intensive care unit. We managed to discharge 10 out of 36 patients as early as on day 7-8, with 1 patient being transferred to intensive care," the doctor said.
Currently, healthcare institutions such as the Federal State Budgetary Educational Institution of Higher Education Bashkir State Medical University and O.M. Filatov Moscow City Clinical Hospital No. 15 (Department of Health of the city of Moscow, Ministry of Health of the Russian Federation) have joined the clinical trials of levilimab. It is planned that in the near future, after receiving accreditation, North Caucasian sites, such as the State Budget Institution of the Republic of Dagestan "Republican Clinical Hospital", and SFI "Sh.Sh. Ependiev Republican Clinical Hospital" (Republic of Chechnya) and others will join the project.
"Within a single day, on May 7, just a few days after the publication of the forthcoming start of clinical trials of the inhibitor levilimab, seven healthcare institutions expressed their wish to participate in the trials", said Dmitry Morozov, CEO of the Biotech Company BIOCAD. "Such high specialists' confidence in the domestic drug is for us, among other things, an indicator that we have chosen the right strategy and our new drug can greatly help people with coronavirus complications in the near future."
Levilimab is the Russian original IL-6 receptor inhibitor. Previously, the biotech company BIOCAD received approval from the Ministry of Health to conduct a clinical study of levilimab in patients with severe coronavirus infection.