Biotechnological company BIOCAD received permission from the Ministry of health to conduct clinical trials levelimage in patients with severe coronavirus infection. Domestic original inhibitor of interleukin-6 may be registered at the end of may 2020 through a special procedure.
According to Interim methodological recommendations on the prevention, diagnosis and treatment COVID-19, the results of international studies show that the mortality at COVID-19 is associated, in particular, increased levels of interleukin-6. The obtained data served as the impetus to launch studies on the efficacy of signal pathway inhibitors of interleukin-6 in the treatment of severe and critical pneumonia at COVID-19. A month ago, the US government issued a grant for a clinical trial tocilizumab (registered for the treatment of rheumatoid arthritis in the U.S.) in patients with COVID-19. Levelmap can be a similar domestic measure for the coronavirus.
Levelmap originally developed for the treatment of rheumatoid arthritis and has proven its effectiveness in the framework of phase 1 and phase 2 clinical trials, may obtain expedited state registration due to the fact that its mechanism of action is associated with cytokine storm. However, to confirm its effectiveness that’s when coronaviral infection the company will conduct clinical studies phase III.
Given the epidemic COVID-19, available data on high efficiency of inhibition of signaling pathways of interleukin-6 in the treatment of the complicated course of the infection, and due to the expected growth in the number of patients, including severe forms COVID-19, planned short program in clinical development using adaptive design and the previously obtained data on the pharmacokinetics and pharmacodynamics of a drug. In a growing epidemic of domestic availability of the drug that prevents or relieves the development of severe complications can reduce associated with COVID-19 mortality.