(NIH.gov)
24 Mar. 2020. A clinical trial is beginning soon that tests a current drug for rheumatoid arthritis as a treatment for severe pneumonia in patients with Covid-19 infections. Genentech, the biotechnology division of drug maker Roche, says the Food and Drug Administration authorized the trial of the biologic therapy tocilizumab, marketed as Actemra, for patients with severe cases of pneumonia from novel coronavirus, or Covid-19 infections.
While the global Covid-19 pandemic is spreading, quickly in some regions, health care facilities are becoming overwhelmed with patients, forcing scarce resources to be concentrated on the most severe cases. Among these severe cases are individuals where the virus infects the lungs and airways, causing inflammation that can lead to pneumonia. Health authorities are eager to find current drugs that may be able to treat this condition, short-cutting the normal development process for new drugs that can take months or years.
Tocilizumab is a synthetic antibody approved by FDA to treat moderate to severe rheumatoid arthritis, an autoimmune disease, where the immune system is tricked into attacking healthy cells, that leads to inflammation of joints — wrists, fingers, feet, and ankles — and surrounding tissue. The antibody, given as an intravenous infusion, blocks a protein called interleukin 6, or IL-6, associated with chronic inflammation and autoimmunity. Tocilizumab is also authorized for treating some juvenile forms of arthritis and giant cell arteritis, a condition causing inflammation of blood vessels.
The late-stage clinical, says Genentech, is conducted with the Biomedical Advanced Research and Development Authority, or BARDA, an agency of the U.S. Department of Health and Human Services. The study, set to begin in early April, aims to test tocilizumab with the standard of care for Covid-19 pneumonia against the standard of care with a placebo. Researchers plan to track participants for 60 days following treatment, although interim results will be provided if early evidence of efficacy emerges. Those efficacy factors include clinical status, mortality, and need for mechanical ventilation or treatment in an intensive care unit.
As reported last week by Science & Enterprise, biotechnology company Regeneron Pharmaceuticals and drug maker Sanofi are testing their synthetic antibody sarilumab, also a therapy for rheumatoid arthritis blocking IL-6, to treat patients with acute respiratory distress syndrome, a severe form of Covid-19 infections, as a way to reduce lung inflammation. The companies cite results from a small-scale trial of tocilizumab in China that show reductions in fevers and less need for supplemental oxygen among the 21 participants with severe Covid-19 infections.
In addition, Genentech is donating 10,000 vials of tocilizumab to the U.S. Strategic National Stockpile, if the U.S. needs these drugs later on. The company says the availability of tocilizumab for current individuals needing the drug will not be affected.
Alexander Hardy, CEO of Genentech, says in a company statement, “We thank the FDA for rapidly expediting the approval of this clinical trial to evaluate Actemra in critically ill patients suffering from pneumonia following coronavirus infection and we’re moving forward to enroll as quickly as possible.”
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