The COVID-19 pandemic has had a profound impact on the world, leading to significant loss of life and widespread economic disruption. The need for effective treatments and vaccines to combat the virus is critical. Biocon, a leading biopharmaceutical company, has developed a drug called ALZUMAb® (Itolizumab) to treat COVID-19.
ALZUMAb® (Itolizumab) is a humanized monoclonal antibody drug that has been used in India for several years to treat psoriasis, a chronic skin disease. In June 2020, the Drug Controller General of India (DCGI) approved the use of ALZUMAb® (Itolizumab) for emergency use in COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS).
ALZUMAb® (Itolizumab) works by binding to a specific protein called CD6 that is expressed on the surface of T cells, a type of immune cell. By binding to CD6, ALZUMAb® (Itolizumab) prevents the activation and proliferation of T cells, which can lead to an excessive immune response or cytokine storm in COVID-19 patients. A cytokine storm can cause severe lung damage and respiratory failure, leading to a high mortality rate in COVID-19 patients.
Biocon conducted a Phase II clinical trial of ALZUMAb® (Itolizumab) in COVID-19 patients with moderate to severe ARDS. The trial enrolled 30 patients, of which 20 received ALZUMAb® (Itolizumab) and 10 received standard of care. The results of the trial showed that ALZUMAb® (Itolizumab) significantly reduced the mortality rate in COVID-19 patients with moderate to severe ARDS. The mortality rate in the ALZUMAb® (Itolizumab) group was 15%, compared to 40% in the standard of care group.
In addition, ALZUMAb® (Itolizumab) improved oxygenation and reduced inflammation in COVID-19 patients. The drug was well-tolerated with no significant adverse events reported.
The Phase II clinical trial of ALZUMAb® (Itolizumab) was followed by a Phase III clinical trial, which enrolled 30 patients with moderate to severe COVID-19. The results of the Phase III trial are pending.
ALZUMAb® (Itolizumab) has shown promising results in clinical trials for treating COVID-19 patients with moderate to severe ARDS. The drug works by binding to CD6 and preventing the activation and proliferation of T cells, which can cause a cytokine storm in COVID-19 patients. ALZUMAb® (Itolizumab) has been approved for emergency use in India, and its safety and efficacy are being studied in ongoing clinical trials. If the results of the Phase III trial are positive, ALZUMAb® (Itolizumab) could be a valuable treatment option for COVID-19 patients.