Welcome to another episode of the Watchlist Series. Today, we take a look at IL-6 Inhibitors, and whether or not, they are the right class of biologic to be testing on Covid-19 Patients.
Regeneron and Sanofi announced that the U.S. Phase 3 clinical trial of Kevzara® (sarilumab) 400 mg in COVID-19 patients requiring mechanical ventilation failed to meet its primary and key secondary endpoints when the drug was added to best supportive care compared to best supportive care alone (placebo). In the primary analysis group, adverse events were experienced by 80% of Kevzara patients and 77% of placebo patients. Serious adverse events that occurred in at least 3% of patients and more frequently among Kevzara patients included multi-organ dysfunction syndrome (6% Kevzara, 5% placebo) and hypotension (4% Kevzara and 3% placebo). The industry sponsors have halted this U.S.-based clinical trial, including a second cohort of patients who received a higher dose of Kevzara (800 mg), based on these findings. Both Regeneron and Sanofi have commented in a press release to submit detailed peer-reviewed disclosure of what happened in this partially publicly financed clinical trial. There are several other Kevzara studies ongoing involving COVID-19 patients: what are the implications of the results from those studies? What about the 43 Actemra (tocilizumab) clinical trials associated with COVID-19 patients and the failed Italian tocilizumab (Actemra) study? Is their growing evidence that pharma company’s pursuit of repurposing IL-6 inhibitors against COVID-19 is a failed strategy? After all, clinical trials are expensive and, as is the case in this U.S., study public funds can be involved. How can these funds be best utilized to protect patients?