Today the company Equillium reported that clinical trials of their drug itoizamub “significantly reduced mortality” in patients with COVID-19. Equillium is a clinical-stage biotechnology company whose focus is largely COVID-19-related – like many companies of this sort at the moment. They reported today that a Biocon, India clinical trial with itolizumab “significantly reduced mortality in patients hospitalized with COVID-19.”
As noted by a release from Biocon, the official Drugs Controller General of India has granted restricted emergency use of itolizamub for the treatment of cytokine release syndrome (CRS) in COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS).
Per Equillium, based on encouraging results from the latest Biocon study and the DCGI approval for COVID-19 patients, they’ll be running a “global randomized controlled clinical trial” of their drug itolizumab. They’ll also be filing a U.S. investigational new drug application (IND) for this drug.
Biocon’s trial was a “randomized, controlled, open-label study at four hospitals in India, enrolling a total of 30 hospitalized COVID-19 patients with moderate to severe ARDS.” according to a release by the company this week. Equillium is partner to Biocon, who out-licensed Itolizumab to the group back in 2017 for development in the US and Canada. Biocon reported the following trial results this week:
• In the itolizumab arm there were no deaths and all patients have recovered; in the control arm three patients died and the remainder have recovered
• The mortality benefit observed in the itolizumab arm was statistically significant
• Consistent with the observed clinical improvement, patients who received itolizumab also experienced significant reductions in inflammatory cytokines such as IL-6 and TNFα
Equallium also announced that their temporary pausing of two “EQUIP” trials has resumed. The trials targeted uncontrolled asthma and the EQUALISE trial for lupus nephritis, and were paused in March of 2020 “as a result of the emerging COVID-19 pandemic.” Today, Equellium announced that patient enrollment in both of these studies has resumed.