Equillium Inc (NASDAQ:EQ) and its partner Biocon Limited have announced favorable findings from a clinical trial of itolizumab as a treatment for cytokine release syndrome (CRS).
The clinical trial was conducted in India, and the findings from the study indicate that itolizumab was able to achieve a significantly lower mortality rate in COVID-19 patients suffering from acute respiratory distress syndrome (ARDS). Equilibrium also revealed that the positive results also allowed the treatment to secure emergency use case approval from India’s medicines regulator, Drugs Controller General of India (DCGI).
The restricted emergency use authorization will allow itolizumab to be used as a treatment for cytokine release syndrome (CRS) in COVID-19 patients. It will especially be used in patients that have severe or mild ARDS. The encouraging results from the clinical studies of itolizumab conducted by Biocon in India are enough to encourage Equillium to pursue a controlled and randomized global clinical study of itolizumab. The company also plans to file for an investigational new drug application (IND) with the FDA in the U.S.
“The results of this clinical trial reported by Biocon are encouraging and support the hypothesis that itolizumab’s novel immune-modulating mechanism may have promise in addressing the severe immuno-inflammatory complications experienced by COVID-19 patients,” stated Equillium CEO Bruce Steel.
The CEO also revealed that Equillium and Biocon are working towards reviewing the full data set from the study. This will help them determine the next course of action and shift the treatment’s development into high gear. The company’s overall goal is to secure regulatory approval so that the itolizumab can be used in the U.S and across the world to treat severely ill COVID-19 patients.
Siddhartha Mukherjee, a clinical advisor for Biocon Equillium, stated that the development of new treatments that help extremely ill patients to survive is extremely important especially with the ongoing pandemic. Promising treatments such as itolizumab are vital because they provide a fighting chance for people suffering from ARDS and other respiratory illnesses.
Most COVID-19 patients suffer from respiratory failure as the immune system releases too many inflammatory proteins into the bloodstream. This causes organ and tissue damage, and the lungs are among the most affected organs.