Itolizumab “significantly reduced mortality” in hospitalised COVID-19 patients with respiratory distress, secures emergency use authorisation in India
pharmafile | July 13, 2020 | News story | Research and Development, Sales and Marketing | COVID-19, Itolizumab, coronavirus
Itolizumab, a drug currently being developed by biotech firm Equillium for autoimmune and inflammatory disorders, “significantly reduced mortality” in hospitalised COVID-19 patients in an India-based clinical trial, it has emerged.
The study was conducted by Biocon at four Indian hospitals and encompassed 30 hospitalised COVID-19 patients with severe to moderate acute respiratory distress syndrome (ARDS).
No deaths were reported in the 20 patients receiving itolizumab in combination with best supportive care, with all patients recovering, compared to three deaths reported in the 10 patients receiving best supportive care alone, with the remaining seven making a full recovery.
This benefit was deemed statistically significant, and patients receiving itolizumab also demonstrated “significant reductions” in inflammatory cytokines such as IL-6 and TNFα.
“Patients with COVID-19 experience acute respiratory failure caused by the immune system flooding the bloodstream with inflammatory proteins, which can kill tissue, damage organs and pathologically activate clotting cascades in the lungs, heart, and kidneys,” explained Dr Ivor S Douglas, FRCP (UK) Professor of Medicine, Chief of Pulmonary and Critical Care and Medical Director at the Medical Intensive Care Denver Health Medical Center.
“The novel mechanism of itolizumab, which works by inhibiting CD6 to reduce the activation and trafficking of pathogenic T cells that release pro-inflammatory cytokines, may be well suited to address SARS-CoV-2 induced inflammation that drives respiratory failure in patients with COVID-19.”
Based on the data, the Drugs Controller General of India (DCGI), India’s drug regulator, has authorised the therapy for restricted emergency use in the country in the treatment of cytokine release syndrome (CRS) in COVID-19 patients with moderate to severe ARDS.
Bruce Steel, co-founder and CEO of Equillium, said the company was now working with Biocon to review the full data from the recent study, “with the goal to move swiftly in determining appropriate next steps to accelerate further development of itolizumab to treat moderate to severely ill COVID-19 patients in the U.S. and abroad in the face of this global crisis.”
Matt Fellows
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