Tony Hagen is senior managing editor for The Center for Biosimilars®.
India's medical authorities approve Biocon Biologics' itolizumab, an anti-CD6 IgG1 monoclonal antibody, for emergency treatment of cytokine release syndrome in patients with coronavirus disease 2019 (COVID-19).
An anti-CD6 IgG1 monoclonal antibody from Biocon Biologics of Bengaluru, India, has been approved by the Drugs Controller General of India for the emergency treatment of acute respiratory distress syndrome (ARDS) in patients with coronavirus disease 2019 (COVID-19).
Biocon said in a statement that itolizumab (Alzumab), long used for treatment of acute psoriasis, was approved in injectable form, 25 mg/5 mL, for use in India for the treatment of cytokine release syndrome in patients with moderate-to-severe ARDS. The repurposed drug was originally launched in India in 2013 for treating chronic plaque psoriasis.
Itolizumab “has proven to be an efficacious intervention in treating the serious hyper-immune response seen with COVID-19,” said Kiran Mazumdar-Shaw, executive chairperson of Biocon, in a company statement. Mazumdar-Shaw said the results came from a randomized controlled study of Itolizumab that focused on safety and efficacy in preventing CRS in patients with ARDS due to COVID-19.
“It is the world’s first anti-CD6 novel biologic therapy to be approved for treating patients with moderate-to-severe COVID-19 complications,” Biocon said.
Results of the Trial
The company said the primary end points of reduced mortality were met, as were secondary end points for efficacy and biomarkers. “The data are compelling and I am confident that this ‘first-in-class’ biologic will save lives and help reduce the mortality rate in our country,” Mazmundar-Shaw said.
COVID-19 has been observed to stimulate a strong immune response leading to CRS, which is a “storm” of cytokines that can damage the lungs and other organs. In worst-case scenarios, the outcomes can be multiple organ failure and death.
In the trial, all patients treated with itolizumab responded positively and recovered. There were deaths in the control arm that did not involve treatment with itolizumab. A 1-month mortality rate was measured.
Sandeep Athalyze, chief medical officer for Biocon, said that the drug succeeded in increasing oxygen saturation (absorption) in patients without requiring the increase of oxygen flow (artificial source oxygen). “All the patients on the Itolizumab arm were weaned off oxygen by day 30, and none needed ventilator support, unlike the control arm,” he said.
Inflammation markers such as IL-6, umor necrosis factor—alpha, serum ferritin, d-dimer, lactate dehydrogenase, and C-reactive protein showed clinically significant suppression after dosing and correlated well with symptom improvement and chest x-ray findings. “Itolizumab was overall well tolerated and was found to be safe. Itolizumab when administered to patients with moderate to severe ARDS due to COVID-19 prevents morbidity and mortality due to cytokine storm,” Athalyze said.
The company statement included testimonials from doctors in hospitals in India who said that comparable treatments for COVID-19—related CRS do not exist and that the results in patients treated with itolizumab had been impressive.
“Patients who were with initial oxygen saturation of less than 80%, and would have been put on ventilator support with little chance of survival, recovered completely when treated with Itolizumab and got discharged,” said Suresh Kumar, medical director of Lok Nayak Hospital in Delhi.
Biocon recently announced plans to take its biosimilar unit public.