Biopharmaceuticals major, Biocon Ltd, is set to roll out the phase-4 post-marketing surveillance for its repurpose drug Itolizumab to treat Covid-19 patients.
It may be noted that the Drug Controller General of India (DCGI) had asked Biocon to revise its clinical trial protocol for conducting phase-4 studies on Itolizumab used to treat Covid-19 patients. This is despite Biocon stating that the trials conducted had proved the drug’s safety and efficacy, a spokesperson for the company told BusinessLine .
“As a part of our commitment to the DCGI, to generate more evidence, we have planned for a Phase IV trial to be conducted across 15-25 hospitals across India. The trial will commence shortly and will recruit 300 patients,” the spokesperson said.
The company also plans to publish all clinical data in peer-reviewed journals for better understanding of the role of Itolizumab in the disease process and its safety and efficacy in patients with Covid-19.
Commenting on Biocon’s repurpose drug Itolizumab, Vinay Bafna, Analyst, ICICI Securities, said: “As per update provided by the company in August, Biocon had completed preliminary tests on Itolizumab for controlling cytokine storm (CKS) indication in 20 patients successfully. At the moment, trials with 1,000 patients are going on and results seem encouraging at the moment. Globally, Equilium is the partner which is conducting early stages of testing for developed markets like the US, Canada, etc.”
Biocon has repurposed its Itolizumab, an anti-CD6 novel biologic for psoriasis, for the treatment of Cytokine Release Syndrome or Storm (CRS) in moderate to severe acute respiratory distress syndrome (ARDS) patients due to Covid-19, based on the results of a pivotal Phase II clinical study. Repurposing a drug means prescribing it for newer indications after tweaking it; in this case for Covid-19, other than what the drug is usually used for.
The company presented the protocol for conducting a phase-4 clinical trial to evaluate the safety and efficacy of Itolizumab dosage of 25 mg/5 ml solution for intravenous infusion in vials to treat CRS in Covid-19 patients suffering from a moderate-to-severe acute respiratory condition.
Restricted use
Itolizumab received ‘Restricted Emergency Use’ authorisation from CDSCO on July 11 and since then over 1,000 patients have been treated with Itolizumab. “ALZUMAb or Itolizumab received restricted emergency use authorization from CDSCO on July 12 and since then the drug has been extensively used across the country with very promising outcomes. In fact, ALZUMAb is the only biologic with a restricted emergency use approval for CRS in Covid-19 patients. Our US partner, Equillium, is also very encouraged by these results and is planning to initiate clinical trials in the US at the earliest,” Biocon’s chairperson and managing director Kiran Mazumdar Shaw had said during an analysts call recently.
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“Lok Nayak Hospital was one of the sites of the Itolizumab study wherein we used Itolizumab to treat eight patients. These patients did extremely well even with a single dose of Itolizumab. Patients who were with initial oxygen saturation of less than 80 per cent and would have been put on ventilator support with little chance of survival, recovered completely when treated with Itolizumab and got discharged,” Suresh Kumar, Medical Director, Lok Nayak Hospital, New Delhi, said.