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Biocon’s partner Equillium has said it is planning to conduct a global randomised controlled clinical trial of Itolizumab in COVID-19 patients, for the American biotech firm will record a US investigational new drug application (IND).
Itolizumab, which is used for the treatment of psoriasis, is repurposed for COVID-19, as it regulates the production of inflammatory cytokines or cytokine storm, seen in acute COVID-19 patients at which the immune system attacks the organs, leading to death.
Biocon has out-licensed Itolizumab to US-based Equillium at 2017 for growth in the Usa and Canada. Equillium has been awarded’fast track’ and’orphan drug’ designations for its molecule in both prevention and treatment for Graft versus host disease (GHVD) by the USFDA.
“The outcome of this clinical trial reported by Biocon are encouraging and support the hypothesis that Itolizumab’s novel immune-modulating mechanism could have promise in treating the severe immuno-inflammatory complications experienced from COVID-19 patients,” explained Bruce Steel,” co founder and CEO of Equillium.
“We’re working with Biocon to critique its own entire data set with the objective to maneuver rapidly in discovering appropriate next actions to accelerate further development of Itolizumab to treat moderate to severely ill COVID-19 patients in the united states and overseas at the face of the global crisis,” Steel added.
Kiran Mazumdar-Shaw, Chair Person of Biocon, said that the company is now focussing on India, but if she receives any enquiries from different regions of earth, she’d be looking at that. In case US approval comes through, there’ll be a massive demand for that medication, ” she noted.
On July 11, the DCGI approved restricted unexpected emergency use of Itolizumab injection for treating mild to severe coronavirus disorder (COVID-19) cases. The approval was given based on a randomised, controlled, and open-label study at four hospitals in India, enrolling a total of 30 hospitalised COVID-19 patients having moderate to severe ARDS.
The principal end point was mortality at a month. The business stated that from the Itolizumab arm were no deaths and all patients have recovered; at the control arm three patients died and the rest have regained. The organization claimed that the patients that received Itolizumab also experienced significant reductions in inflammatory cytokines such as IL-6 and TNFα.
“The mortality benefit observed in the Itolizumab arm proved to be statistically significant,” the organization stated.
The medication costs Rs 8,000 each vial
Biocon announced that Itolizumab is going to cost around Rs 8,000 per 25mg/5mL vial. A patient would take four doses of this drug, taking the complete price of the treatment to Rs 32,000.
The two doses of Tocilizumab said to cost about Rs 90,000, and now, there’s a severe deficit of this medication.
“With Itolizumab you can release the individual much earlier, saving the costs of putting people on ventilator, which is quite significant. The cost of Rs 25,000 and Rs 30,000 is hugely beneficial and perhaps not pricey,” Mazumdar-Shaw said.
She added that the distribution is going to be done through a close channel to ensure that there is no recreation of the drug into the blackmarket.
“We would ensure that there isn’t any question of folks hoping to blackmarket it. If we find any such activities we’ll require strong actions. We are ramping up capacity as far as possible as soon as you can make it available to India first,” Mazumdar Shaw added.
Itolizumab was initially developed by Cuba’s state-owned research lab, Centre for Molecular Immunology. The molecule was created for treating cancers such as lymphomas and leukaemia, however it’d found usage in autoimmune disorders, where the immune system attacks your system. Biocon licensed the medication a few 20 decades back and invested significant time and tools to developing and making the medication.
Cuba is using the drug to treat patients.
