Biocon's partner Equillium has said it is planning to conduct a global randomised controlled clinical trial of Itolizumab in COVID-19 patients, for which the American biotech firm will file a US investigational new drug application (IND).
Equillium is basing the decision to conduct the global study on encouraging topline results of the Biocon study and subsequent approval of the Drug Controller General of India (DCGI) to treat COVID-19 patients.
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 serious COVID-19 patients where the immune system attacks the organs, leading to death.
Biocon has out-licensed Itolizumab to US-based Equillium in 2017 for development in the US and Canada. Equillium has been awarded ‘fast track’ and ‘orphan drug’ designations for the molecule in both prevention and treatment of graft-versus-host disease (GHVD) by the USFDA.
“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,” said Bruce Steel, co-founder and CEO of Equillium.
“We are working with Biocon to review its full dataset 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 US and abroad in the face of this global crisis,” Steel added.
Kiran Mazumdar-Shaw, Chairperson of Biocon, said the company is right now focussing on India, but if she gets any enquiries from other parts of the world, she would be looking at that. If US approval comes through, there will be a huge demand for the drug, she noted.
On July 11, the DCGI approved restricted emergency use of Itolizumab injection for treating moderate to severe coronavirus disease (COVID-19) cases. The approval has been granted based on a randomised, controlled, open-label study at four hospitals in India, enrolling a total of 30 hospitalised COVID-19 patients with moderate to severe ARDS.
Twenty patients were randomised to receive Itolizumab plus supportive care, while 10 patients in the control group received supportive care alone. The primary endpoint was mortality at one month. The company said that in the Itolizumab arm there were no deaths and all patients have recovered; in the control arm three patients died and the remaining have recovered. The company claimed that the patients who received Itolizumab also experienced significant reductions in inflammatory cytokines such as IL-6 and TNFα.
"The mortality benefit observed in the Itolizumab arm was statistically significant," the company stated.
The drug costs Rs 8,000 per vial
Biocon announced that Itolizumab will be priced around Rs 8,000 per 25mg/5mL vial. A patient would require four doses of the drug, taking the total cost of the treatment to Rs 32,000.
Itolizumab will be an alternative to Tocilizumab , an IL-6 inhibitor drug marketed by Roche and its Indian partner Cipla. Two doses of Tocilizumab said to cost about Rs 90,000, and currently, there is a severe shortage of the drug.
"With Itolizumab you can discharge the patient much sooner, saving the costs of putting people on ventilator, which is very high. The cost of Rs 25,000 and Rs 30,000 is hugely beneficial and not expensive," Mazumdar-Shaw said.
She added that the distribution will be done through a close channel to ensure that there is no diversion of the drug to the black market.
"We would ensure that there is no question of people trying to black-market it. If we find any such activities we will take strong action. We are ramping up capacity as much as possible and as fast as possible to make it available to India first," Mazumdar-Shaw added.
Itolizumab was originally developed by Cuba's state-owned research laboratory, Centre for Molecular Immunology. The molecule was developed for treating cancers like lymphomas and leukaemia, but it had found use in autoimmune disorders, where the immune system attacks the body. Biocon licensed the drug some 20 years ago and invested significant time and resources for developing and manufacturing the drug.
Cuba is already using the drug to treat patients.