The drug has recently gathered criticism regarding phase 2 clinical trial that enrolled 31 patients only. Director-General of the ICMR Balram Bhargava said at a Health Ministry press briefing on July 14, that ”There is yet no evidence from trials that itolizumab and tocilizumab, two drugs, one of which itolizumab has been developed by Bengaluru-based Biocon Biologics, reduce death in severely ill coronavirus (COVID-19)patients”, according to The Hindu newspaper.
On July 11, Biocon Limited announced that the Drugs Controller General of India approved its drug Itolizumab “for emergency use in India for the treatment of cytokine release syndrome (CRS) in moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19.
The drug is priced at ₹32,000 for a treatment course and ₹8000/vial.
Itolizumab is an anti-CD6 IgG1 monoclonal antibody developed by Biocon and the Center of Molecular Immunology (CIM), Havana and introduced in India in 2013 under the brand name ALZUMAb to treat chronic plaque psoriasis.
Itolizumab’s acts via immunomodulation. It binds to the CD6 receptor and blocks the activation of T lymphocytes, in turn suppressing the pro-inflammatory cytokines and decreasing the cytokine storm and inflammatory response.
Dr Jammi Nagaraj Rao, a public health physician, independent researcher and epidemiologist in the UK, wrote for The Wire Science:
[Biocon’s] trial is seriously deficient in its design. Its defects – particularly the extremely small sample size – largely invalidate the claims made in the press release from Biocon … The researchers have also not published data that would allow independent experts to assess their claim in the press release, that “Itolizumab demonstrated statistically significant advantage over the control arm, in one month mortality rate”. With such data and without further larger trials, it is difficult to see how the company can fulfil its ambition to “take this therapy to other parts of the world impacted by the pandemic”. … The irony is that Itolizumab may well be a breakthrough. If it is and if its real effects can be shown conclusively in a large trial, then Biocon would be able to boast of an unbeatable product. As things stand, it is unlikely to make that breakthrough without much greater rigour in the science of clinical trials.