New Delhi: Drug Itolizumab — touted by Cuba as a possible therapy to prevent deaths due to Covid-19 — could be India’s new bet against coronavirus.
The drug will go under clinical trials in six hospitals.
Monoclonal antibody Itolizumab is a molecule that started developing in a joint venture by Indian drug major Biocon in collaboration with the Centre for Molecular Immunology (CIM). The CIM is a cancer research institute located on the west side of Havana, Cuba.
However, Biocon obtained the licence for the drug as an early stage asset from the CIM, and the company’s scientific team then started developing the antibody for auto-immune diseases in 2006 in India. Later, after successful patient studies, the drug was approved for commercialisation in India for Plaque Psoriasis in 2013 under the brand name ALZUMAb.
Biocon has now received the permission to repurpose the drug for Covid-19 from the Indian drug regulator. The company will check the drug’s efficacy for an “anti-CD-6 IgG1” monoclonal antibody in moderate to severe patients with Covid-19 complications.
“Itolizumab has been used in India for some years now and its safety has been established. Our partners in Cuba, the one with whom the company started developing the drug, have used this drug on Covid-19 patients. The initial data from them looks quite promising,” said Dr Sandeep Athalye, senior vice-president and chief medical officer, Biocon Biologics.
“The drug inhibits the production of pro-inflammatory cytokines, which leads to acute respiratory distress syndrome and multi-organ failure among Covid-19 patients. We believe that ‘cytokine storm,’ which is a complication of Covid-19, can thus be treated with Itolizumab,” he added.
The trials of the drug will be conducted in New Delhi, Mumbai and Bengaluru. The chosen sites in New Delhi are All India Institute of Medical Sciences (AIIMS) and Lok Nayak Jai Prakash Narayan Hospital, according to the government’s portal Clinical Trial Registry of India (CTRI).
In Bengaluru, Narayana Health will conduct the trials, and in Mumbai, KEM Hospital, B.Y.L. Nair Charitable Hospital and Dr Balabhai Nanavati Hospital will do the trials.
Athalye is leading the trials in all these six hospitals.
AIIMS, New Delhi, has already begun the trials, while Dr Balabhai Nanavati Hospital and Narayana Health are likely to start soon once the eligible patients are enrolled, according to officials leading the trials in these hospitals.
The rest are also in the process of beginning the trials. The estimated duration of the trials is three months.
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Details of the trial
It is an open label trial, which means no information will be hidden from the researchers and participants about the course of the treatment administered.
According to the details of the trial published on the CTRI portal, all eligible patients entering into the study will be randomised in 2:1 ratio to receive the treatment A and B, respectively. It means group A will have twice the people in group B.
While treatment A would mean best supportive care along with Itolizumab, treatment B means best supportive care, which includes other therapies such as antivirals, antibiotics, hydroxychloroquine or oxygen therapy.
“The best supportive care will be as per institution standard,” according to the CTRI website.
“As Itolizumab is an investigational drug, the benefit to Covid-19 patients experiencing complications such as Cytokine Release Syndrome (CRS) is not known. However, findings from this study may be beneficial to society at large at the national and international level,” according to the brief summary of the trial on the portal.
The CRS is an over response by the immune system in which the body’s own immunity attacks healthy tissues.
The primary outcome of the trial will analyse one-month mortality rate between the two groups.
How Cuba used itolizumab?
Cuba, last week, said “use of two drugs produced by its biotech industry that reduce hyper-inflammation in seriously ill Covid-19 patients has sharply curbed its coronavirus-related death toll”.
Out of the two drugs touted as possible reasons behind low mortality, one is Itolizumab. The country reported only two deaths in the last nine days with over 200 active cases.
Cuba believes the drug “appears to help calm the cytokine storm, a dangerous over response by the immune system in which it attacks healthy tissue as well as the invading virus”.
According to a news report by Reuters: “Scientists caution that large placebo-controlled studies are needed to assess the safety and efficacy of these drugs for treating Covid-19.”
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