The year 2020 began with a not-so-great scenario that escalated rapidly into a pandemic that has crippled the functioning of the world. A lot has happened over the course of these past 4 months with a large number of people losing their lives to a microscopic virus. Coronavirus and COVID-19 are words that are familiar to every person in the world since it has made a huge impact on everything that rules people’s hectic lives; Business, economy and simply put, their way of living. The novelty of the virus is a research field in itself with scientists looking into its morphology and genetic structure, discovering new facts about this unknown microorganism. With most of the people who got affected being asymptomatic, scientists also have to work faster to detect the properties of this virus and easier ways to detect it to increase the number of people being tested per day. Therefore, it is a need of the hour for those susceptible to have a vaccine they can rely on that will be effective in helping them develop immunity against this virus. With the rush to develop a vaccine, many countries have applied for their drug compounds to be used for phase 3 or phase 4 trials. COVAX, an initiative by Gavi, a public-private partnership, to support the acceleration of the designing, development, and distribution of vaccines. With countries around the world trying to find a vaccine, about 130 vaccines are under testing in various phases. India is also actively taking part in this vaccine rush and has 2 possible drugs in different trial stages; Covaxin by Bharat Biotech and ZyCov-D by Zydus which are proving to be hopeful. Along with these two, Biocon, a global biopharma company based in Bangalore, recently announced that they have received a green flag from the Drug Controller General of India to release their novel biologic, Itolizumab (ALZUMAb®) into the market for restricted emergency use in treating COVID-19 patients with moderate to severe complications.
But why is Itolizumab, a drug used in treating a chronic skin disease like psoriasis, being used to treat patients affected with COVID-19?
The SARS-CoV-2 virus affects individuals by triggering the immune system to generate a large number of cytokines which can attack the organs like lungs, etc. and can lead to multiple organ failure or death. Here is where Itolizumab seems to help the affected individuals.
Kiran Mazumder-Shaw, the Executive Chairperson of Biocon, said in a press release that this novel drug has been approved by the regulator, based on the promising data obtained from a pivotal two-arm, randomized trial involving 30 eligible patients across New Delhi and Mumbai. Out of these 30 patients, 20 were administered with Itolizumab with the best care, making them the test arm and the remaining 10 were not administered Itolizumab, making them the control arm. After a period of one month, the mortality rates were observed. The results were promising, as all 20 of the test arm patients experienced a full recovery. 3 patients out of the 10 in the control arm died.
Itolizumab proved itself to be efficient by meeting the key efficacy parameter of improving lung function without a hike oxygen flow as required by the patients in the control arm and also displayed suppression or reduction in the expression of clinical markers of inflammation. It has also worked tremendously in controlling moderate to severe ARDS (Acute Respiratory Distress Syndrome) induced by COVID-19 and has shown its efficacy in treating elder patients too. This clinical trial proved to be helpful in giving emergency treatment options to patients to reduce complications. Itolizumab, the psoriasis drug turned COVID-19 treatment, is shown to work best if administered before the cytokine release begins and helps to prevent the cytokine storm from intensifying.
This drug can be the best bet since it already is available in the market for the treatment of psoriasis, implying the fact that it is safe for human usage which has been proven by the 4 phase trials that were conducted before its release in 2013 by Biocon. Itolizumab acts by binding to the CD6 receptor and modulating it to prevent the T-lymphocyte activation thereby reducing the cytokine storm that turns into a deadly immune response.
Biocon is very well known for its unique biologics and pharmaceutical products in India and has a lot of global connections, Equillium being one of them. Equillium, a biotechnology company is planning to initiate a global study of this novel drug, Itolizumab, to make sure a large number of people get benefitted within a short period. Equillium is partnering with Biocon for Itolizumab in U.S., Canada, Australia, and New Zealand.
Bruce Steel, the co-founder, and CEO of Equillium said that they are working with Biocon to assess the further processes involved in accelerating the use of Itolizumab to treat COVID-19 patients in the U.S and abroad. The drug is being evaluated at present under two INDs for treating acute graft-vs-host disease and lupus nephritis, plus a clinical study in uncontrolled asthma in Australia and New Zealand.
Similarly, Itolizumab has been used to treat COVID-19 patients in Cuba too. The reports from Cuba were similar to the one obtained in the trial done in India and it shows a very low mortality rate in the patients who were administered with Itolizumab. The dosage being administered is a 25mg/5ml formulation at the rate of 4 vials per patient. Each vial costs Rs. 7,950. Therefore, the total dosage costs around Rs. 35,000.
The success and approval of Itolizumab show us that we can still hope for a better tomorrow with many individuals carrying out endless research works to find a solution. The efforts are enormous and we can only hope for them to be fruitful. With vaccines under trial and testing, the best we, as general citizens, can do is to stay calm and help others do the same. It is our responsibility to take enough care of our health and in this case, the health of our loved ones too.