The Consulate of India in Birmingham explores the potential of linking breakthrough UK research initiatives with ongoing projects in the Indian healthcare ecosystem.
Two UK drugs companies will be the first to partner with the Universities of Birmingham and Oxford as part of a major new UK drugs trial to test potential therapeutics to treat patients hospitalised with Covid-19. In what could be a significant development in the fight against the deadly virus, the CATALYST trial will test a series of new drugs, including those already in use for patients with cancer and inflammatory diseases such as rheumatoid arthritis.
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Among them is Izana Bioscience, an Oxford-based biopharmaceutical company headed by British Indian Co-Founder and CEO Dr Someit Sidhu, who believes the company's namilumab drug can play a significant role in dampening the hyper-inflammation seen in patients with severe Covid-19 infection. The second drug, Infliximab (CT-P13) developed by Slough-based Celltrion Healthcare UK, is an anti-tumour necrosis factor (TNF) therapy that is designed to attach to a protein involved in inflammation and is currently used as a treatment for other inflammatory conditions.
“We are committed to working with regulators and partners across the world to ensure this potential therapy can be developed for patients with Covid-19 who urgently need effective treatments,” said Sidhu, inference to Izana Bioscience's drug.
Given his own Indian connect, Sidhu has been keen to explore complementary work taking place in India to link up with this groundbreaking project. The Consulate General of India in Birmingham is leading on this potential new UK-India connect, which could mark a whole new chapter in bilateral healthcare ties.
Consul General Aman Puri said Izana Bioscience's drug offers a lot of hope with its potential to help patients with severe Covid-19 infection.
Dr Puri said: “The Consulate of India acclaims this endeavour as the world struggles to address this humanitarian crisis, which requires countries to collaborate and pool their efforts.
“The Consulate is currently working with Dr Sidhu, who has been an ardent supporter of deeper UK-India healthcare collaboration, to identify and explore suitable opportunities for linking its research initiatives with ongoing projects in the Indian healthcare ecosystem.”
Designed by the Inflammation - Advanced and Cell Therapy Trials Team (I-ACT) at the University of Birmingham's Cancer Research UK Clinical Trials Unit, the CATALYST trial is being run in partnership with University Hospitals Birmingham (UHB) and the Birmingham National Institute for Health Research Biomedical Research Centre (NIHR BRC) and delivered in collaboration with Oxford and University College London NIHR BRC's.
The trial will compare different treatment options against standard of care, to assess their relative effectiveness against Covid-19 and whether any of the drugs being tested slow disease progression or improve survival. Its adaptive trial design will enable the rapid comparison of the multiple interventions simultaneously, with up to 40 patients recruited to each arm. Patients with Covid-19 will be randomly computer allocated to either receive their usual care or usual care with the addition of one of the trial drugs.
Dr Ben Fisher, co-clinical investigator of the CATALYST trial from the University of Birmingham's Institute of Inflammation and Ageing, explains: “There has been a tremendous effort to pull together this initiative so rapidly. Emerging evidence is demonstrating a critical role for anti-inflammatory drugs in the cytokine storm associated with severe Covid-19 infection.
“In the CATALYST study we hope to show with a single dose of these kinds of drugs in hospitalised patients that we are able to delay or prevent the rapid deterioration into intensive care and requirement for invasive ventilation in this critical patient group.”
Namilumab, one of four potential treatments in the trial, is a fully human monoclonal antibody already in late-stage trials to treat rheumatoid arthritis. Researchers in Bergamo and Milan, Italy, began investigating it in April as a potential Covid-19 treatment in a compassionate use study.
It targets a cytokine called GM-CSF (granulocyte-macrophage colony stimulating factor), which is naturally secreted by immune cells in the body but, in uncontrolled levels, is believed to be a key driver of the excessive and dangerous lung inflammation seen in Covid-19 patients.
The trial will determine whether treating patients with Izana Bioscience's namilumab, before they are admitted to intensive care or require ventilation, can control the overactive inflammatory response known as the 'cytokine storm', reducing the risk of serious lung and other organ injury and eventual death.
As the world continues to seek a reliable cure for Covid-19, the latest set of CATALYST trials bring some hope as the effect of each drug will be measured by the amount of oxygen in the blood as well as other severity indicators of the disease - such as organ failure. Drugs that show reductions in the amount of oxygen needed by the patient and in other severity measures will be recommended for further testing within large ongoing national trials.
This is where potential collaborations with a country like India could serve as a possible option for larger test samples.