Limerick biomedical firm tests drug on first coronavirus patient outside USA

Nick Rabbitts

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Nick Rabbitts

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Limerick biomedical firm tests drug on first coronavirus patient outside USA

Regeneron employs 1,000 people at its base in the Raheen Industrial Estate | PICTURE: MICHAEL COWHEY

A LIMERICK-based biomedical company which is developing a potential new aid for coronavirus patients has tested its first person outside the USA.

Regeneron, which has its European headquarters in Raheen is working alongside fellow pharmaceutical giant Sanofi on a global clinical programme evaluating Kevzara, an antibody it hopes will assist in the treatment of coronavirus.

Put simply, Kevzara inhibits IL6, a type of protein, which may play a role in driving the immune response that causes acute respiratory distress syndrome.

It’s the second project to aid Covid-19 patients Regeneron is progressing, with work still ongoing on another cocktail, which may provide a treatment to the deadly condition.

Coronavirus, which originated in Wuhan, China, has claimed the lives of more than 35,000 people worldwide – including 46 here in Ireland as of Sunday night.

Regeneron, which employs 1,000 in Limerick, has tested the first patient on its Kefzara programme, and assessments of the drug are going on in Italy, Spain, Germany, France, Canada, Russia and the United States, where the firm’s global headquarters is.

It’s the second phase of the programme, and Regeneron and Sanofi are working with health authorities worldwide to identify new testing sites.

George D Yancopolous, the co-founder, president and chief scientific officer of Regeneron said: “Data from a single-arm study in China suggest that the interleukin-6 pathway may play an important role in the overactive inflammatory response in the lungs of patients with Covid-19. Despite this encouraging finding, it's imperative to conduct a properly designed, randomized trial to understand the true impact of Kevzara, which we are now doing through this global clinical trial program.”

Kevzara is a fully-human monoclonal antibody that inhibits the pathway of the interleukin-6 (IL6) protein. It does this by binding and blocking the IL-6 receptor. IL-6 may play a role in driving the overactive inflammatory response in the lungs of patients who are severely or critically ill with Covid-19 infection.

John Reed, Sanofi’s global head of research and development added: “Sanofi and Regeneron are relentlessly working to rapidly initiate trials around the world that will help determine whether Kevzara has the potential to play a role in addressing the Covid-19 disease global health crisis. These trials will provide important data to determine whether Kevzara ameliorates the life-threatening complications of Covid-19 infections by counteracting the overactive inflammatory immune responses in the lungs when damaged by the virus.”

The trial outside of the U.S. will assess the safety and efficacy of adding a single intravenous dose of Kevzara to usual supportive care, compared to supportive care plus placebo. The trial has an adaptive design with two parts and is anticipated to enrol approximately 300 patients. It will recruit hospitalised patients from several countries who are severely or critically ill with Covid-19 infection.

Scientists have preliminary evidence that IL-6 may play a key role in driving the inflammatory immune response that causes acute respiratory distress syndrome (ARDS) in patients critically ill from coronavirus. In an initial, non-peer-reviewed case series from China, a 21-patient cohort of COVID-19 patients experienced rapidly reduced fevers, and 75% of patients (15 out of 20) reduced their need for supplemental oxygen within days of receiving another IL-6 receptor antibody (tocilizumab). Based on these results, China updated its COVID-19 treatment guidelines and approved the use of that IL-6 inhibitor to treat patients with severe or critical disease.