Biotech company Regeneron said its rheumatoid arthritis drug Kevzara failed to meet the main goals of a US study testing it in the most critically ill Covid-19 patients
The company, which has a major industrial operations centre in Limerick, was working in partnership with French pharmaceutical company Sanofi on the trial. Previous trial results had also shown that the drug did not help patients with less severe Covid-19, the disease caused by the novel coronavirus.
Kevzara belongs to a class of drugs called interleukin-6 inhibitors that are being tried to help regulate a dangerous overreaction to the virus by the body’s immune system called “cytokine storm.”
Other drugs in the same class, including Roche Holding AG’s Actemra, are also being studied as treatments for Covid-19.
A separate Sanofi-led trial of Kevzara outside of the United States in hospitalised patients with severe and critical Covid-19 using a different dosing regimen is ongoing, the companies said.
Patients who required mechanical ventilation or high-flow oxygen therapy or treatment in an intensive care unit were considered critically ill. Those who required oxygen without mechanical or high-flow oxygenation were considered severely ill.
Worldwide, the virus has infected 10.76 million people, resulting in 516,600 deaths.
Headquartered in New York, Regeneron employs almost 1,000 people in the former Dell factory in Raheen.
Their facility in Limerick manufactures a range of biopharmaceuticals for patients worldwide, including the company’s approved therapeutic proteins and those involved in clinical studies.
Last month Regeneron began human trials of a separate Covid-19 treatment. The company is advancing its antibody “cocktail” treatment called REGN-COV2 designed to prevent and treat the Sars-CoV-2 virus.
Regeneron’s cocktail — which contains an antibody made by the company and a second isolated from humans who recovered from Covid-19 — is designed so that its two antibodies bind to the coronavirus’ spike protein, limiting the ability of viruses to escape.
The company said the treatment for Covid-19 could be available as soon as this autumn with plans to scale up its manufacturing to produce 200,000 doses per month by the end of summer.
To meet the timeline will “depend on a lot of factors,” including whether the treatment works as well as hoped, “and there is obviously a lot of risk,” Regeneron Chief Scientific Officer George Yancopoulos said.
Regeneron said that in order to enable its US manufacturing site to produce large-scale quantities of REGN-COV2, they were working with the US Food and Drug Administration to accelerate the licensing of additional commercial products manufactured in Limerick.