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Alexion, following clues from early tests, preps phase 3 study of Ultomiris in severe COVID-19

For about two months, Alexion has been exploring whether its Soliris—used to treat several rare diseases—might hold promise in treating patients with severe COVID-19, the illness caused by the novel coronavirus. But on Monday, the company said it was starting a phase 3 trial of Ultomiris, a similar medicine it launched last year. 

Alexion reached out to federal authorities back in February about the possibility of using Soliris, a drug that inhibits part of the body’s immune system, in treating COVID-19 patients who are also suffering from severe pneumonia or acute respiratory distress syndrome. At the time, the company said there was “preclinical scientific rationale” to believe Soliris might be able to help certain COVID-19 patients. By inhibiting the complement portion of a patient’s immune system, the drug might play a role in stopping an immune response that actually makes the illness worse, researchers have said.

Fast forward to Monday, and Alexion said it’s starting a phase 3 trial of Ultomiris—the follow-up drug to Soliris—in COVID-19 patients with severe pneumonia or acute respiratory distress syndrome. The global trial will enroll about 270 patients.  

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In deciding to start the trial, Alexion cited preclinical data that show that the inhibition of terminal complement can lower cytokine and chemokine levels, plus reduce lung inflammation. The company says it knows of ongoing or planned studies by independent investigators, and that early results warrant a controlled clinical test. 

As for the decision to test Ultomiris rather than Soliris, the company says the newer drug is the “future” of its drug class, and that less frequent dosing can lower healthcare burdens. Plus, the company can make the drug at a higher capacity.  

RELATED: Alexion plans phase 2 study of Soliris in COVID-19 in coming days: report 

Meanwhile, a small study of Soliris is examining mortality, time in intensive care and time on a ventilator for patients who receive the medicine, according to info posted on ClinicalTrials.gov. 

“While this virus is the provocateur, it is often the patient’s own disproportionate immune response which deals the most devastating (and often fatal) damage,” the study summary says. “A specific part of the immune system, known as the complement, has been shown to cause such damage in other types of coronaviruses.” 

In starting the new study, Alexion becomes the latest drugmaker to explore whether an existing medicine might be able to help patients with COVID-19. An effective therapy is seen as one key component to being able to reopen economies.

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