Phase 3 trial of Ultomiris in severe Covid-19 starts

Alexion is to commence a phase 3 trial of Ultomiris in COVID-19 patients with severe pneumonia or acute respiratory distress syndrome, involving around 270 patients across the world. Ultomiris was launched last year and is the follow-up drug to Soliris which is used to treat several rare diseases. The latter inhibits part of the body’s immune system, and research has shown that by doing so might play a role in stopping an immune response that in fact makes the illness worse. A small study of Soliris is examining mortality, time in intensive care and time on a ventilator for patients who receive the medicine, but Alexion has decided to start a phase 3 trial of Ultomiris because of preclinical data that shows the inhibition of terminal complement can lower cytokine and chemokine levels, plus reduce lung inflammation. Additionally, Alexion believes the newer drug is the “future” of its drug class, that less frequent dosing can lower healthcare burdens, and that they can produce more Ultomiris than Soliris.

The summary of the study states: “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. A specific part of the immune system, known as the complement, has been shown to cause such damage in other types of coronaviruses.”