BRIEF—Full anakinra COVID-19 pneumonia results set up regulator talks

Full results have been presented from the investigator-sponsored SAVE-MORE study of anakinra in COVID-19 pneumonia by Swedish Orphan Biovitrum, the company more commonly-known as Sobi, and the Hellenic Institute for the Study of Sepsis.

Day 28 results show early treatment with anakinra plus standard of care (SOC) reduced mortality by 55% and cut average time until intensive care unit discharge by four days.

There was a near threefold benefit in preventing progression to severe respiratory failure in hospitalized COVID-19 patients with poor prognosis. Anakinra treatment also increased the number of patients discharged from hospital with no evidence of COVID-19 infection, with patients being 2.8 times more likely to fully recover than patients who received placebo and SOC.

Anakinra is an anti-inflammatory drug that targets the cytokines IL-1α/β, which play an important role in COVID-19-induced hyperinflammation. Blocking IL-1α/β at an early stage of disease can have an important impact on COVID-19 disease progression. To date, no drug has been approved for the treatment of the COVID-19 inflammatory response.

Guido Oelkers, chief executive of Sobi, said: “At a time when many countries face huge pressures as they care for extremely ill COVID-19 patients, we are pleased to announce the day 28 full results of the SAVE-MORE study which shows the potential of anakinra to improve patients’ clinical condition when treatment is initiated early and before they require respiratory support. Sobi looks forward to continued dialogue with the European Medicines Agency and other regulatory agencies regarding these results.”