Swedish Orphan Biovitrum AB (Sobi) and the Hellenic Institute for the Study of Sepsis have reported positive data from the Phase III SAVE-MORE clinical trial of anakinra plus standard of care (SOC) in moderate-to-severe Covid-19 pneumonia patients.
Kineret or anakinra is an interleukin-1 α and β receptor antagonist.
The drug is intended for reducing the signs and symptoms, as well as structural damage progression in moderately to severely active rheumatoid arthritis.
Conducted by the Hellenic Institute for the Study of Sepsis, Sobi funded the trial and offered the drug needed to conduct the study.
The large, pivotal, confirmatory, randomised, controlled Phase III trial enrolled 606 hospitalised Covid-19 patients at 37 trial centres in Greece and Italy.
It evaluated the efficacy and safety of early anakinra intervention guided by soluble urokinase plasminogen activator receptor (suPAR) in patients with Covid-19-associated lower respiratory tract infections (LRTI) to improve the clinical state of the disease over 28 days.
The improvement was assessed using the ordinal scale of the 11-point World Health Organization clinical progression scale.
The trial subjects were randomised into a 2:1 ratio to receive a 100mg daily subcutaneous dose of anakinra plus SOC or a placebo plus SOC for up to ten days.
Co-administered treatments included dexamethasone, anticoagulants and remdesivir.
According to data from the investigator-sponsored trial, early and targeted use of anakinra plus SOC reduced mortality risk and intensive care unit (ICU) admission.
Furthermore, the drug boosted chances of complete recovery in hospitalised Covid-19 patients with reduced prognosis due to severe respiratory failure risk.
Anakinra demonstrated substantial efficacy and lowered disease progression and mortality risk by 64% and offered a relative mortality reduction of 55% and reaching 80% for patients with a cytokine storm.
More than half of the subjects receiving the treatment recovered and the number of subjects with severe disease declined by 54%, Sobi noted.
Average time to hospital and ICU discharge was lowered by one and four days, respectively.
Sobi CEO Guido Oelkers said: “Publication of the SAVE-MORE study results in Nature Medicine demonstrates the significance of these data and further advances our understanding of the role of IL-1 in Covid-19.
“We hope to contribute to an improvement of care for patients during this critical time and welcome the opportunity to work closely with the EMA and other regulatory agencies regarding these results.”
Earlier, Sobi received a public cash offer from Advent International and GIC affiliate, Aurora Investment, valuing the company at nearly $8bn (Skr69.4bn) or $27.33 (Skr235) per share.