-
Day 28 full results from the SAVE-MORE study show early treatment with anakinra plus SOC (standard of care) reduced mortality by 55% and reduced average time until ICU (intensive care unit) discharge by four days
- In patients treated with anakinra plus SOC, overall clinical status improved by 64% compared to those treated with SOC alone
-
The SAVE-MORE trial, conducted by the
Hellenic Institute for the Study of Sepsis , is the first large, pivotal randomised controlled trial to specifically evaluate a target patient population with COVID-19 at risk of progressing and demonstrating the benefit of earlier intervention with anakinra for the prevention of disease progression and reduced risk of mortality
SAVE-MORE is the first study to specifically evaluate COVID-19 patients at risk of SRF prior to ICU admission with the objectives of preventing disease progression or death and enhancing disease resolution. The trial assessed patients with moderate or severe pneumonia and specifically identified those at risk of SRF by the measurement of elevated suPAR (soluble urokinase plasminogen activator receptor), a plasma biomarker and prognostic tool that reflects early immune activation and has been previously associated with poor prognosis in various conditions. Co-administered treatments were similar between the two arms and included dexamethasone, anticoagulants and remdesivir.
"With excessive inflammatory response to COVID-19 infection being a leading cause of disease progression and mortality, there is an urgent need for medications that can target this hyperinflammation and prevent its evolution. The SAVE-MORE trial confirms a significant reduction in COVID deaths of 55% and also the prevention of severe respiratory failure and ICU admission in at risk patients with COVID related pneumonia, when treated early with anakinra and standard of care versus standard of care alone. The results show that the risk of critical illness can be reduced through early treatment," said lead investigator Evangelos J. Giamarellos-Bourboulis, Professor of Internal Medicine and Infectious Diseases,
COVID-19 infection can be severe and lead to death due to an overreaction of the infected person's inflammatory response, often referred to as a "cytokine storm". Anakinra is an anti-inflammatory drug that targets the cytokines IL-1-/β, which play an important role in COVID-19-induced hyperinflammation. Blocking IL-1-/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.
"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 EMA and other regulatory agencies regarding these results," said
Analysis of the primary end point, the comparative 11-point
For the same group of anakinra treated patients there were reductions in the number of patients
patients allocated to SoC and anakinra treatment. The positive changes to overall improvement and reduced progression to SRF or death were apparent at day 14.
In the SAVE-MORE study, the incidence of serious treatment-emergent adverse events (TEAEs) was lower in patients treated with anakinra and SOC than patients
About SAVE-MORE
SAVE-MORE (NCT04680949); suPAR-Guided Anakinra Treatment for Management of Severe Respiratory Failure by COVID-19) is a large, pivotal, confirmatory, phase III randomized controlled trial (RCT) in over 600 hospitalised patients. The trial aims to evaluate the efficacy and safety of early start of anakinra guided by suPAR in patients with LRTI by SARS-CoV-2 in improving the clinical state of COVID-19 over 28 days, as measured by the ordinal scale of the 11-point
About SAVE
In the SAVE study (NCT04357366), patients with lower respiratory tract infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at high risk for progression to serious respiratory failure were detected using the suPAR biomarker. Early treatment began with anakinra 100 mg/day SC for up to 10 days in the effort to prevent progression in serious respiratory failure. The study is open label, single arm and will include a total of 1,000 patients. 130 patients were included in a preliminary analysis. The analysis of the SAVE study at Day 14 showed that early treatment with anakinra as guided by the suPAR biomarker significantly decreased the incidence of severe respiratory failure in COVID-19 patients with pneumonia compared to a matched control cohort[iii]. The SAVE study is an investigator sponsored study conducted independently by Professor Giamarellos-Bourboulis, with the
About Kineret® (anakinra)
Kineret® is an interleukin-1 - and β receptor antagonist that is indicated in the US for reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis, in patients 18 years of age or older
In
For full US prescribing information visit www.kineretrx.com and for full European prescribing information visit the EMA website. Anakinra has not been approved for the treatment of COVID -19.
About suPAR and suPARnostic®
suPAR (soluble urokinase plasminogen activator receptor) is the biomarker detected by
About the
Contact details: Evangelos J. Giamarellos-Bourboulis egiamarel@med.uoa.gr;
About Sobi
Sobi is a specialised international biopharmaceutical company transforming the lives of people with rare diseases. Sobi is providing sustainable access to innovative therapies in the areas of haematology, immunology and specialty indications. Today, Sobi employs approximately 1,500 people across
For more information, please contact
Paula Treutiger, Head of Communication & Investor Relations
+ 46 733 666 599
paula.treutiger@sobi.com
+ 46 767 248 830
maria.kruse@sobi.com
[i]https://medrxiv.org/cgi/content/short/2021.05.16.21257283v1
[ii] Lancet Infect Dis 2020, Published Online
[iii] Early suPAR-guided anakinra decreased SRF and restored the pro-/anti-inflammatory balance
Postal address SE-112 76
Phone: 46 8 697 20 00 www.sobi.com
https://news.cision.com/swedish-orphan-biovitrum-ab/r/early-use-of-anakinra-reduces-risk-of-mortality-for-patients-with-covid-19-pneumonia--reduces-icu-ad,c3350835
https://mb.cision.com/Main/14266/3350835/1420371.pdf
(c) 2021 Cision. All rights reserved., source