Sobi as well as the Hellenic Institute for the Study of Sepsis have just announced successful results from their SAVE-MORE study for those with COVID-19. The results were from 28 days of investigation of anakinra in combination with standard of care.
The study found that the combination of these treatments led to a reduction in time spent in the ICU, a discharge shorter by 4 days, and a reduction of mortality of 55%.
This study was the first large, randomized trial to investigate a therapeutic for COVID-19 patients at risk for severe disease. This Phase 3 trial included 606 patients who were all currently hospitalized. There were a total of 40 trial locations in Italy and Greece. All patients had pneumonia (either moderate or severe).
Anakinra has anti-inflammatory effects and targets cytokines IL-1a/B. COVID-19 becomes severe when an individual has an extreme reaction called a cytokine storm. Therefore, blocking cytokines at the early stage can have an extremely positive impact for patients.
This therapy has previously been approved for rheumatoid arthritis, neonatal-onset multi system inflammatory disease (NOMID), deficiency of interleukin-1 receptor antagonist (DIRA), cyropyrin-associated periodic syndromes (CAPS), adult-onset Still’s disease (AOSD), Still’s disease, familial cold auto inflammatory syndrome (FCAS), systemic juvenile idiopathic arthritis (SJIA), familial mediterranean fever (FMF), Muckle-Wells syndrome (MWS), and chronic infantile neurological, cutaneous, and articular syndrome (CINCA).
Early treatment with anakinra was found to –
- Prevent severe respiratory failure
- Increase proportion of patients discharged
- Increase the chance of recovery by 2.8 times compared to those who weren’t given anakinra
- 55% reduction of mortality
- Overall clinical status improvement by 64%, particularly for those with severe pneumonia
- Reduction in ICU stay
- Positive results were visible by day 14 on the therapy
Importantly, there were fewer AEs when patients were treated with anakinra than when patients were not. Mild AEs were very comparable across both groups.
Sobi is currently in discussion with regulatory agencies such as the EMA to work toward getting this therapy approved for COVID-19.
You can read more about this investigative therapy for COVID-19 patients here.