Regeneron and Sanofi will amend their ongoing trial of sarilumab (Kevzara) to enroll only “critical” hospitalized patients with COVID-19.
Regeneron and Sanofi will amend their phase 3 trial evaluating sarilumab (Kevzara) in hospitalized patients with “severe” or “critical” illness caused by coronavirus disease 2019 (COVID-19) to include only “critical” patients, according to a press release.
Although currently approved for the treatment of rheumatoid arthritis, sarilumab, an interleukin-6 (IL-6) receptor antibody, is being investigated for its ability to reduce the overactive inflammatory immune response associated with COVID-19, according to Regeneron. This is based on evidence of markedly elevated levels of IL-6 in severely ill patients with the virus.
The ongoing portion of the phase 3 trial, which is continuing to enroll, currently includes more than 600 patients with “critical” illness.
In the randomized phase 2 portion of the study, intravenously-administered sarilumab was assessed in 457 hospitalized patients who were categorized as either having “severe” illness (28%), “critical” illness (49%), or “multi-system organ dysfunction (MSOD) (23%). Patients were classified as having “severe” illness if they required oxygen supplementation without mechanical or high-flow oxygenation and “critical” if they required mechanical ventilation or high-flow oxygenation or required treatment in an intensive care unit.
Patients in the study received either a higher dose of sarilumab (400 mg), lower dose (200 mg), or placebo.
According to preliminary results, sarilumab was shown to rapidly lower C-reactive protein (CRP), a marker of inflammation, meeting the primary endpoints. Baseline levels of IL-6 were elevated across all treatment arms, with higher levels observed in the “critical” group compared with the “severe group”. No new safety signals were observed, according to the study.
There was no notable benefit on clinical outcomes when combining the “severe” and “critical” groups versus placebo; however, the study demonstrated negative trends for most outcomes in the “severe” group” and positive trends for all outcomes in the “critical” group.
Following a review by the Independent Data Monitoring Committee of all available data, the trial will be immediately amended so that only “critical” patients continue to be enrolled to receive sarilumab 400 mg or placebo, according to Regeneron.
Results from the phase 3 trial are expected by June.
1. Regeneron and Sanofi Provide Update on US Phase 2/3 Adaptive-Designed Trial of Kevzara® (Sarilumab) in Hospitalized COVID-19 Patients. News Release. Regeneron; April 27, 2020. Accessed April 27, 2020. https://investor.regeneron.com/news-releases/news-release-details/regeneron-and-sanofi-provide-update-us-phase-23-adaptive.