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Regeneron and Sanofi Provide Update on U.S. Phase 2/3 Adaptive-Designed Trial of Kevzara® (sarilumab) in Hospitalized COVID-19 Patients
TARRYTOWN, N.Y. and PARIS, April 27, 2020 /PRNewswire/ -- Independent Data Monitoring Committee recommended continuing ongoing Phase 3 trial only in the more
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":"TARRYTOWN, N.Y. and PARIS, April 27, 2020 /PRNewswire/ -- \nIndependent Data Monitoring Committee recommended continuing ongoing Phase 3 trial only in the more advanced \"critical\" group with Kevzara higher-dose versus placebo and discontinuing less advanced \"severe\" group\nPhase 3 trial will be amended to enroll only \"critical\" patients\nPhase 3 trial also be amended to discontinue lower-dose Kevzara (200 mg); all new patients to receive either higher-dose Kevzara (400 mg) or placebo\nNo new safety findings were observed for Kevzara use in COVID-19 patients\nRegeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced the preliminary results from the Phase 2 portion of an ongoing Phase 2/3 trial evaluating Kevzara® (sarilumab), an interleukin-6 (IL-6) receptor antibody, in hospitalized patients with \"severe\" or \"critical\" respiratory illness caused by COVID-19. Following a review by the Independent Data Monitoring Committee (IDMC) of all available Phase 2 and Phase 3 data, the trial will be immediately amended so that only \"critical\" patients continue to be enrolled to receive Kevzara 400 mg or placebo. \nThe randomized Phase 2 portion of the trial compared intravenously-administered Kevzara higher dose (400 mg), Kevzara lower dose (200 mg) and placebo. It assessed 457 hospitalized patients, who were categorized at baseline as having either \"severe\" illness (28% of patients), \"critical\" illness (49% of patients) or \"multi-system organ dysfunction\" (MSOD) (23% of patients). Patients were classified as \"severe\" if they required oxygen supplementation without mechanical or high-flow oxygenation; or \"critical\" if they required mechanical ventilation or high-flow oxygenation or required treatment in an intensive care unit. \nPreliminary analysis of the Phase 2 portion of the trial demonstrated that Kevzara rapidly lowered C-reactive protein (CRP), a key marker of inflammation, meeting the primary endpoint (see table below). Baseline levels of IL-6 were elevated across all treatment arms, with higher levels observed in \"critical\" patients compared to \"severe\" patients. Additionally, no new safety signals were observed with the use of Kevzara in COVID-19 patients.\nAnalysis of clinical outcomes in the Phase 2 trial was exploratory and pre-specified to focus on the \"severe\" and \"critical\" group...