Sanofi and Regeneron Pharmaceuticals, Inc. recently published 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.
The randomized Phase 2 portion of the trial compared intravenously-administered Kevzara higher dose (400 mg), Kevzara lower dose (200 mg), and placebo. 457 patients were assessed, with a preliminary analysis of the Phase 2 portion of the trial showing that Kevzara rapidly lowered C-reactive protein, a key marker of inflammation. However, no new safety findings were observed with the use of Kevzara in COVID-19 patients.
“Even in a pandemic setting, it’s both crucial and possible to obtain controlled data in adequately-sized trials to provide the evidence needed to inform optimal medical care,” said George D. Yancopoulos, M.D., Ph.D., Regeneron Co-Founder, President, and Chief Scientific Officer. “Emerging evidence with Kevzara and other repurposed drugs in the COVID-19 crisis highlight the challenges of making decisions about existing medicines for new viral threats using small, uncontrolled studies. We await results of the ongoing Phase 3 trial to learn more about COVID-19 and better understand whether some patients may benefit from Kevzara treatment. In addition, there is an acute need for tailored approaches that specifically target this virus. To that end, Regeneron is rapidly advancing our targeted anti-SARS-CoV-2 antibody cocktail and we plan to initiate clinical trials in June.”
“At Sanofi, we are committed to helping combat the global COVID-19 pandemic. As we quickly follow the science to better understand this disease and explore how best to treat patients, these initial results from the randomized clinical trial setting provide physicians much-needed insights and information regarding Kevzara for patients with COVID-19,” said John Reed, M.D., Ph.D., Sanofi’s Global Head of Research and Development. “While our evaluation of the use of Kevzara for COVID-19 treatment remains an investigational approach, Sanofi continues to stay at the forefront of multiple initiatives to fight this disease, including researching other potential treatment options, developing vaccine candidates that can be manufactured at large-scale, and potential collaboration for an innovative SARS-CoV-2 smartphone-based self-testing solution.”
The ongoing portion of the Phase 3 trial currently includes over 600 patients in the “critical” group. Regeneron and Sanofi have remained blinded to the ongoing portion of the Phase 3 trial and expect to report results by June.
Sanofi and Regeneron are also conducting a second trial in countries outside the United States, as approximately 400 patients hospitalized with COVID-19 infection across Italy, Spain, Germany, France, Canada, Russia, Israel, and Japan are currently enrolling in the Phase 3 trial of Kevzara.
The use of Kevzara for the treatment of the symptoms of the coronavirus is investigational and has not been fully evaluated by any regulatory authority.
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