Regeneron-Sanofi announce 1st patient for clinical study outside U.S.
Category: #health  By Saipriya Iyer  Date: 2020-04-01
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Regeneron-Sanofi announce 1st patient for clinical study outside U.S.

Regeneron Pharmaceuticals, Inc. & Sanofi have recently announced the 1st patient to be treated in the COVID-19 clinical program, outside of the United States. The study, which is anticipated to enroll nearly 300 patients, will evaluate the efficacy and safety of Kevzara® (sarilumab), with a single intravenous dose added to supportive care, among patients severely infected by COVID-19.

The clinical program has currently been initiated in countries affected by the coronavirus namely the U.S., Russia, Canada, France, Germany, Spain, and Italy. It is the 2nd double blind, multi-center, Phase 2/3 trial that was conducted as a part of the Kevzara COVID-19 program. The two companies are continuously working with health authorities across the globe to further initiate the program at additional sites.

Kevzara is a fully human monoclonal antibody that hinders the pathway of interleukin-6 (IL-6) by blocking and binding the IL-6 receptor. A single-arm study conducted in China has offered the preliminary data for the role of IL-6. Scientists have primary evidence on the capability of IL-6 in driving the inflammatory immune response, which leads to ARDS (acute respiratory distress syndrome) among COVID-19 patients. However, within days of receiving tocilizumab (another IL-6 receptor antibody) in a preliminary non-peer-reviewed study in China, a 21-patient cohort experienced reduced fever & lower need for supplementary oxygen.

Regeneron’s Co-founder, Chief Scientific Officer and President, George D. Yancopoulos, M.D., Ph.D., has stated that the company has been consistently conducting the global trial program to examine the true impact of Kevzara against overactive inflammatory response in COVID-19 patients’ lungs. Additionally, it has been continuously advancing the novel antibody cocktail to treat and prevent the deadly disease rapidly.

Sanofi’s Global Head of Research & Development, John Reed, M.D., Ph.D., has also stated that the company, along with Regeneron have been initiating trials to determine the potential of Kevzara in addressing the ongoing global COVID-19 crisis. These clinical trials will favorably support the company’s effort to produce a vaccine for COVID-19 disease as well as provide other drugs to treat impacted patients.

Source credit:

https://www.prnewswire.com/news-releases/first-patient-outside-us-treated-in-global-kevzara-sarilumab-clinical-trial-program-for-patients-with-severe-covid-19-301031444.html



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Saipriya Iyer

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Saipriya Iyer

Saipriya Iyer develops content for Market Size Forecasters, Algosonline, and myriad other platforms. A computer engineer by profession, she ventured into the field of writing for the love of playing with words. Having had a previous experience of 3 years under her bel...

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