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Regeneron and Sanofi Provide Update of P-II/III Adaptive-Designed Trial of Kevzara in Hospitalized Patients with COVID-19 in the US

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Regeneron and Sanofi Provide Update of P-II/III Adaptive-Designed Trial of Kevzara in Hospitalized Patients with COVID-19 in the US

Shots:

  • Following the IDMC recommendation- ongoing P-III study will be amended to enroll only critical patients. The P-III study also be amended discontinue lower-dose of Kevzara (200 mg) with all new patients to receive either Kevzara (400 mg) or placebo
  • The ongoing portion of P-III study will enroll ~600 patients in the critical group with its anticipated results in June. Additionally- Regeneron is advancing a targeted anti-SARS-CoV-2 Ab cocktail and plans to initiate the clinical study in Jun’2020
  •  The results of P-II study includes exploratory clinical endpoints for the "critical" group- which is the focus of ongoing P-III study. Additionally- the companies are conducting second P-III study assessing Kevzara in ~400 patients hospitalized with COVID-19- currently enrolling in Italy- Spain- Germany- France- Canada- Russia- Israel and Japan with anticipated results in Q3’20

Click here ­to­ read full press release/ article | Ref: Regeneron | Image: WSJ

Related news: Sanofi and Regeneron to Initiate the Clinical Program Evaluating Kevzara (sarilumab) in Patients with Severe COVID-19


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