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