April 27, 2020 / 11:15 AM / a month ago

BRIEF-Regeneron And Sanofi Provide Update On U.S. Phase 2/3 Adaptive-Designed Trial Of Kevzara® In Hospitalized COVID-19 Patients

April 27 (Reuters) - Regeneron Pharmaceuticals Inc:

* REGENERON AND SANOFI PROVIDE UPDATE ON U.S. PHASE 2/3 ADAPTIVE-DESIGNED TRIAL OF KEVZARA® (SARILUMAB) IN HOSPITALIZED COVID-19 PATIENTS

* REGENERON PHARMACEUTICALS - NO NEW SAFETY FINDINGS WERE OBSERVED FOR KEVZARA USE IN COVID-19 PATIENTS

* REGENERON - IDMC RECOMMENDED CONTINUING ONGOING PHASE 3 TRIAL ONLY IN MORE ADVANCED “CRITICAL” GROUP WITH KEVZARA HIGHER-DOSE VERSUS PLACEBO

* REGENERON - PRELIMINARY ANALYSIS OF PHASE 2 PORTION OF TRIAL DEMONSTRATED THAT KEVZARA RAPIDLY LOWERED C-REACTIVE PROTEIN MEETING PRIMARY ENDPOINT

* REGENERON - INDEPENDENT DATA MONITORING COMMITTEE RECOMMENDED DISCONTINUING LESS ADVANCED “SEVERE” GROUP FOR KEVZARA TRIAL IN COVID-19 PATIENTS

* REGENERON PHARMACEUTICALS - RAPIDLY ADVANCING TARGETED ANTI-SARS-COV-2 ANTIBODY COCKTAIL AND PLAN TO INITIATE CLINICAL TRIALS IN JUNE

* REGENERON PHARMACEUTICALS - PHASE 3 TRIAL WILL BE AMENDED TO ENROLL ONLY “CRITICAL” PATIENTS

* REGENERON - PHASE 3 TRIAL AMENDED TO DISCONTINUE LOWER-DOSE KEVZARA (200 MG); ALL NEW PATIENTS TO GET EITHER HIGHER-DOSE KEVZARA (400 MG) OR PLACEBO

* REGENERON PHARMACEUTICALS INC - COMPANIES ARE ALSO CONDUCTING A SECOND TRIAL IN COUNTRIES OUTSIDE OF U.S.

* REGENERON PHARMACEUTICALS - THE COMPANIES ARE ALSO CONDUCTING A SECOND TRIAL IN COUNTRIES OUTSIDE OF U.S.

* REGENERON PHARMACEUTICALS INC - INITIAL RESULTS FROM THE SECOND TRIAL ARE EXPECTED IN Q3 OF 2020

* REGENERON - IN PRELIMINARY PHASE 2 ANALYSIS, KEVZARA HAD NO NOTABLE BENEFIT ON CLINICAL OUTCOMES WHEN COMBINING “SEVERE” & “CRITICAL” GROUPS, VERSUS PLACEBO

* REGENERON-IN PRELIMINARY PHASE 2 ANALYSIS, KEVZARA HAD NO NOTABLE BENEFIT ON CLINICAL OUTCOMES WHEN COMBINING “SEVERE” & “CRITICAL” GROUPS, VERSUS PLACEBO Source text for Eikon: Further company coverage:

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