The P-II trial results presented at CMSC 2023 evaluating high or low doses of frexalimab vs PBO in a ratio (4:4:1:1) in 129 patients for 12wks. Patients receiving PBO shifted to frexalimab after 12wk. & entered in an ongoing open-label part B
The trial met its 1EPs & showed that high & low-dose frexalimab patients achieved a reduction in no. of new GdE T1-lesions (89% & 79%) @12wk. & in new or enlarging T2-lesions & total GdE T1-lesions, patients were free of new GdE T1-lesions in high-dose (96%) @24wk. along with reduced disease activity
Early effects on MSIS-29 physical impact score (PROs) & plasma NfL level will also report, 97% completed part A & continued to the open-label part B. The company also plans to initiate pivotal trials in MS in early 2024
Ref: Sanofi | Image: Sanofi
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