- The P-IIb LTS part A assesses tolebrutinib (5/15/30/60mg/day) in patients with RMS and in Part B, where all participants switched to the 60mg
- The study demonstrated a reduction in MS disease activity as MRI and showed a favorable 1yrs. tolerability. EDSS score (2.18 to 2.65), for 60/60mg treatment group, SD score (2.65 & 2.45); low MRI lesion activity in patients who started on or switched to 60mg. 98% of patients remained on treatment in P-IIb extension study @48wks.
- @48wks. of the extension study, low Gd-enhancing lesions (<0.4) in the 60/60mg arm. Additionally, data from in vitro studies in human microglia extended previous observations that BTK-dependent inflammatory signaling can be modulated by tolebrutinib
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