Tolebrutinib Clinical Trials & Data - Sanofi initiated four Phase 3 trials of tolebrutinib across the full spectrum of MS and a Phase 3 study in Myasthenia Gravis[10] - At 18 months, 85% of patients remained relapse-free while on tolebrutinib 60mg[72] - In the long-term extension study, 94% of RMS patients remained on tolebrutinib as of September 6, 2021[81] - Tolebrutinib shows a strong impact on reducing new Gd-enhancing lesions in MS patients[69, 81] Neurology Pipeline Overview - Sanofi is developing SAR441344 (anti-CD40L mAb) which is in Phase 2 study for relapsing MS[10] - SAR445088 (anti-serine C1s mAb) is in Phase 2 study for CIDP[10] - SAR443820 (RIPK1i) completed Phase 1 study in ALS and has FDA Fast Track Designation[10] - ABL301, a bispecific antibody for Parkinson's disease, is in preclinical development through a collaboration with ABL Bio[23, 28] Tolebrutinib Pharmacology - Tolebrutinib inhibits BTK 64x faster than evobrutinib and 1,780x faster than fenebrutinib[87] - Tolebrutinib demonstrated intrinsically superior brain penetrance in non-human primates compared to evobrutinib and fenebrutinib, with a Kp,uu,CSF of 0397[94] - Tolebrutinib was 50x more potent in BTK inhibition than evobrutinib and 93x more potent than fenebrutinib[98]
Sanofi (SNY) Presents At ACTRIMS Forum 2022