INNOCARE (09969): The phase II clinical data of ocrelizumab for the treatment of relapsing-remitting multiple sclerosis will be presented in an abstract and poster display at the 2025 ACTRIMS conference.

INNOCARE (09969) announced that the phase II trial results of Aubiterion for the treatment of relapsing-remitting multiple sclerosis have been released at the 10th Annual Meeting of the American Committee for the Treatment and Research of Multiple Sclerosis (ACTRIMS). This forum is a top event in the field of global neuroimmunology, aiming to explore the cutting-edge developments in multiple sclerosis and related diseases. The results will also be presented in the form of a live poster (poster number: P094) on February 27th, Eastern Time. The study results indicate that Aubiterion demonstrated high effectiveness in treating patients with relapsing-remitting multiple sclerosis. The dose of 80 mg Aubiterion once a day showed the best efficacy and safety, and will be used as the dose for the phase III clinical trial of Aubiterion in the treatment of progressive multiple sclerosis. In the double-blind phase II clinical trial, 158 eligible participants with relapsing-remitting multiple sclerosis were randomly assigned to four treatment groups in a ratio of 1:1:1:1: placebo group, daily 50 mg Aubiterion dose group, daily 80 mg Aubiterion dose group, and daily 50 mg Aubiterion dose group twice a day. Participants in the placebo group switched to daily 50 mg Aubiterion at week 13. The primary endpoint was the comparison of the cumulative number of new Gd-enhanced (Gd+) T1 brain lesions at week 12 (based on Gd+T1 new lesions at weeks 4, 8, and 12) compared to the placebo group. At week 12, all three dose groups taking Aubiterion showed a significant reduction in both Gd+T1 cumulative new lesions and T2 cumulative new/enlarging lesions compared to the placebo group (p<0.05), while the daily 80 mg dose group and daily 50 mg dose group twice a day showed a significant reduction in the cumulative number of these lesions within 24 weeks compared to the placebo group/daily 50 mg dose group (p<0.05). The daily 80 mg dose group showed the highest reduction of 90.4% compared to the placebo group at week 12, and the highest reduction of 92.3% compared to the placebo group/daily 50 mg dose group at week 24. Each dose group of Aubiterion achieved control of new lesions at the earliest assessment point at week 4, and the efficacy continued until week 24. BTK plays an important role in regulating the function of B cells and bone marrow cells, which is related to the pathogenesis of multiple sclerosis. Aubiterion is a highly selective, brain-penetrating BTK inhibitor that not only inhibits the activation of peripheral B cells and macrophages, but also inhibits the activation of central nervous system B cells, microglial cells, and macrophages.