Data of InnoCare's Orelabrutinib for the Treatment of MS Released at 2025 ACTRIMS Forum

InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the phase II results of orelabrutinib for the treatment of relapsing-remitting multiple sclerosis (RRMS) was released at the 10th annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum, which will be also presented as the on-site poster on Feb. 27 U.S. Eastern Time.

The Forum is held from February 27 to March 1 in West Palm Beach, Florida of the United States. As a premier global event in neuroimmunology, ACTRIMS gathered scholars and experts specializing in neuroimmunology from around the world to jointly explore the cutting-edge developments in multiple sclerosis and related disorders.

Poster Presentation (Poster No.: P094)

Positive Phase 2 Results of Orelabrutinib in Patients with Relapsing-Remitting Multiple Sclerosis

Orelabrutinib was shown to be highly effective for the treatment of relapsing-remitting multiple sclerosis (RRMS) patients. The 80 mg once daily (QD) dose showed the best efficacy and safety profile, thus being selected for phase III progressive MS studies.

In this double-blind, phase II trial, 158 eligible RRMS subjects were randomized in a 1:1:1:1 ratio to one of four treatment groups: placebo, orelabrutinib 50 mg QD, orelabrutinib 80 mg QD, and orelabrutinib 50 mg twice daily (BID). The subjects in the placebo group were switched to orelabrutinib 50 mg QD at Week 13. The primary endpoint was the cumulative number of new gadolinium‐enhancing (Gd+) T1 brain lesions at Week 12 (based on Gd+ T1 lesions at Weeks 4, 8, and 12) compared to placebo.

At Week 12, all three treatment groups showed statistically significant reductions in the cumulative number of new Gd+ T1 lesions and new/enlarging T2 lesions compared to the placebo group (p < 0.05), while the 80 mg QD and 50 mg BID groups showed statistically significant reductions throughout 24 weeks compared to the placebo/50 mg QD group (p < 0.05). The 80 mg QD group demonstrated the highest reductions of 90.4% at Week 12 compared to placebo and 92.3% at Week 24 compared to the placebo/50 mg QD group. The new lesion control by each orelabrutinib group occurred at the earliest assessment timepoint of 4 weeks and was sustained throughout 24 weeks.  

BTK regulates the functions of B cells and myeloid cells, which are implicated in the pathogenesis of MS. Orelabrutinib is a highly selective, brain-penetrant BTK inhibitor that not only inhibits B cell and macrophage activation peripherally, but also inhibits B cell, microglia, and macrophage activation in the central nervous system.

For more detailed clinical data, please refer to ACTRIMS website.

About InnoCare

InnoCare (HKEX: 09969; SSE: 688428) is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and United States.