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Orelabrutinib is a highly selective, potent oral BTK inhibitor.
Pharmaceutical Company: Biogen-InnoCare
Route and Dose of Administration: Oral (once daily)
Emerging Treatment for: Relapsing-remitting multiple sclerosis
Status: In Phase II clinical trial
Orelabrutinib selectively inhibits the protein, Bruton’s tyrosine kinase or BTK, to reduce the activation of B cells that contribute to brain and spinal cord inflammation in MS.
Phase II trial
Phase II Trial – A Phase 2 Study of Orelabrutinib in Patients with Relapsing-Remitting Multiple Sclerosis
This is a randomized, double-blind, placebo-controlled phase 2 trial and will be followed by an extension study. In the core study, participants with relapsing-remitting MS will be randomized to one of four treatment groups: low-dose, medium-dose, high dose of orelabritinib, and placebo. Primary outcome measures will evaluate the efficacy of orelabrutinib on new gadolinium-enhancing brain lesions compared to placebo over a 12-week treatment period. The safety and tolerability of orelabrutinib will also be assessed. Participant recruitment is ongoing. The anticipated study completion date is March 2024.