Results from the phase 3 OPTIMUM study, which evaluated the efficacy and safety of Ponesimod compared to Teriflunomide ( Aubagio ) in adults with relapsing multiple sclerosis were announced.
The study met its primary and most secondary endpoints.
Ponesimod is a selective sphingosine-1-phosphate receptor 1 ( S1P1 ) modulator, a class of drugs that is believed to functionally inhibit S1P activity and reduce the number of circulating lymphocytes by trapping them in the lymph nodes.
Therefore, there are less inflammatory cells available to cross into the central nervous system ( CNS ) where they could damage myelin.
Myelin is a protective sheath that insulates nerve cells and is damaged in patients with multiple sclerosis.
The primary endpoint of OPTIMUM was annualized relapse rate ( ARR ) up to the end of the study. A key secondary endpoint was change from baseline to week 108 in fatigue-related symptoms. Fatigue is considered a significant unmet need from patients’ perspective.
Additionally, the study evaluated other secondary endpoints: cumulative number of combined unique active lesions ( CUALs ) using magnetic resonance imaging ( MRI ), time to first 12-week confirmed disability accumulation ( CDA ) and time to first 24-week CDA from baseline to end of the study.
The safety profile observed for Ponesimod in the OPTIMUM study was consistent with previous studies of Ponesimod, and the known safety profile for other S1P receptor modulators.
OPTIMUM was a head-to-head, prospective, multicenter, randomized, double blind, active controlled, parallel-group, phase 3 superiority study to compare efficacy, safety and tolerability of Ponesimod 20 mg versus Teriflunomide 14 mg in adults with relapsing multiple sclerosis.
The study has included 1,133 participants with the treatment duration of 108 weeks.
Ponesimod prevents immune cells from crossing the bloodbrain barrier and damaging myelin. Myelin is a protective sheath that insulates nerve cells and is damaged in patients with multiple sclerosis. ( Xagena )
Source: Janssen Pharmaceutical, 2019