The global head of Development and External Affairs-Neuroscience at Janssen Pharmaceutical discussed the results of a phase 2 core and extension study of ponesimod in patients with relapsing-remitting multiple sclerosis.
"Today, which is 8 and a half years after we started this, there is still 197 patients on ponesimod 20-mg. To me, as a clinician, that talks to the long-term safety and tolerability of ponesimod very eloquently.”
Ponesimod (Janssen Pharmaceutical), a selective sphingosine 1-phosphase receptor-1 (S1P) modulator, has shown previous success in phase 3 studies, most notably in OPTIMUM (NCT02425644). A new phase 2b core study and its extension looked at the long-term effects of ponesimod in patients with relapsing-remitting multiple sclerosis (RRMS) across a median exposure of 8.02 years.
Data from the study presented at MS Virtual, the 8th Joint ECTRIMS-ACTRIMS meeting, September 11–13, 2020, showed that treatment with ponesimod 20-mg resulted in consistently low levels of disease activity across relevant clinical and magnetic resonance imaging (MRI) outcomes, including lowered annualized relapse rates (ARRs) and confirmed disability accumulation (CDA). To understand more about the results and the impact this study has, NeurologyLive spoke to Luc Truyen, MD, PhD.
Truyen, global head, Development and External Affairs-Neuroscience, Janssen Pharmacuetical, provided more context of the phase 2b study and its extension, as well as why the data is clinically meaningful.