Aubagio, by Sanofi, is an approved first-line therapy for MS. Like ponesimod, it works by reducing the activity of the immune system, albeit through different mechanisms.
Topline results from OPTIMUM showed that the annualized relapse rate (ARR) was significantly reduced by 30.5% with ponesimod, as compared to Aubagio, treatment — on average, 0.202 relapses per year in the ponesimod group and 0.290 among those given Aubagio.
A significant reduction (56%) in the number of new active, inflammatory brain lesions visible on a magnetic resonance imaging (MRI) scan was also seen with ponesimod treatment, as compared to Aubagio. There was also a trend towards lesser disability progression with ponesimod, but this did not reach statistical significance.
Ponesimod did lead to a statistically significant reduction in reported fatigue relative to Aubagio.
“Fatigue remains a challenging, yet invisible, symptom among those living with MS. We are encouraged by the results ponesimod shows in alleviating this symptom, as well as the reduction in new inflammatory lesions and disability accumulation,” Husseini Manji, MD, FRCPC, the Global Therapeutic Area head for Neuroscience at Janssen Research & Development, said in a press release.
“We look forward to collaborating closely with the EMA as the application process progresses,” Manji added.
Ponesimod’s safety was consistent with the that reported in previous trials, and with the known safety profile of other S1P receptor modulators.
“More than 2.3 million people worldwide live with MS — including 700,000 in Europe alone — and of this population, approximately 85 percent are initially diagnosed with relapsing MS. This submission is an important milestone as we work to bring a new treatment option to those living with relapsing forms of MS,” Mathai Mammen, MD, PhD, the global head of Janssen Research & Development, concluded.
Marisa holds an MS in Cellular and Molecular Pathology from the University of Pittsburgh, where she studied novel genetic drivers of ovarian cancer. She specializes in cancer biology, immunology, and genetics. Marisa began working with BioNews in 2018, and has written about science and health for SelfHacked and the Genetics Society of America. She also writes/composes musicals and coaches the University of Pittsburgh fencing club.