Global Phase 3 Trial of Oral Ponesimod Plus Tecfidera Enrolling Relapsing MS Patients
Actelion is recruiting about 600 relapsing multiple sclerosis (MS) patients to a Phase 3 trial testing the addition of oral ponesimod to Tecfidera (dimethyl fumarate) in people who continue experiencing relapses while on the treatment.
Ponesimod works in a similar way to Novartis’ Gilenya (fingolimod) — making immune cells accumulate in lymph nodes instead of entering the bloodstream. This reduces the number of immune cells entering the brain and spinal cord, and could potentially improve the impact of Tecfidera — a treatment developed by Biogen.
The aim of the trial is to explore whether the addition of ponesimod could harness lingering disease activity in Tecfidera-treated patients.
The trial, called POINT (NCT02907177), will run at 106 locations across North America and Europe. Patients, ages 18–55, with either relapsing-remitting MS or secondary progressive disease with relapses, are eligible to participate if they have been taking Tecfidera for at least six months before enrollment.
But only those who experienced a relapse or show signs of disease activity on a magnetic resonance imaging (MRI) scan within a year of enrollment will be able to take part. Disease activity needs to have emerged after at least three months of Tecfidera treatment.
There is also a range of exclusion criteria — for instance, another medical condition or earlier use of specific drugs may prevent patients from participating. To find out more, interested patients are encouraged to contact study investigators at each clinic. A list of locations, along with contact details, can be found on the trial’s registration website.
Enrolled patients will be randomly assigned to treatment with ponesimod in addition to their Tecfidera treatment or a placebo plus Tecfidera. Neither patients nor study staff will be aware of which treatment a patient receives.
Treatment will continue for at least 60 weeks, after which researchers will analyze the rate of relapses — the trial’s main outcome measure. In addition, researchers will analyze rates of disability progression, the potential impact of the treatment on brain volume, time to the first relapse, disease activity on MRI scans, and fatigue.
To determine if the combination is safe, scientists will also track adverse events — all negative outcomes in a trial — and assess if these events are linked to the treatment, the disease itself, or other factors.
Ponesimod, which prevents immune cells from leaving the lymph nodes through its actions on the S1P1 receptor on T- and B-cells, has been studied in relapsing-remitting MS in a Phase 2 trial (NCT01006265). The study showed that the treatment reduced MRI lesions and relapse rates in patients.
Actelion is also running a Phase 3 trial (NCT02425644) comparing ponesimod alone to another MS therapy, Aubagio (teriflunomide). This trial is fully enrolled and expected to conclude in May 2019. No results are available yet.