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J&J's ponesimod meets primary and secondary endpoints at Phase 3 in relapsing multiple sclerosis

Published on 26/07/19 at 11:42am

New Phase 3 data has been released on Johnson & Johnson’s selective sphingosine-1-phosphate receptor 1 (S1P1) modulator ponesimod, reporting that the drug performed favourably compared to Genzyme’s Aubagio (teriflunomide) in the treatment of adult patients with relapsing multiple sclerosis.

While J&J noted that the data was “positive”, in-depth details on the efficacy of the therapy were not forthcoming. However, it was confirmed that, in 1,133 participants over 108 weeks of treatment, ponesimod met its primary endpoint of annualised relapse rate (ARR) up to the end of the study.

Additionally, it was found that the therapy met its secondary endpoint of change from baseline in fatigue-related symptoms – an achievement of particular note as fatigue is an area of unment need in this indication, as reported by patients.

The trial also showed that ponesimod met a number of additional secondary endpoints, including 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.

J&J confirmed that the data will be submitted to both the FDA and EMA in support of new drug applications.   

Matt Fellows

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