Selective oral sphingosine 1-phosphate receptor modulator amiselimod

Amiselimod (AMS) is a new selective oral sphingosine 1-phosphate (S1P) receptor modulator, which is being developed for the treatment of various autoimmune-mediated diseases, including Crohn’s disease. In a prospective, randomised, placebo-controlled clinical trial, treatment of refractory Crohn’s disease with AMS 0.4 mg for 12 weeks was generally well-tolerated, without any new safety signals [1]. No effect was found on clinical or biochemical disease activity.

Of 78 randomised patients, 28/40 patients on AMS and 33/38 on placebo completed the 14-week induction trial. The primary endpoint Crohn's Disease Activity Index (CDAI)100 was attained in 19/39 (48.7%) on AMS and in 20/37 (54.1%) on placebo. CDAI 70 and clinical remission (CDAI <150) were observed in 21/39 (53.8%) and 11/39 (28.2%) on AMS and in 24/37 (64.9%) and 15/37 (40.5%) on placebo, respectively. No clinically meaningful differences were observed in serum C-reactive protein concentrations and faecal calprotectin in either group. Mean lymphocyte counts on AMS showed a significant reduction by week 4 (47.7% of baseline), after which they reached a graphical plateau. The authors considered the high placebo response and weaker lymphocyte reduction to contribute to the negative efficacy results in this study.

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   1. D’Haens G, et al. ECCO 2019, DOP48.

Posted on 9 May, 20198 April, 2024