Evobrutinib—A First-in-Class Drug—Shows Efficacy in Phase 2 Clinical Trials

 

October 12, 2018—At the European Committee on Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting in Berlin, German October 10-12, results from a double-blind placebo-controlled trial (NCT02975349) for the use of evobrutinib (M2951; EMD Serono, Rockland, MA) to treat patients with relapsing multiple sclerosis (MS) were presented.

Adult patients (n = 267) with relapsing or secondarily progressive MS with relapses who were treated with 75 mg evobrutinib once or twice daily had reductions in their number of T1 gadolinium-enhancing and T2 lesions (Table).Significant reductions in the lesion rate ratio (RR) were observed in patients treated with evobrutinib 75 mg daily (RR = .30, = .0015) and 75 mg twice daily (RR = 0.44, = .0313), but not in those treated with 25 mg daily (RR = 1.45, P= .295). A trend test showed evidence of a dose-response relationship (= .0011). Although not statistically significant, a trend of decreasing annualized relapse rate (ARR) was observed in patients given evobrutinib 75 mg daily (ARR = .13, P = .09) and 75 mg twice daily (ARR = .08, P = .06) compared to placebo (ARR = .37) that had evidence of a dose-response relationship (trend test = .01). 

 

Table. Number of T1 gadolinium-enhancing (Gd+) and T2 lesions.

 

Mean total T1 Gd+ lesions weeks 12-24

Standard deviation

Mean total T2 lesions weeks 12-24

Standard deviation

Placebo

3.85 

5.44

5.96

6.99

25 mg evobrutinib daily

4.06

8.02

6.52

11.57

75 mg evobrutinib daily

1.69

4.69

3.41

10.75

75 mg evobrutinib twice daily

1.15

3.70

2.19

4.72

Although overall treatment-related adverse events were comparable across all groups, serious adverse events were higher in those treated with evobrutinib 75 mg twice daily, primarily driven by elevated liver enzymes, which were asymptomatic and reversible.

Fernando Dangond, MD, Therapeutic Area Head, Global Clinical Development, Neurology and Executive Medical Director at EMD Serono said, “The significant decrease in the number of lesions on MRI and the trend of decreasing ARR for patients treated with evobrutinib warrants further study in larger clinical trials. Additionally, the novel dual mechanism of targeting B cells and macrophages (shifting from a proinflammatory to an anti-inflammatory phenotype) suggests it may be of benefit for patients with other autoimmune diseases (eg, rheumatoid arthritis or systemic lupus erythematosus), and we are conducting trials in those areas as well.”

 

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