Highlights from

ECCO 2019

European Crohn's and Colitis Organisation's 14th congress

Copenhagen 6-9 March 2019

Cyclosporine: novel low-dose, controlled-release formulation

Cyclosporine is effective in acute severe ulcerative colitis. However, concerns regarding systemic toxicities have limited its role to short-term induction therapy and as a bridge to other therapies. ST-0529 is a novel low-dose, controlled-release formulation of cyclosporine that was shown safe and well-tolerated in a phase 2a pilot study [1].

The phase 2a pilot study with 118 patients with mild or moderate ulcerative colitis, receiving 75 mg ST-0529 once daily, showed a numerically higher but not statistically significant difference in remission rate compared with placebo (13.2% vs 6.3%, P=0.22) after 4 weeks of treatment. Rates of clinical response were 30.2% and 18.8% (P=0.19). No differences were observed between the treatment groups for mucosal and histological healing. In the post hoc analysis, differences in the clinical response between treatment subgroups achieved statistical significance in some subgroups, with the largest clinical response rate seen in moderate ulcerative colitis patients taking 5-aminosalicylates and/or steroids. These preliminary data support further development of ST-0529 as a treatment for the induction and maintenance of remission in ulcerative colitis patients with moderate to severe disease.

Keywords: ulcerative colitis

  1. Bloom S, et al. ECCO 2019, OP16.

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