Tamuzimod delivers promising long-term data in ulcerative colitis

Tamuzimod was associated with improved clinical, endoscopic, and histologic outcomes compared with placebo in patients with moderately to severely active ulcerative colitis (UC) at week 52 of a phase 2 study. Moreover, the drug had a favourable safety profile.

The selective S1PR1 modulator tamuzimod displayed encouraging efficacy and safety data as induction therapy for patients with UC [1]. Prof. Silvio Danese (Vito-Salute San Raffaele University, Italy) presented the long-term extension data of the phase 2 study evaluating tamuzimod. The randomised, double-blind controlled study (NCT05156125) allocated participants with moderately to severely active UC (n=213) 1:1:1 to tamuzimod 60 mg, tamuzimod 30 mg, or a placebo. After 13 weeks, participants with a clinical response (n=95) were eligible for maintenance therapy with the previously assigned treatment. Also, participants on placebo who lost response during the long-term extension were allowed to switch to the open-label extension phase, in which they received 60 mg tamuzimod. “All efficacy outcomes were based on non-responder imputation,” mentioned Prof. Danese.

At week 52, the clinical remission rates were 50.0% in both tamuzimod arms and 18.2% in the placebo arm (P=0.021; P=0.0078). Endoscopic remission was documented in 46.4% of participants in the 60 mg arm, 43.8% of the participants in the 30 mg arm, and 18.2% of participants in the placebo arm (P=0.076; P=0.032). In addition, endoscopic and histologic remission was observed in 25.0%, 37.5%, and 9.1% of participants in the 60 mg, 30 mg, and placebo arms, respectively (P=0.18; P=0.019). “The drug was very safe and there were no major adverse events,” according to Prof. Danese. “This is probably due to the high selectivity of tamuzimod,” he argued.

“Maintenance treatment with either 30 mg or 60 mg tamuzimod was efficacious and well-tolerated for up to 52 weeks, supporting the continued development of tamuzimod as a treatment for patients with UC,” concluded Prof. Danese.

1. 
   
   1. Sands BE, et al. Gastroenterology. 2024;166:S-240.
   2. Danese S, et al. Efficacy and safety of tamuzimod in moderately to severely active ulcerative colitis through 52 weeks: phase 2 long-term extension data. LB14, UEG Week 2024, 12–15 October, Vienna, Austria.

Medical writing support was provided by Robert van den Heuvel.
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Posted on 16 October 2024