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Phase 2 trial associates ritlecitinib and brepocitinib with improved efficacy outcomes compared with placebo in patients with moderate to severe ulcerative colitis.

The investigational, oral, selective sphingosine-1-phosphate-1 (S1P) receptor modulator VTX002 was associated with increased clinical, endoscopic, and histologic remission rates compared with placebo in patients with moderately to severely active ulcerative colitis (UC), in a phase 2 study. Moreover, the agent was well tolerated in this study population.

In a multicentre, randomized, double-blind phase 2 trial (NCT05156125), Bruce Sands, MD, and colleagues tested VTX002 in patients with moderately to severely active UC (n=213).¹ The study authors randomized participants 1:1:1 to 60 mg VTX002, once daily, 30 mg VTX002, once daily, or a placebo. The primary endpoint was clinical remission at week 13.

In the 60 mg and 30 mg VTX002 arms, 27.9% and 23.9% of the participants achieved clinical remission by week 13, respectively; in the placebo arm, 11.4% achieved this endpoint. These findings significantly favored the experimental arms over the placebo arm (P=0.018; P=0.041). Notably, the effect appeared to be present regardless of experience with advanced therapies. Secondary efficacy endpoints, such as endoscopic improvement (36.8%; 32.4%; 15.7%), histologic remission (19.1%; 28.2%; 7.1%), and symptomatic remission (42.6%; 40.8%; 25.7%) all favored the experimental arms over the placebo arm.

“The novel agent was generally well tolerated,” stated Dr. Sands. The rate of AEs was somewhat higher in the experimental arms than in the placebo arm (47% vs 34.3%), but the rate of serious AEs was low, with 2.7% and 4.3% in the 60 mg arm and 30 mg arm, respectively. “Finally, there were no cases of bradycardia, atrioventricular block, serious infections, macular edema, or death,” Dr. Sands noted.

In conclusion, VTX002 was associated with improved health outcomes compared with placebo and had an acceptable safety profile in patients with moderately to severely active UC.

Medical writing support was provided by Robert van den Heuvel.
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