Positive results were announced from a phase 3 study evaluating etrasimod for the treatment of moderately to severely active ulcerative colitis (UC).
Etrasimod is an oral selective sphingosine 1-phosphate (S1P) receptor modulator currently being investigated to treat a range of immuno-inflammatory diseases.
The global phase 3, randomized, double-blind ELEVATE 12 trial (ClinicalTrials.gov Identifier: NCT03996369) evaluated the efficacy and safety of etrasimod 2mg once daily vs placebo in 354 patients with UC who had previously failed or were intolerant to at least 1 conventional, biologic, or Janus kinase (JAK) inhibitor therapy. The primary endpoint was clinical remission (assessed by Mayo component subscores) at week 12.
Results from the study showed that etrasimod was associated with statistically significant improvements in clinical remission at week 12 compared with placebo. Additionally, statistically significant improvements in all key secondary endpoints (endoscopic improvement, symptomatic remission, mucosal healing) were achieved. Etrasimod demonstrated a favorable safety profile consistent with previous phase 2 studies.
“These positive results demonstrate that etrasimod, if approved, could be a potential breakthrough option for patients with ulcerative colitis who aren’t able to experience improvement on current therapies,” said Michael Corbo, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development. “This outcome represents a continuation of our effort to develop new therapeutic approaches to treat immuno-inflammatory diseases and address the need for oral therapies for UC patients with inadequate response, loss of response, or intolerance to conventional or advanced therapies.”
Etrasimod is also being evaluated in the phase 3 ELEVATE UC 52 trial (ClinicalTrials.gov Identifier: NCT03945188) in patients with moderately to severely active UC. Results from the study are expected by the end of the first quarter 2022.
Pfizer announces positive top-line results for phase 3 trial of etrasimod in ulcerative colitis patients. News release. Pfizer Inc. March 23, 2022. https://www.businesswire.com/news/home/20220323005370/en/Pfizer-Announces-Positive-Top-Line-Results-for-Phase-3-Trial-of-Etrasimod-in-Ulcerative-Colitis-Patients