Pfizer’s Ulcerative Colitis Drug Helps Patients in Phase 3 Study

Pfizer recently announced that its selective sphingosine 1-phosphate (S1P) receptor modulator to treat moderate to severely active ulcerative colitis (UC) significantly improved the primary endpoint of clinical remission at week 12 compared to placebo.  

The global Phase 3 randomized clinical trial, ELEVATE 12, enrolled 354 UC patients who previously failed or were intolerant to at least one conventional, biologic, or JAK therapy. All patients received 2 milligrams of etrasimod once daily.  

Patients saw statistically significant improvements in all key secondary endpoints in the trial, and the safety profile was consistent with the previous Phase 2 study.  

The randomized Phase 2 study enrolled moderate to severe UC patients. Most patients who achieved clinical response, clinical remission, or endoscopic improvements at week 12 sustained or improved effects up to week 46. Etrasimod also demonstrated a favorable benefit/risk profile.  

“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,” Michael Corbo, chief development officer, inflammation and immunology at Pfizer, said in the announcement.  

“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,” Corbo continued.  

Pfizer will announce full study results for future publication and presentation shortly. These data, along with results from ELEVATE 52, are expected to form the basis for planned future regulatory filings. Results from the ELEVATE 52 trial will become available later this year.  

UC is a chronic and often debilitating inflammatory bowel disease that affects nearly 750,000 Americans.   

In December 2021, Pfizer entered into a $6.7 billion proposed pharma acquisition deal with Arena Pharmaceuticals to develop therapies for chronic disease management.  

Arena Pharmaceutical’s portfolio includes diverse development-stage therapeutic candidates in gastroenterology, dermatology, and cardiology, including etrasimod. So far, the company has built a robust development program for etrasimod, including two Phase 3 studies in ulcerative colitis (UC). 

Researchers evaluated the efficacy and safety of etrasimod in moderate to severe UC patients over 12 weeks versus placebo. Most patients who achieved clinical response, clinical remission, or endoscopic improvement at week 12 saw sustained or improved effects up to week 46 with 2 milligrams of etrasimod in the open-label extension.