Pfizer’s S1P Modulator Drug Helps Ulcerative Colitis Patients

Pfizer recently announced positive top-line results from a second Phase 3 study of its selective sphingosine 1-phosphate (S1P) receptor modulator, etrasimod, to treat moderately to severely active ulcerative colitis (UC).  

The global Phase 3 ELEVATE UC 52 trial enrolled 433 UC patients who previously failed or were intolerant to at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy. Participants received two milligrams of etrasimod or a placebo once daily. 

In the trial, patients achieved statistically significant improvements in the co-primary endpoints of clinical remission at weeks 12 and 52 compared to placebo. Patients were eligible to continue with their randomized treatment independent of whether they reached the objective clinical response criteria at week 12.  

Pfizer will publish full ELEVATE UC 52 trial results in the near future. These data, results from ELEVATE UC 12, and the long-term extension from these two trials will form the basis for planned future regulatory filings.   

Notably, etrasimod demonstrated a safety profile consistent with previous studies, including the Phase 2 OASIS trial. In the OASIS trial, most patients who achieved clinical response, clinical remission, or endoscopic improvement at week 12 saw sustained or improved effects up to week 46 with two milligrams of etrasimod in the open-label extension. 

“For patients suffering with moderate to severe ulcerative colitis, these most recent data further demonstrate the substantial potential benefits of this medicine and clearly confirm its ability to achieve significant induction of remission at 12 weeks and now clinical remission at week 52,” Michael Corbo, chief development officer of inflammation and immunology at Pfizer, said in the announcement..  

“These data underscore etrasimod’s potential, if approved, as a best-in-class therapy. Etrasimod can potentially provide a new, once-daily, oral option with a rapid onset of action and without first dose titration,” Corbo continued.  

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

Arena Pharmaceutical’s portfolio includes diverse development-stage therapeutic candidates in gastroenterology, dermatology, and cardiology, including etrasimod. The drug is currently in development for various immuno-inflammatory diseases, such as gastrointestinal and dermatological diseases.