Pfizer inflammatory disease drug hits goal in second study

Published March 29, 2022

Ned Pagliarulo Lead Editor

Jeenah Moon via Getty Images

Dive Brief:

• An experimental inflammatory disease drug acquired by Pfizer earlier this year met all of its goals in the second of two late-stage trials testing its potential in treating ulcerative colitis, a chronic bowel disease that affects millions of people in the U.S. and Europe. 
• Treatment with the drug, called etrasimod, led to statistically significant improvements in clinical remission rates at three months and at one year, Pfizer said in a March 29 statement. No specific data were disclosed; the company plans to present full results at a future medical meeting. 
• News of the study results come a week after Pfizer announced positive results from another late-stage study of etrasimod in ulcerative colitis. The two studies, along with data from open-label extension phases of the trials, will support applications for regulatory approval, which Pfizer said it intends to begin submitting later this year. 

Dive Insight:

Etrasimod was the main attraction for Pfizer in its recent deal to acquire Arena Pharmaceuticals for $7 billion. The drug works in a similar fashion as Bristol Myers Squibb’s medicine Zeposia, which was initially approved in 2020 for multiple sclerosis and has since been cleared for use in ulcerative colitis.

In pitching the Arena buyout to investors, Pfizer executives described etrasimod as potentially superior, although the drugs have not been studied against each other. They also noted etrasimod’s fit with the company’s existing inflammation drug business, which is currently led by the medicine Xeljanz.

The two Phase 3 studies testing etrasimod in ulcerative colitis were the first major tests of those ambitions. With no detailed data disclosed by Pfizer, however, it’s unclear how well etrasimod performed, although in a statement Pfizer’s head of inflammation and immunology development, Michael Corbo, reiterated the company’s expectation it could be “best in class.” 

The second study, which Pfizer read out Tuesday and is known as ELEVATE UC 52, tested etrasimod against a placebo in 433 people with moderately to severely active ulcerative colitis and who were either intolerant to or unsuccessfully treated with at least one other drug. 

Whereas the first trial only looked at the drug over 12 weeks, ELEVATE UC 52 measured the proportion of patients who achieved clinical remission at both 12 and 52 weeks. Results showed etrasimod outperformed placebo at both timepoints, Pfizer said. Safety results “were consistent” with prior testing. 

All of the study’s main secondary goals were also met, according to the company. 

In addition to ulcerative colitis, Pfizer plans on studying etrasimod in atopic dermatitis, Crohn’s disease, a type of esophageal inflammation and in alopecia areata. Should development succeed, etrasimod could potentially blunt the impact of Xeljanz losing patent protection, which Pfizer expects to occur in 2025.