Pfizer (NYSE:PFE) has announced that the Phase 3 ELEVATE 12 study of etrasimod met primary and key secondary endpoints.
The primary endpoint in the trial involved clinical remission in patients with severely active ulcerative colitis (UC) at week 12.
Etrasimod is an experimental once-daily selective sphingosine 1-phosphate (S1P) receptor modulator similar to Bristol-Myers Squibb’s Zeposia (ozanimod). Zeposia is now FDA approved for relapsing forms of multiple sclerosis and moderately to severely active ulcerative colitis.
The drug’s safety profile was in line with Phase 2 trials.
“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 and immunology of Pfizer Global Product Development.
The placebo-controlled ELEVATE 12 study enrolled 354 UC patients who had failed or could not tolerate at least one conventional, biologic or JAK therapy.
Pfizer picked up etrasimod via its recently completed $6.7 billion acquisition of Arena Pharmaceuticals.
Pfizer has an ongoing 12-month confirmatory trial for etrasimod known as ELEVATE 52.