Pfizer's Second Etrasimod Phase 3 Ulcerative Colitis Trial Hits Primary Goal

Pfizer Inc PFE has announced topline results from a second Phase 3 study of etrasimod for moderately to severely active ulcerative colitis (UC).
The 12- and 52-week ELEVATE UC 52 follow the recent announcement of 12-week findings from the ELEVATE UC 12 trial.
In this 52-week study, also known as ELEVATE UC 52, etrasimod patients achieved statistically significant improvements in the co-primary endpoints of clinical remission at weeks 12 and 52 compared to placebo.
Statistically significant improvements were attained in all key secondary endpoints at 12 and 52 weeks.
Related: Pfizer's Ulcerative Colitis Candidate Aces Late-Stage Study.
Etrasimod demonstrated a safety profile consistent with previous studies, including the Phase 2 OASIS trial.
Full results from the studies will be submitted for future scientific publication and presentation.
These data, along with results from ELEVATE UC 12 and the long-term extension from these two trials (ELEVATE UC OLE), are expected to form the basis for planned future regulatory filings. Pfizer expects to initiate regulatory filings later this year.
Price Action: PFE shares are up 0.86% at $53.74 during the market session on the last check Tuesday.