- Pfizer Inc (NYSE: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.
