Pfizer announced positive Phase 3 results for etrasimod in moderately to severely active ulcerative colitis patients
The study met the primary endpoint of the ELEVATE 12 study showing statistically significant improvement in clinical remission at week 12 with etrasimod (2 mg OD) vs placebo
Statistically significant improvements were achieved in all secondary endpoints and safety profile was said to be consistent with the previous Phase 2 trial
The trial enrolled 354 UC patients who had previously failed or were intolerant to at least one conventional, biologic, or JAK therapy
The complete Phase 3 data is not released and will be submitted for future scientific publication and presentations
These data along with results from ELEVATE 52 (to be announced in Q1 2022) are expected to form the basis for planned future regulatory filings
Pfizer’s Chief Development Officer, I&I mentioned, “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.”
Implication for Amgen:
Etrasimod (an oral NME competitor to anti-TNFs) has the advantage of oral convenience over anti-TNFs in UC. It is expected to have a low-moderate impact on STELARA and its biosimilars (additional clarity on impact will be known once full pivotal trial results are available). A Phase 2 trial for etrasimod in adolescent UC patients is currently ongoing.
Source: Press release