Phase III study of APD 334 meets primary endpoint in ulcerative colitis.- Pfizer
Pfizer announced positive topline results from a Phase III study of APD 334 (etrasimod), an investigational, oral, once-a-day, selective sphingosine 1-phosphate (S1P) receptor modulator in development for the treatment of moderately to severely active ulcerative colitis (UC). In the study, etrasimod patients achieved statistically significant improvements in the primary endpoint of clinical remission at week 12 as compared with placebo.
Statistically significant improvements were achieved in all key secondary endpoints in the trial as well. The safety profile was consistent with previous Phase II studies.
The global phase III multi-center, randomized, double-blind, placebo-controlled study, also known as ELEVATE 12, enrolled 354 UC patients who had previously failed or were intolerant to at least one conventional, biologic, or JAK therapy. Participants received etrasimod 2mg once daily. Full results from the study will be submitted for future scientific publication and presentation. These data along with results from ELEVATE 52 are expected to form the basis for planned future regulatory filings. Results from the ELEVATE 52 study will be available by the end of Q1.
Related news and insights
Novavax is awaiting US emergency use authorization for its prototype COVID-19 vaccine and is committed to bringing it to market. Clinical data generated to-date demonstrate that this prototype vaccine offers broad immune responses including against circulating variants, such as the Omicron BA.4/5.