Monday, October 26, 2015

Celgene's Phase 2 Maintenance Data from Ozanimod in Ulcerative Colitis Impresses Again

Celgene (NASDAQ: CELG) presented results from the maintenance phase of the TOUCHSTONE phase 2 trial of Ozanimod in patients with moderate to severe ulcerative colitis. The abstract wowed the crowd and won a "Top Abstract" prize at the United European Gastroenterology Week in Barcelona, just days after impressing at the American College of Gastroenterology Meeting in Honolulu.
Touchstone evaluated safety and efficacy of 0.5 mg and 1.0 mg doses of the SP1 modulator. The larger dose met its endpoints during the 8-week induction phase stage of the trial, but it's the maintenance data that's most promising.  After 32 weeks results point to a sustained effect that should give Celgene all it needs to confidently go forward with a larger phase 3 trial and hopefully an eventual NDA. At Week 32, clinical remission occurred in 20.9% receiving 1.0 mg (p=0.0108 vs. placebo), 26.2% receiving 0.5 mg (p=0.0021), and 6.2% receiving placebo.
Here's the winning abstract.

No comments:

Post a Comment