- Celgene Corp.'s Phase 2 study results, presented at the World Congress of Gastroenterology at ACG2017, have shown that ozanimod has benefits in both Crohn's disease and ulcerative colitis.
- In the open-label STEPSTONE Crohn's disease study, daily ozanimod reduced simple endoscopic score for Crohn's disease (SES-CD) by at least 50% for 27% of patients. The drug also reduced symptoms by 25% in 43% of patients, and reduced Crohn's disease activity index (CDAI) at week four and week 12. At week 12, 46% of patients were in CDAI remission.
- At 92 weeks of the TOUCHSTONE open-label study in ulcerative colitis, 91% of patients had little or no disease, 97% had little or no blood in their stools, and 86% had no blood in their stools.
Celgene is currently enrolling patients in a Phase 3 study of ozanimod in ulcerative colitis, dubbed TRUE NORTH. Recruitment is expected to complete during the second half of 2017.
Ozanimod came into Celgene's pipeline in 2015, as part of its $7.2 billion Receptos acquisition, and has potential to hit a large market.
The drug is in Phase 3 for the treatment of multiple sclerosis. The results of the second Phase 3 study, RADIANCE, have been mixed, meeting its primary objective of a statistically significant reduction in annualized relapse rates compared with Biogen's Avonex (interferon β-1a), but failing to slow disability anymore than Avonex in this study. Celgene is still confident of ozanimod's potential as a blockbuster, and plans submission by the end of 2017.
Beyond the opportunity in multiple sclerosis, there is significant need in both Crohn's disease and ulcerative colitis.
In Europe and North America, around three in a thousand people have Crohn's disease and its incidence is increasing across all ethnic groups. While there are symptomatic treatments there is no cure and people with Cohn's disease have a slightly reduced life expectancy.
"The endoscopic, clinical improvement and the safety profile of ozanimod reported in the STEPSTONE study are encouraging and support its further development as a potential oral option for patients with Crohn's disease," said Brian G. Feagan, Robarts Clinical Trials and the University of Western Ontario in Canada.
Ulcerative colitis affects around one in 198 people in Europe and one in 402 people in North America. While it develops gradually, its complications may be life-threatening.