Bristol-Myers Phase 3 Zeposia Study in Ulcerative Colitis Meets Key Endpoints
June 02 2020 - 8:12AM
Dow Jones News
By Colin Kellaher
Bristol-Myers Squibb Co. on Tuesday said a pivotal Phase 3 study
evaluating Zeposia as an induction and maintenance therapy for
adults with moderate to severe ulcerative colitis met both primary
endpoints.
The New York biopharmaceutical company said Zeposia showed
highly statistically significant results for induction of clinical
remission at 10 weeks and in maintenance at 52 weeks in patients
with the chronic inflammatory bowel disease.
Bristol-Myers said the study also met key secondary endpoints of
clinical response and endoscopic improvement in induction at 10
weeks and in maintenance at 52 weeks.
The company said the safety profile of Zeposia in the study was
consistent with previous trials, adding that it plans to discuss
the study results with health authorities.
Bristol-Myers, which in March received U.S. Food and Drug
Administration for Zeposia for adults with relapsing forms of
multiple sclerosis, is developing the drug for additional
immune-inflammatory indications, including ulcerative colitis and
Crohn's disease.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
June 02, 2020 07:57 ET (11:57 GMT)
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