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May 9, 2017

AbbVie’s ABT-494 demonstrates positive outcome in Phase II trial for Crohn’s disease

AbbVie has reported positive results from the Phase II CELEST clinical trial of upadacitinib (ABT-494) for the treatment of patients with Crohn's disease.

AbbVie has reported positive results from the Phase II CELEST clinical trial of upadacitinib (ABT-494) for the treatment of patients with Crohn's disease.

Upadacitinib is an oral, selective inhibitor of JAK1, which is considered to be pivotal in the pathophysiology of the disease.

Results from the randomised, double-blind, placebo-controlled Phase II trial indicated that the number of patients experiencing endoscopic remission was more in the case of treatment with 24mg or 6mg of upadacitinib twice-daily when compared to placebo.

The trial assessed the safety and efficacy of various dosing regimens of upadacitinib over 16 weeks in adults with moderately to severely active Crohn's disease.

"For nearly two decades, AbbVie has pioneered research in immune-mediated diseases, and these findings demonstrate our commitment to meaningful scientific innovation with the potential to improve patient lives."

AbbVie research and development executive vice-president and chief scientific officer Michael Severino said: "Results from CELEST are encouraging and provide new information to the gastroenterology community on the potential for upadacitinib as an oral treatment option for patients with Crohn's disease.

"For nearly two decades, AbbVie has pioneered research in immune-mediated diseases, and these findings demonstrate our commitment to meaningful scientific innovation with the potential to improve patient lives."

The safety profile of upadacitinib was found to be consistent with the results obtained from its trials for the treatment of rheumatoid arthritis.

The overall adverse events (AEs) and infections in the Phase II trial were found to be numerically higher compared to placebo, but are not considered to be dose-related.

The ongoing trial will continue assessing patients up to 52 weeks.

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