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Theravance’s izencitinib fails in Phase IIb ulcerative colitis trial

Theravance Biopharma has reported that its drug candidate izencitinib (TD-1473) failed to meet the primary endpoint in Phase IIb dose-finding induction clinical trial to treat ulcerative colitis.

Meant for oral administration, izencitinib is a pan-Janus kinase (JAK) inhibitor being jointly developed by Theravance and Janssen Biotech. The drug targets inflammation at the gastrointestinal disease site.

Theravance is specifically developing the drug for various inflammatory intestinal diseases such as ulcerative colitis and Crohn’s disease.

The randomised, double-blind, placebo-controlled, multi-centre Phase IIb trial enrolled adults with moderately-to-severely active ulcerative colitis.

Safety and efficacy results from this trial were expected to help determine induction and maintenance dose regimens for a confirmatory Phase III induction trial and a maintenance study that is underway.

However, top-line results showed that the Phase IIb trial did not meet its primary goal of change in the total Mayo score or the main secondary goal of clinical remission at week 8, when compared to placebo.

Data revealed a small dose-dependent rise in clinical response measured using the adapted Mayo score, due to a decrease in rectal bleeding.

All evaluated izencitinib doses were observed to be well-tolerated on oral administration once a day for eight weeks.

24 Aug 2021

https://www.clinicaltrialsarena.com/

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