Theravance's Gut-Selective JAK Inhibitor Disappoints In Ulcerative Colitis Study
Crohn's Disease Data Awaited On Izencitinib
Top-line results from a Phase IIb study of Theravance’s potential gut-selective JAK inhibitor izencitinib have not matched expectations, and results from a similar early-stage study in Crohn’s disease with the Janssen-partnered candidate are now awaited at the end of the year or in early 2022.
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The Phase III failure of ampreloxetine in nOH followed disappointing Phase IIb data for izencitinib in ulcerative colitis in August. Theravance narrows focus to respiratory disease, including label expansions for Yupelri.
Safety appears balanced between the drug and placebo arms in upadacitinib’s third Phase III trial in ulcerative colitis, but there were low numbers of MACE and there are lingering safety concerns about the JAK class overall.
Market Snapshot: The ulcerative colitis market looks set to experience strong pricing pressure over the next three to five years, with leading players losing exclusivity for their drugs and a flood of novel entrants set to hit the market.