AbbVie's ABBV-466 shows higher remission rates in Crohn's trial

AbbVie (NYSE: ABBV) presented Phase 2a study data showing its investigational dual-targeting therapy ABBV-466 achieved higher endoscopic remission rates than either of its component monotherapies in patients with moderate to severe Crohn's disease.

The findings come from the TARGET-CD study, an open-label, treat-through Phase 2a platform trial of 300 patients randomized to receive ABBV-466, risankizumab (anti-IL-23 p19), or trosunilimab (anti-α4β7) for 24 weeks. ABBV-466 combines both agents to target complementary inflammatory pathways.

At Week 12, the primary endpoint, 30.2% of ABBV-466-treated patients achieved endoscopic remission, compared with 21.3% on risankizumab and 18.0% on trosunilimab. By Week 24, 40.5% of ABBV-466 patients reached endoscopic remission, versus 22.4% and 20.0% on risankizumab and trosunilimab, respectively.

The study population was heavily pretreated: 75% had failed at least one advanced therapy, including 9.3% who had failed prior IL-23 therapy and 12% who had failed a JAK inhibitor. Twenty-five percent were biologic-naïve.

Gene expression analyses showed colonic epithelial repair and barrier restoration at Week 12 in ABBV-466-treated patients, with tissue remodeling and metabolic changes observed at Week 24, effects not generally seen with either monotherapy.

Rates of serious adverse events were 10.4% for ABBV-466, 9.6% for risankizumab, and 9.0% for trosunilimab. The most common adverse events in the ABBV-466 and trosunilimab arms were Crohn's disease and nausea; in the risankizumab arm, they were Crohn's disease and arthralgia.

"Endoscopic remission is a goal we aim for, because ongoing inflammation can drive disease progression over time," said Remo Panaccione, M.D., professor of medicine at the University of Calgary. "What stands out in the TARGET-CD Phase 2a study is that a dual-targeting approach reached that goal more often than either therapy alone in a heavily pretreated population."

The data were presented as a late-breaking abstract at the 2026 Annual United European Gastroenterology Week Congress in Barcelona. ABBV-466 remains investigational and has not received regulatory approval.

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