AbbVie’s Dual-Target Drug Shows Phase 2 Results for Hard-to-Treat Crohn’s Disease

AbbVie (NYSE:ABBV) today announced that its investigational ABBV-466, a novel dual-targeting therapy against IL-23 p19 and integrin α4β7, demonstrated higher rates of endoscopic remissiona at Week 12 than either monotherapy in patients with Crohn's disease (CD). The difference in endoscopic remissiona rates between ABBV-466 and monotherapy groups further increased at Week 24. The findings are from the TARGET-CD study, an ongoing open-label, treat-through, Phase 2a platform study in patients with moderate to severe CD.1,2 The findings will be presented as a late-breaking abstract at the ongoing 2026 Annual United European Gastroenterology Week (UEGW) Congress in Barcelona, October 17–20.

"ABBV-466 reflects how we are building the next generation of our inflammatory bowel disease (IBD) portfolio, leveraging insights from our own research to address disease pathways that may remain active even when a central inflammatory pathway is inhibited," said Kori Wallace, M.D., vice president, global head of immunology clinical development, AbbVie. "Our research pointed to evidence of α4β7-driven inflammation despite risankizumab's IL-23 p19 inhibition, leading us to augment risankizumab with a novel α4β7 inhibitor, trosunilimab. The TARGET-CD results reinforce our strategy of advancing therapies designed around the complex biology of Crohn's disease."

The TARGET-CD study included 300 patients (94, 100, and 106 patients in the anti-IL-23 p19 (risankizumab), anti-α4β7 (trosunilimab), and ABBV-466 treatment groups, respectively) with moderately to severely active Crohn's disease across the spectrum of disease severity and prior treatment experience. While 25% of patients were biologic-naïve, 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; 25% had failed three or more advanced therapies. This patient population reflects the real-world complexity of Crohn's disease, where heterogeneous disease biology can contribute to differences in treatment response across patients.1

At Week 12, 30.2% of patients treated with ABBV-466 achieved the primary endpoint of endoscopic remissiona, compared to 21.3% and 18.0% of patients receiving anti-IL-23 p19 monotherapy and anti-α4β7 monotherapy, respectively. An improvement with ABBV-466 was also reported at Week 24, with 40.5% of ABBV-466 treated patients achieving endoscopic remissiona, compared to 22.4% and 20.0% of patients on risankizumab and trosunilimab monotherapy, respectively.1

Based on gene expression analyses, ABBV-466 showed colonic epithelial repair and barrier restoration at Week 12, followed by tissue remodeling and metabolic changes at Week 24 that were generally not observed with either monotherapy.1 

"Many patients with Crohn's disease move from one advanced therapy to the next and still have active inflammation in the bowel, even when their symptoms improve," said Remo Panaccione, M.D., Professor of Medicine and Director of the Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary. "Endoscopic remission is a goal we aim for, because ongoing inflammation can drive disease progression over time. 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."

Rates of serious adverse events (SAEs) for ABBV-466 were 10.4% and comparable to risankizumab monotherapy (9.6%) and trosunilimab monotherapy (9.0%). In the ABBV-466 and trosunilimab monotherapy arms, the most common adverse events (≥5%) were Crohn's disease and nausea. In the risankizumab monotherapy arm, the most common adverse events (≥5%) were Crohn's disease and arthralgia.