AbbVie’s ABBV-466 Combo Outperforms Skyrizi in Crohn’s Phase 2 Trial

2 min read
Source: Fierce Biotech
AbbVie’s ABBV-466 Combo Outperforms Skyrizi in Crohn’s Phase 2 Trial
Photo: Fierce Biotech
TL;DR

AbbVie reported that its experimental dual-targeting therapy ABBV-466 achieved higher endoscopic remission rates than its blockbuster drug Skyrizi in a Phase 2 trial for Crohn’s disease. The combination of risankizumab and trosunilimab showed 30.2% remission at Week 12, compared to 21.3% for Skyrizi alone. The company is advancing a larger Phase 2 study to potentially fast-track Phase 3 development.

Key points

  • ABBV-466, combining IL-23 inhibitor risankizumab and alpha-4 beta-7 inhibitor trosunilimab, achieved 30.2% endoscopic remission at Week 12 in the TARGET-CD study.
  • Skyrizi monotherapy achieved 21.3% remission, while trosunilimab monotherapy achieved 18.0% at the same time point.
  • By Week 24, ABBV-466 remission rates rose to 40.5%, compared to 22.4% for Skyrizi and 20.0% for trosunilimab.
  • The trial included 300 patients, 75% of whom had failed at least one advanced therapy, reflecting a heavily pretreated population.
  • AbbVie launched a larger 2,000-patient Phase 2 study in July to further evaluate the combination in Crohn’s and ulcerative colitis.

Background

Skyrizi is a major revenue driver for AbbVie, generating over $10 billion in the first half of 2026. The company identified persistent inflammation despite IL-23 inhibition, prompting the development of ABBV-466 to address complementary disease pathways. This follows AbbVie’s earlier launch of Rinvoq, a JAK inhibitor for Crohn’s, which expanded its immunology portfolio.

How outlets are covering it

Fierce Biotech emphasized the commercial significance of Skyrizi and the strategic rationale for adding trosunilimab to address residual inflammation. Investing News Network focused on the clinical data, highlighting the Week 24 improvements and molecular evidence of tissue repair. Both sources noted the heavily pretreated patient population, but Fierce Biotech contextualized the results against prior Phase 3 Skyrizi trials, while Investing News Network highlighted the presentation at the UEGW Congress in Barcelona.

Why it matters

Success of ABBV-466 could position AbbVie to replace or augment Skyrizi with a more effective next-generation therapy, potentially extending the product’s lifecycle and addressing unmet needs in refractory Crohn’s disease. The dual-targeting approach may become a new standard for complex inflammatory bowel disease cases.

What to watch

AbbVie plans interim analyses of the ongoing 2,000-patient Phase 2 study to determine if higher doses of trosunilimab support efficacy, potentially accelerating Phase 3 trials. Results from the UEGW Congress in Barcelona will provide further insights into the therapy’s long-term impact.

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