Duvakitug Phase 2b data show durable IBD remission at 44 weeks

Teva Pharmaceutical Industries and Sanofi have presented long-term extension data from the RELIEVE UCCD phase 2b study showing that duvakitug, their investigational anti-TL1A monoclonal antibody, sustained clinically meaningful outcomes across multiple endpoints in patients with moderately-to-severely active ulcerative colitis (UC) and Crohn's disease (CD). The results were disclosed at UEG Week 2026 in Barcelona on 20 October.

The extension study enrolled 130 responders from the 14-week induction phase, re-randomising them to subcutaneous duvakitug at either 450 mg or 900 mg every four weeks for up to 44 additional weeks. Both doses performed, and the higher dose produced numerically superior results in each indication, consistent with a dose-response relationship.

Phase 2b results in detail

In UC, clinical remission rates at week 44 were 47% at the lower dose and 58% at the higher dose, as measured by the modified Mayo Score. Clinical response rates reached 82% and 87% respectively, while endoscopic improvement was recorded in 59% and 63% of patients. The endoscopic improvement threshold required a Mayo Endoscopic Score of 0 or 1, indicating inactive or only mildly active mucosal disease.

In CD, endoscopic response at week 44, defined as a 50% or greater reduction in Simple Endoscopic Score for Crohn's Disease from baseline, was seen in 41% of patients receiving 450 mg and 55% receiving 900 mg. Clinical remission by the Crohn's Disease Activity Index was recorded in 81% and 84% of patients respectively, with clinical response rates of 81% and 87%.

Walter Reinisch, Director of the Inflammatory Bowel Disease Study Group at the Medical University of Vienna and a co-lead investigator, said the results "underscore the potential of duvakitug to deliver effective and durable relief from persistent inflammation and symptoms, supporting better long-term disease management."

Safety was broadly consistent with the induction period. The most common adverse events in UC were upper respiratory tract infection and nasopharyngitis; in CD these were joined by hypertension, anaemia, and influenza. Discontinuation rates due to adverse events were low, ranging from 2% to 6% across arms and indications. Biomarker analyses also presented at the congress indicated reductions in markers of neutrophilic inflammation and, in CD, tissue remodelling, lending mechanistic support to the TL1A inhibition hypothesis.

Competitive context and next steps

The IBD biologics landscape is crowded, with multiple approved mechanisms already in use, including anti-TNF agents, integrin inhibitors, and IL-12/23 inhibitors. More recently, selective IL-23 inhibitors such as risankizumab and mirikizumab have raised the efficacy bar in both UC and CD, making durable endoscopic improvement an increasingly important differentiator for any new entrant.

TL1A is a newer target, and duvakitug is among the leading candidates in the class. Rosnilimab, a PD-1 agonist from AbbVie following its acquisition of Landos Biopharma, and TEV-48574 programme expansions from Teva itself represent adjacent competitive activity. The potential for duvakitug to address fibrosis alongside inflammation is a key commercial proposition, particularly in fibrostenotic CD, where no approved anti-fibrotic therapy exists.

Teva and Sanofi have already initiated two phase 3 programmes each in UC and CD under the SUNSCAPE and STARSCAPE study names. A phase 2 study in hidradenitis suppurativa, the AURALIGHT study, is also under way, and a separate phase 2 in fibrostenotic CD is in planning. The two companies are splitting development costs equally and sharing net profits in major markets, with Teva leading commercialisation in Europe and Israel. Regulatory submissions will depend on phase 3 readouts, and no timeline for those has been disclosed.