UEGW delegates hear of strides forward in IBD treatment

At Europe's main gastroenterology get-together this week, a series of new studies from big pharma groups promised improvements in the care of people living with ulcerative colitis (UC) and Crohn's disease, the two most common forms of inflammatory bowel disease.

Here are some of the clinical highlights of the United European Gastroenterology Week (UEGW) in Barcelona, Spain, which shut its doors yesterday.

Lilly eyes label expansion for Omvoh in paediatric UC

While relatively uncommon, UC that starts in childhood tends to be more extensive and severe than when it emerges in adulthood, and on-label treatment options for younger patients are fairly limited.

Lilly hopes to extend the available medicines for children after reporting positive results in the phase 3 SHINE-2 study, which involved patients aged six to 17 with moderately to severely active UC and studied the safety and efficacy of induction and maintenance treatment with IL-23p19 inhibitor Omvoh (mirikizumab), currently approved for treating adults with both UC and Crohn's. More than 80% of patients responded to induction treatment with Omvoh, while half of responders were in clinical remission at one year's follow-up.

The company said it plans to submit the SHINE-2 data to global regulators to support potential label expansions for Omvoh, which made $182 million in global sales in the first half of this year. Approval of a paediatric label claim could give Lilly a leg-up in the fiercely competitive UC market, making it an option for around 25,000 children in the US alone.

Gilead's oral drug for UC promising in SWIFT trial

Gilead Sciences chalked up a phase 2 success for oral α4β7 integrin inhibitor emvistegrast (GS-1427) in adults with moderately to severely active UC, one of a series of planned indications for the drug.

The ongoing SWIFT found that a 200 mg dose of emvistegrast achieved a clinical response in 66% of patients at week 12, compared to 37% of a matched placebo group. Clinical remission at that time point was achieved in 31% and 8% of subjects, respectively, and the drug was generally well tolerated with a low rate of treatment discontinuations.

Gilead now plans to start a phase 3 trial of emvistegrast monotherapy, hoping to bring it to market as an oral alternative to Takeda's $6.4 billion-a-year blockbuster Entyvio (vedolizumab), which is dosed by intravenous infusion or self-administered subcutaneous injection. Its closest oral rival is Lilly's zotemtograst, which missed the mark in a phase 2a UC trial but remains in mid-stage development for both UC and Crohn's disease.

Entyvio breaks new ground in the treatment of UC

More than a decade after its first approvals for IBD, Takeda's Entyvio continues to push the boundaries of treatment. New data from the VERDICT trial show that aggressive treatment with the IV formulation of the drug can reduce the risk of UC complications, such as hospitalisation, colectomy surgery, or the need for rescue therapy, in moderate to severe UC.

The study used a "treat-to-target" approach, monitoring patients' disease and adjusting treatment on a set schedule until their disease had cleared – at a histological level – and they no longer needed corticosteroids. Compared with the standard treatment approach, there was a near-70% reduction in UC complication risk overall up to 80 weeks, while the time before developing a complication was extended by around two-thirds.

Lead author Vipul Jairath of Western University in Canada said the study provides strong evidence that "implementation of a treat-to-target strategy can change the disease course" in moderate to severe UC.

AbbVie makes case for dual-acting drug ABBV-466 in Crohn's

Targeting α4β7 and IL-23 are both well-established strategies in IBD, so combining the two mechanisms makes sense. At UEGW, AbbVie presented the first proof-of-concept data on ABBV-466, a doublet therapy based on IL-23 inhibitor risankizumab – the active ingredient in its big-selling Skyrizi product – with experimental α4β7 inhibitor trosunilimab.

In the TARGET-CD study, patients with moderate-to-severe Crohn's and a varied history of prior treatment were randomised to either Skyrizi, trosunilimab, or ABBV-466. At week 12, the rate of endoscopic remission in the three treatment groups was 21.3%, 18.0%, and 30.2%, respectively. ABBV-466 also performed better at week 24, with a remission rate of 40.5% compared to 22.4% with Skyrizi and 20.0% with trosunilimab.

Gene expression analysis showed that ABBV-466 led to intestinal tissue repair and barrier restoration by week 12, and tissue remodelling and metabolic changes by week 24, which "were generally not observed with either monotherapy," said AbbVie.

IBD study shows long-term benefit of Sanofi and Teva's duvakitug

Sanofi and partner Teva revealed new data at UEGW from the phase 2b RELIEVE UCCD of duvakitug, their anti-TL1A antibody, showing that it can help to maintain long-term positive outcomes in both UC and Crohn's over 44 weeks. Induction results from the study were reported in 2024, and duvakitug is now in a phase 3 programme in both indications.

In UC patients, maintenance treatment with duvakitug maintained clinical remission in up to 58% of patients, with 87% remaining in clinical response and 63% still showing endoscopic improvement. In Crohn's – recognised as more complex and harder to treat – those numbers came in at up to 55%, 87%, and 84%, respectively.

Sanofi and Teva are in a race to market in the anti-TL1A class with Roche and MSD, which both have drugs in the category – respectively afimkibart and tulisokibart – in late-stage testing. Following are Spyre Therapeutics, with its phase 2-ready candidate SP002, and other companies with early-stage candidates like Earendil Labs, Xencor and Absci.