Oral Peptide Shows Durable Efficacy In Ulcerative Colitis

TL;DR

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Phase IIb ANTHEM-UC extension results presented at the American College of Gastroenterology meeting showed that many patients who continued oral icotrokinra had clinical response, remission or endoscopic improvement at week 76. The findings come from patients who responded by week 28 and entered the extension, so they do not establish long-term outcomes for everyone who began the trial. A phase III study is underway.

Patients with moderately to severely active ulcerative colitis who continued the oral drug icotrokinra in a phase IIb trial extension often remained in clinical response or remission at week 76, according to results presented at the American College of Gastroenterology annual meeting. The findings suggest sustained benefit among participants who qualified to continue treatment, but do not show that the drug works equally well over that period for every patient who started the study.

In the long-term extension of the ANTHEM-UC trial, patients receiving daily doses of 100 mg, 200 mg or 400 mg had clinical response rates of 81.3%, 72.7% and 72.7%, respectively, at week 76. Clinical remission rates were 56.3%, 59.1% and 56.8%; investigators reported that 97% of patients in remission were corticosteroid-free. Endoscopic improvement rates were 64.6%, 68.2% and 63.6% across the same dose groups.

Those percentages describe the extension population, not the full group initially randomized. Patients who achieved a clinical response at week 28 could continue study treatment in the extension. The report said 85% of participants stayed in the long-term study over 76 weeks. That selection matters when interpreting the results: the figures show how outcomes held up among those continuing in the extension, rather than providing a direct comparison of all original participants at week 76.

At the meeting, Maria Abreu, MD, of Cedars-Sinai Medical Center, said symptomatic remission appeared as early as week 4 and was maintained or improved through week 76. She told MedPage Today, “People didn’t lose the response. The ones that responded continue to do well.” The extension results were reported across dose groups; the available account does not provide a placebo comparison for these week-76 outcomes.

A Daily Oral Option Under Study

Ulcerative colitis is a chronic inflammatory disease, and treatments can lose effectiveness over time for some patients. Sustained response among extension participants is relevant because it addresses whether early improvement persisted during longer follow-up, rather than only whether symptoms changed in the initial weeks. The report also describes the treatment as an oral peptide that blocks the IL-23 receptor, a different approach from injectable or infused biologic medicines that target circulating cytokines.

Abreu said an oral medicine with early and durable responses could have a role as a first-line advanced therapy if approved for ulcerative colitis. That is her assessment, not an established treatment recommendation or a conclusion from a completed phase III trial. The long-term findings are encouraging but remain preliminary; comparative effectiveness, broader safety, and how well the results apply outside the selected extension group still need evaluation.

From Week 12 to Long-Term Follow-Up

ANTHEM-UC randomized 252 adults across 115 sites to icotrokinra at 100 mg, 200 mg or 400 mg, or placebo. Participants had moderately to severely active disease and a history of glucocorticoid dependence, inadequate response or unacceptable side effects with specified treatments, or inadequate response or side effects with at least one approved advanced therapy. The trial therefore studied a group with substantial prior treatment needs.

In the original 12-week phase, published in the New England Journal of Medicine, clinical response was reported in 55%, 58% and 63% of patients in the three icotrokinra dose groups, compared with 27% on placebo. The source report said all three comparisons met the trial’s primary endpoint. The U.S. Food and Drug Administration approved icotrokinra earlier in 2026 for plaque psoriasis in adults and children aged 12 and older; that approval does not cover ulcerative colitis.

““What’s nice is that it is an oral drug, and we know it’s safe.””

— Maria Abreu, MD, speaking to MedPage Today

Limits of the Week-76 Findings

The reported week-76 outcomes apply to patients who responded by week 28 and continued into the extension. The source does not give a week-76 placebo comparison or enough detail to determine how outcomes would differ for all 252 randomized participants, including those who did not qualify for extension treatment. Although 85% stayed in the extension over 76 weeks, the report does not fully explain the reasons other participants left or how missing outcomes were handled.

Safety also requires continued scrutiny. Adverse events were more frequent in the icotrokinra groups than in the placebo group, including worsening ulcerative colitis, upper respiratory tract infection, nasopharyngitis, headache and joint pain. The report said serious adverse events and events leading to treatment discontinuation were not more common in the drug groups than in placebo, but it does not provide detailed event rates in the account. The longer-term results do not establish that icotrokinra is safe or effective for every patient.

Phase III Trial Will Test Broader Use

The phase III ICONIC-UC trial is evaluating icotrokinra in adults and adolescents with moderately to severely active ulcerative colitis. Its results will be needed to assess the drug in a larger confirmatory program and help clarify its benefits and risks. Icotrokinra is not reported as approved for ulcerative colitis; the psoriasis approval does not establish authorization for this condition.

Further reporting and trial results will need to clarify outcomes across all enrolled patients, the role of different doses, longer-term safety and how the drug compares with existing treatment options. Until those data are available, the week-76 findings are best understood as evidence of continued response among selected patients who remained on treatment.

Key Questions

What did the ANTHEM-UC extension report?

At week 76, clinical response rates were 72.7% to 81.3% across the three icotrokinra dose groups in the long-term extension. Clinical remission rates ranged from 56.3% to 59.1%, and endoscopic improvement from 63.6% to 68.2%.

Do the week-76 results include everyone who started the trial?

No. Patients who achieved a clinical response at week 28 could continue into the extension. The reported rates describe that extension population, not all 252 people originally randomized.

Is icotrokinra approved for ulcerative colitis?

The source reports FDA approval in 2026 for plaque psoriasis in adults and children aged 12 and older. It does not report approval for ulcerative colitis; phase III testing for that condition is ongoing.

What safety findings were reported?

Adverse events were more frequent in icotrokinra groups than in the placebo group, including infections, headache, joint pain and worsening ulcerative colitis. The report said serious adverse events and events leading to discontinuation were not more common with icotrokinra, but detailed rates were not provided in the account.

Source: rss