Results from the phase IIb ANTHEM-UC trial, presented at the American College of Gastroenterology annual meeting, show that the oral peptide icotrokinra produced durable responses in patients with moderately to severely active ulcerative colitis. Across the 100-mg, 200-mg, and 400-mg dose groups, clinical response rates at week 76 ranged from 72.7% to 81.3%, clinical remission rates from 56.3% to 59.1%, and endoscopic improvement rates from 63.6% to 68.2%. Nearly all patients in remission (97%) were corticosteroid-free.
The long-term extension data build on the initial 12-week results, which had shown clinical response rates of 55–63% for the drug versus 27% for placebo. Symptomatic remission was seen as early as week 4 and was maintained or improved through week 76. Maria Abreu of Cedars-Sinai Medical Center, who presented the findings, noted that patients who responded did not lose response over time, and that even those previously exposed to advanced therapies had remission rates above 50%.
Adverse events were more frequent with icotrokinra than placebo, including worsening ulcerative colitis, upper respiratory tract infection, nasopharyngitis, headache, and arthralgia, but rates of serious adverse events and discontinuations were not higher. The drug is already FDA-approved for plaque psoriasis, and the phase III ICONIC-UC trial is evaluating it in ulcerative colitis. Abreu suggested that, if approved, the oral drug could serve as a first-line advanced therapy.