PALI-2108 for Ulcerative Colitis

(ASCENTRA-UC Trial)

This trial explores a new treatment called PALI-2108 for individuals with moderate to severe ulcerative colitis, an inflammatory condition affecting the colon. The goal is to determine if PALI-2108 is effective and safe compared to a placebo (a substance with no active medicine). Participants will receive one of two doses of PALI-2108 or a placebo. Ideal candidates have had ulcerative colitis for at least three months and have experienced issues with current treatments.

As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Research has shown that PALI-2108 was safe in past studies. In one study with healthy volunteers, researchers reported no serious health problems. Specifically, they observed no major health issues, unusual lab results, or heart test (EKG) concerns. These findings suggest that PALI-2108 is well-tolerated by the body. While promising, ongoing studies are necessary to confirm its safety and effectiveness for people with ulcerative colitis.¹²³⁴⁵

Researchers are excited about PALI-2108 for ulcerative colitis because it offers a fresh approach compared to current treatments like mesalamine, corticosteroids, and biologics. Unlike these standard options, PALI-2108 is designed to be taken once daily (QD) and targets a specific pathway involved in inflammation, potentially leading to fewer side effects and improved patient compliance. The study is testing two doses, 15mg and 30mg, to find the optimal balance between effectiveness and safety, which could provide a more tailored treatment option for patients.

Research has shown that PALI-2108 may help treat ulcerative colitis. In one study, all five patients with ulcerative colitis who took PALI-2108 showed improvement, and two experienced a significant reduction in symptoms. Another study found a 62.8% drop in the modified Mayo score, which measures disease activity, with one person achieving remission. Animal studies also support this, showing that PALI-2108 reduced colitis symptoms in mice. These findings suggest that PALI-2108 could be effective for people with moderate to severe ulcerative colitis. Participants in this trial will receive either PALI-2108 at different doses or a placebo to further evaluate its effectiveness.⁶⁷⁸⁹¹⁰