Palisade Bio Reports Early Crohn’s Disease Improvements as PALI-2108 Advances in Phase 2

Key Points

• Five Crohn’s disease patients showed a 47.5% reduction in average endoscopic disease activity after 14 days of PALI-2108 treatment.
• Average fecal calprotectin, a marker of intestinal inflammation, declined by 58.8%.
• A separate five-patient ulcerative colitis study reported clinical response in all participants after seven days.
• Palisade is enrolling its Phase 2b ulcerative colitis trial and initiating a Phase 2a Crohn’s disease study.
• The early studies were small, short and had no placebo groups. Larger trials must confirm the findings.

Palisade Bio (NASDAQ: PALI) presented findings at UEG Week 2026 in Barcelona that support continued development of PALI-2108, its experimental oral treatment for inflammatory bowel disease.

The presentations combined previously reported patient results with additional drug-exposure and tissue analyses. Together, they suggest the treatment reaches the intestine and acts on its intended PDE4 target, but they do not establish lasting clinical benefits.

Five-Patient Crohn’s Study Shows Improvement After Two Weeks

The Phase 1b study included five patients with longstanding Crohn’s disease and symptomatic narrowing in the small intestine. Four were also receiving biologic treatments, making it harder to isolate PALI-2108’s contribution.

After 14 days, average endoscopic disease activity fell by 47.5%, and average fecal calprotectin declined by 58.8%. Two patients met criteria for endoscopic response, and two met criteria for endoscopic remission.

All reported side effects were mild, with no serious adverse events or treatment discontinuations. However, five patients followed for two weeks cannot establish long-term safety.

Exploratory tissue and blood-marker findings also supported further study of possible effects on tissue remodeling. They do not demonstrate reversal of intestinal scarring or narrowing.

Ulcerative Colitis Findings Support Larger Placebo-Controlled Trial

In a separate five-patient ulcerative colitis cohort, all participants achieved clinical response after seven days, and two achieved clinical remission. Tissue analyses also showed reduced inflammation.

That early study used a regimen titrated to 30 mg twice daily. The ongoing Phase 2b ASCENTRA-UC trial is testing 15 mg and 30 mg once daily against placebo in approximately 204 patients.

Drug-Exposure Data Support Once-Daily Development

In evaluated Crohn’s disease patients, concentrations of PALI-0008, the drug’s active form, were approximately 7.3 times higher in intestinal tissue than peak blood concentrations.

Additional findings supported sustained exposure over 24 hours at a 30 mg once-daily dose. These results strengthen the rationale for once-daily testing, rather than prove that the regimen delivers sustained symptom relief.

Investor Takeaway: Phase 2 Results Will Be the More Meaningful Test

For PALI investors, the update adds biological evidence to encouraging early patient findings. The company is advancing both its ulcerative colitis and Crohn’s disease programs.

The central limitation remains the small, uncontrolled studies. Larger trials will need to establish effectiveness, safety and durability. PALI-2108 is not approved for any indication.