Pipeline

PALI-2108

Targeted PDE4 inhibition for inflammatory bowel disease

In Phase 2 development for
Ulcerative Colitis and Crohn’s disease.

PALI-2108 is a once-daily oral PDE4 inhibitor prodrug designed for targeted activation in the terminal ileum and colon. Across Phase 1 studies in healthy volunteers and patients with ulcerative colitis and fibrostenotic Crohn’s disease, PALI-2108 demonstrated favorable safety and tolerability, differentiated pharmacokinetics and sustained PDE4 inhibition above IC90, supporting advancement into Phase 2 development.

Targeted Bioactivation

Designed for localized activation in the terminal ileum and colon.

Once-Daily Oral

Sustained pharmacologic activity supports convenient once-daily dosing.

Validated PDE4 Biology

Built on a clinically validated anti-inflammatory mechanism with potential anti-fibrotic activity.

Sustained PDE4 Inhibition

Phase 1 data demonstrated plasma exposure above IC90 with once-daily dosing.

Phase 2 Clinical Development Program

PALI-2108 is being advanced through distinct Phase 2 development programs in ulcerative colitis and Crohn’s disease.

Phase 2 study in ulcerative colitis

ACTIVE PROGRAM

Global, randomized, double-blind, placebo-controlled
Moderately to severely active ulcerative colitis
Approximately 204 patients
15 mg and 30 mg once daily versus placebo
12-week induction period
Primary endpoint: Clinical Remission using the Modified Mayo Score
50% of patients expected to have failed advanced therapy
Primary readout expected H2 2027

Planned open-label Phase 2a study in Crohn’s disease

PLANNED PROGRAM

Open-label study
Moderate-to-severe Crohn’s disease
Approximately 50–60 patients
Study design being finalized
Enrollment anticipated in 2026/27
Primary readout expected in 2027/28

PHASE 1 DATA AND POSTERS

The Phase 1 clinical program in healthy volunteers and patients with ulcerative colitis and fibrostenotic Crohn’s disease established the clinical and pharmacologic foundation for Phase 2 development.

Phase 1 Clinical Program Overview

Safety, tolerability, pharmacokinetic and pharmacodynamic findings across the PALI-2108 Phase 1 clinical program.

Ulcerative Colitis Phase 1b Results

Clinical, pharmacokinetic and biological findings from patients with ulcerative colitis.

Fibrostenotic Crohn’s Disease Phase 1b Results

Clinical and pharmacokinetic findings from patients with fibrostenotic Crohn’s disease.

Key Phase 1 Findings

Favorable safety and tolerability
Sustained plasma trough concentrations above IC90
High intestinal tissue exposure
Differentiated pharmacokinetic profile
Preliminary evidence of biological and clinical activity