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 phase followed by a 36-week maintenance phase
Primary endpoint: Clinical Remission using the Modified Mayo Score
50% of patients expected to have failed advanced therapy
Primary readout expected Q4 2027

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

IND Cleared

Open-label study
Moderate-to-severe Crohn’s disease
Approximately ~60 patients
30 mg orally once daily
12-week induction phase followed by a 36-week maintenance phase
Primary endpoint: Endoscopic Response at Week 12, defined as at least a 50% reduction from baseline
Primary efficacy readout expected Q1 2028

Publications