Palisade Bio Inc. (NASDAQ: PALI) recorded a 14% increase in its share price on Monday after the U.S. Food and Drug Administration granted clearance of the company's Investigational New Drug application for PALI-2108. The clearance authorizes Palisade to initiate a global Phase 2 clinical program testing the candidate in people with moderately to severely active ulcerative colitis.
The cleared study, named ASCENTRA-UC, is planned as a multicenter, randomized, double-blind, placebo-controlled, dose-ranging Phase 2 trial. Palisade expects to enroll roughly 204 patients across North America and Europe and to evaluate two once-daily dose levels of PALI-2108 - 15 mg and 30 mg - against placebo.
Under the company's timeline, the first patient is anticipated to be enrolled in the second half of 2026. Primary efficacy readout for the study is targeted for the second half of 2027. The trial's primary endpoint will be clinical remission at Week 12, as assessed by the modified Mayo Score.
Secondary measures in ASCENTRA-UC will include assessments of clinical response, endoscopic improvement and histologic-endoscopic mucosal improvement. Patients who meet eligibility after the initial 12-week induction period will be able to continue into a 36-week maintenance phase intended to evaluate the durability of response through Week 48.
PALI-2108 is described by the company as a once-daily oral phosphodiesterase 4 (PDE4) inhibitor prodrug that is designed to be selectively bioactivated in the terminal ileum and colon. Palisade has engaged PSI, a contract research organization, to oversee execution of the ASCENTRA-UC program.
In addition to the ulcerative colitis study, Palisade said it plans to submit an IND application for ASCENTRA-CD, a parallel trial in Crohn's disease, in the second half of 2026.
Context and implications
The FDA clearance allows Palisade to proceed with a pivotal Phase 2 program that will measure both short-term induction outcomes at Week 12 and longer-term maintenance through Week 48. The trial is set up to capture multiple efficacy and safety measures, along with pharmacokinetic and pharmacodynamic data, across the two dosing regimens.
Operationally, Palisade will rely on its CRO partner to manage site activation and trial conduct across North America and Europe as it works toward enrollment and the planned timelines for data readout.