Palisade Bio begins dosing in fibrostenotic Crohn’s disease study

CARLSBAD, Calif. - Palisade Bio, Inc. (NASDAQ:PALI), a $168 million market cap biotechnology company, has dosed the first patients in a Phase 1b clinical study of PALI-2108 for fibrostenotic Crohn’s disease (FSCD), a condition that currently has no approved medical therapies. According to InvestingPro data, analyst targets for PALI range from $2 to $14, reflecting the market’s varied expectations for this clinical-stage company.

The open-label exploratory study will enroll approximately 6 to 12 patients with FSCD to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of once-daily oral dosing over a 14-day treatment period. Topline data are expected in the first quarter of 2026. The stock has shown strong momentum, with InvestingPro data indicating a remarkable 142% price return over the past six months, though analysts have recently revised earnings expectations downward.

PALI-2108 is described as a first-in-class, ileocolonic-targeted PDE4 inhibitor prodrug designed for targeted activation in the terminal ileum and colon. The drug candidate aims to provide high local tissue exposure with minimal systemic absorption.

"This mechanistic study is designed to generate critical insights into how PALI-2108 modulates inflammatory and fibrotic pathways in intestinal tissue," said Dr. Mitchell Jones, Chief Medical Officer of Palisade Bio, according to the company’s press release.

The study will include tissue-level pharmacology and molecular response assessments using paired ileal biopsies and peripheral blood mononuclear cells. Analyses will include RNA sequencing to characterize treatment-induced changes in inflammatory and fibrotic signaling.

Data from this study, combined with results from the company’s Phase 1a/1b ulcerative colitis program, are expected to support Phase 2 Investigational New Drug submissions to the FDA in the first half of 2026.

Palisade Bio is developing PALI-2108 as a dual-acting anti-inflammatory and anti-fibrotic candidate for both fibrostenotic Crohn’s disease and ulcerative colitis.

In other recent news, Palisade Bio, Inc. has announced the successful closing of its underwritten public offering, raising approximately $138 million in gross proceeds. This offering is part of their ongoing efforts to fund the development of their inflammatory bowel disease (IBD) drug. Additionally, Palisade Bio has regained compliance with Nasdaq’s minimum bid price requirement, a situation that had been pending since April 30. The company was previously at risk of being delisted due to its stock trading below $1.00 per share for an extended period. In a related development, Palisade Bio has received a Canadian patent for its lead drug candidate, PALI-2108, which offers protection through May 2041. This patent is crucial for the development of treatments for fibrostenotic Crohn’s disease and ulcerative colitis. Furthermore, the company’s special shareholder meeting was adjourned due to a lack of quorum, with plans to reconvene on October 10, 2025. These developments indicate Palisade Bio’s continued efforts to strengthen its financial position and intellectual property portfolio.

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