Palisade Bio receives Health Canada clearance for FSCD drug trial

CARLSBAD, CA - Palisade Bio, Inc. (NASDAQ:PALI), a micro-cap biotech company with a market capitalization of $5.72 million, announced Friday it has received a No Objection Letter from Health Canada for its Clinical Trial Application to evaluate PALI-2108 in a Phase 1b study for fibrostenotic Crohn’s disease (FSCD). According to InvestingPro analysis, the company maintains a stronger cash position than debt, though it faces profitability challenges with an EBITDA of -$12.12 million.

The open-label study will enroll approximately 6-12 patients to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of PALI-2108, described as a first-in-class, ileocolonic-targeted PDE4 B/D inhibitor. Patient dosing is expected to begin in the second half of 2025, with topline data anticipated in the first quarter of 2026. While the stock has faced significant headwinds, declining 82.76% over the past year, analyst price targets range from $2 to $14, suggesting potential upside if clinical trials succeed.

FSCD, which develops in up to half of Crohn’s disease patients, currently has no approved anti-fibrotic therapies. Existing treatments primarily address symptoms rather than the underlying fibrotic disease process.

"This Health Canada clearance marks an important milestone for PALI-2108 as the first dual anti-inflammatory and anti-fibrotic therapy in development for FSCD," said Dr. Mitchell Jones, Chief Medical Officer of Palisade Bio, in the press release.

The company indicated that data from this study, combined with results from completed Phase 1a/1b trials in ulcerative colitis, will support its planned Phase 2 IND submission to the U.S. Food and Drug Administration in the first half of 2026.

PALI-2108 is designed for gut-restricted delivery, with activation occurring through bacterial enzymes in the lower intestine. This approach aims to achieve high local tissue concentrations while minimizing systemic exposure, potentially avoiding tolerability issues associated with systemic PDE4 inhibitors.

Palisade Bio focuses on developing therapeutics for autoimmune, inflammatory, and fibrotic diseases. InvestingPro subscribers have access to 8 additional key metrics and insights about PALI’s financial health, which currently shows a Weak overall score of 1.68. Discover more comprehensive analysis and real-time updates by exploring InvestingPro’s advanced financial tools.

In other recent news, Palisade Bio announced positive clinical data for its drug PALI-2108, which is being developed for ulcerative colitis and fibrostenotic Crohn’s disease. In a Phase 1b open-label study, all five patients with moderate-to-severe ulcerative colitis who received PALI-2108 for seven days showed clinical response, with an average reduction of 62.8% in the modified Mayo score. Additionally, four out of five patients demonstrated decreased fecal calprotectin levels, with a mean reduction of 70%. Further strengthening its position, Palisade Bio has secured a patent allowance in China for PALI-2108. This patent covers composition of matter claims for the drug and extends protection into 2045, subject to potential regulatory extensions. The company also announced the appointment of Emil Chuang to its Board of Directors. Dr. Chuang brings nearly 25 years of pharmaceutical and clinical experience, including leadership roles in drug development programs that led to regulatory approvals. These recent developments highlight the company’s ongoing progress in advancing its therapeutic pipeline.

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