• Data to be presented at the 8^th Annual Antifibrotic Drug Development (AFDD) Summit
• PALI-2108 may offer a solution for fibrostenotic Crohn’s disease by enhancing efficacy, safety, and therapeutic potential compared to traditional treatments

Carlsbad, CA, Nov. 21, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, a clinical-stage biopharmaceutical company focused on developing novel therapeutics for autoimmune, inflammatory, and fibrotic diseases, today announced preclinical results for PALI-2108, a novel local PDE4 inhibitor prodrug. In recent studies using the Dextran Sulfate Sodium (DSS) colitis mouse model, PALI-2108 demonstrated a dose-dependent effect on key fibrotic pathways, underscoring its potential as an effective treatment for fibrostenotic Crohn’s disease.

The data will be presented as part of an invited talk titled, "Detailing Characteristics of Fibrostenotic Crohn’s Disease Biology & the Potential of a Local PDE4 Inhibitor Prodrug to Minimize Off-Target Effects & Maximize Efficacy," delivered by Mitch Jones, MD, PhD, Chief Medical Officer of Palisade Bio, at the 8th Annual Antifibrotic Drug Development Summit, being held November 19-21, 2024, in Boston, MA.

“There remains an unmet need in Crohn’s disease, with a number of patients experiencing substantial fibrosis resulting in stenosis at least once in their lifetime, often necessitating surgical intervention,” said Dr. Jones. “Our findings in the DSS mouse model seem to demonstrate that PALI-2108 holds considerable promise as a targeted, dual-action (pleiotropic) anti-inflammatory and anti-fibrotic agent for treating fibrostenotic Crohn’s disease, a condition we believe is inadequately addressed by current therapies. The data seems to indicate that PALI-2108 engages and modulates key fibrotic pathways directly in the intestinal and colonic mucosa, addressing the root cause of fibrosis while minimizing systemic side effects commonly associated with systemic PDE4 inhibitors. This offers what we believe could be a safer and more effective treatment option for patients.”

The study evaluated PALI-2108 in an animal model of inflammatory bowel disease (IBD), often complicated by intestinal fibrosis. PALI-2108, a prodrug activated locally in the ileum and colon, was found to modulate key fibrotic pathways associated with both Crohn’s disease and UC. A comprehensive analysis of gene expression revealed that PALI-2108 affected 187 genes involved in the four main fibrotic pathways of IBD, demonstrating an upregulation and downregulation of key markers. This suggests that PALI-2108 has the potential to reverse or prevent fibrotic progression in the intestines.

The study further revealed that PALI-2108 reduced key intracellular markers of inflammation and fibrosis in the colon, including PDE4B expression, while increasing cAMP levels—a crucial factor in maintaining tissue homeostasis. Notably, the dose-response relationship showed that higher doses of PALI-2108 further enhanced the fibrotic signature, reinforcing its potential as an effective, localized treatment for patients suffering from fibrostenotic Crohn’s disease. The data also seemed to demonstrate that PALI-2108 offers enhanced safety and therapeutic potential compared to traditional treatments. Unlike systemic PDE4 inhibitors, PALI-2108 is designed to be activated locally, reducing the risk of common side effects such as nausea, which are frequently seen with oral PDE4 inhibitors like oral and inhaled roflumilast (AstraZeneca) for fibrotic COPD and oral apremilast (Amgen) and for inflammatory diseases like psoriasis and psoriatic arthritis.

The Company is evaluating PALI-2108 in a Phase 1 single-center, double-blind, placebo-controlled study focused on safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers, alongside an open-label study involving UC patients. Topline data from the Phase 1 study is expected in the first half of 2025. For more information, visit clinicaltrials.gov and reference identifier NCT06663605.

About PALI-2108

PALI-2108 is an orally administered, locally acting colon-specific PDE4 inhibitor prodrug in development for patients affected by UC. The Company recently commenced a Phase 1 single-center, double-blind, placebo-controlled study of PALI-2108 focused on safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers, alongside an open-label study involving a patient cohort with UC. It is anticipated that the comprehensive data gathered will support Palisade Bio’s precision medicine strategy, aimed at identifying patient responders for future clinical studies.

About Palisade Bio 

Palisade Bio is a clinical-stage biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases. The Company believes that by using a targeted approach with its novel therapeutics it will transform the treatment landscape. For more information, please go to www.palisadebio.com.

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