A New Hope for IBD: Foundation Backs Novel Gut-Targeted Therapy

CARLSBAD, CA – January 07, 2026 – In a significant move that could reshape the treatment landscape for millions suffering from Inflammatory Bowel Disease (IBD), the Crohn’s & Colitis Foundation has made a strategic equity investment of up to $500,000 in Palisade Bio. The funding, channeled through the Foundation's prestigious IBD Ventures program, is set to accelerate the development of PALI-2108, a promising, first-in-class oral drug for ulcerative colitis (UC) and the notoriously difficult-to-treat fibrostenotic Crohn’s disease (FSCD).

This investment serves as a powerful endorsement for Palisade Bio's innovative approach, which aims to deliver a potent anti-inflammatory and anti-fibrotic agent directly to the inflamed gut, potentially sidestepping the debilitating side effects that have plagued similar drugs for decades. For patients facing limited options and the constant threat of surgery, this development represents a new beacon of hope.

A New Paradigm in IBD Treatment

At the heart of this development is PALI-2108, a drug engineered with a revolutionary precision-delivery mechanism. It belongs to a class of drugs known as phosphodiesterase-4 (PDE4) inhibitors, which work by increasing a molecule called cAMP inside cells. Elevated cAMP levels help to suppress inflammation, a key driver of IBD. While the theory is sound, the history of systemic PDE4 inhibitors in IBD is fraught with challenges. Earlier drugs in this class, while effective at reducing inflammation, caused widespread, dose-limiting side effects like severe nausea and headaches, making them intolerable for long-term use in many patients.

Palisade Bio's PALI-2108 is designed to solve this problem. It is a prodrug, meaning it is administered in an inactive form. The cleverness of its design lies in its activation: the drug molecule remains inert as it travels through the stomach and upper gut. Only upon reaching the lower intestine—the terminal ileum and colon, where IBD inflammation is most severe—does it encounter specific bacterial enzymes that cleave the molecule, releasing its active therapeutic payload directly at the site of disease.

This gut-restricted approach is intended to achieve two critical goals: maximize the drug's anti-inflammatory and anti-fibrotic effects where they are needed most and minimize its circulation throughout the rest of the body. By preventing systemic exposure, Palisade believes it can dramatically improve the drug's safety and tolerability profile, finally unlocking the therapeutic potential of PDE4 inhibition for IBD. This dual action is particularly crucial for fibrostenotic Crohn's disease, a complication where chronic inflammation leads to the formation of scar tissue (fibrosis) that narrows the intestines, often requiring surgical intervention. Currently, there are no approved anti-fibrotic therapies for FSCD, representing a massive unmet need.

A Powerful Endorsement from a Leading Advocate

The strategic investment from the Crohn’s & Colitis Foundation is more than just capital; it's a validation of the science from one of the most respected patient and research advocacy organizations in the field. The Foundation's IBD Ventures program is a unique venture philanthropy initiative that funds and advises on the most promising, differentiated therapies with the potential to transform patient lives. The program's rigorous review process involves scientists, clinicians, and patients, ensuring that its investments are directed toward projects with a high likelihood of clinical impact.

“We are honored to receive this strategic equity investment from the Crohn’s & Colitis Foundation through its IBD Ventures program,” said J.D. Finley, Chief Executive Officer of Palisade Bio, in a statement. “This investment represents a strong endorsement of both the scientific rationale underlying PALI-2108 and our targeted, gut-restricted approach to PDE4 inhibition.”

This sentiment was echoed by the Foundation, which highlighted the drug's potential to fill a critical treatment gap.

“We’re excited to be funding and working with Palisade Bio to address major unmet needs in fibrostenotic Crohn’s disease and ulcerative colitis, where patients still face progression to strictures and surgery and limited treatment options,” said Dr. Andrés Hurtado Lorenzo, Senior Vice President of Translational Research and IBD Ventures at the Crohn’s & Colitis Foundation. “PALI-2108 may help meet this need by directly targeting inflammation and fibrosis in the colon and ileum with limited systemic effects.”

Promising Early Data and the Road Ahead

The Foundation's confidence is bolstered by impressive early-stage clinical data. Palisade Bio recently reported results from a Phase 1b study in five patients with moderate-to-severe ulcerative colitis. After just seven days of treatment, the study showed a 100% clinical response rate, with two of the five patients (40%) achieving full clinical remission. Patients experienced a mean reduction of nearly 63% in their disease activity score.

Crucially, the treatment was well-tolerated, with no serious adverse events. The mild, transient side effects observed, such as headache and nausea, were consistent with the PDE4 inhibitor class but appeared manageable, supporting the hypothesis that the gut-restricted design improves the drug's therapeutic index. Histological assessments confirmed a significant reduction in tissue inflammation, and key biomarkers like fecal calprotectin dropped by approximately 70% in most patients.

With this momentum, Palisade Bio is pushing forward. The company is currently evaluating PALI-2108 in an ongoing Phase 1b study for patients with fibrostenotic Crohn's disease. Bolstered by a successful public offering in late 2025 that raised approximately $138 million, the company is well-capitalized to advance its clinical program. Palisade expects the data from these early studies to support Investigational New Drug (IND) submissions to the U.S. Food and Drug Administration (FDA) in the first half of 2026, paving the way for larger, pivotal Phase 2 trials.

For the millions living with the daily burden of IBD, the journey of PALI-2108 represents a tangible source of optimism. The combination of an innovative scientific approach, strong early data, and the backing of a major patient advocacy foundation suggests that a safer, more effective, and convenient oral treatment for ulcerative colitis and Crohn's disease may finally be on the horizon.