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PALI-2108 is the first and only PDE4 inhibitor in development designed for targeted delivery to the terminal ileum and colon, addressing significant unmet needs in ulcerative colitis (UC) and fibrostenotic Crohn’s disease (FSCD)
Carlsbad, CA, Jan. 07, 2026 (GLOBE NEWSWIRE) --Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”), a clinical-stage biopharmaceutical company developing next-generation, once-daily, oral PDE4 inhibitor prodrugs designed for targeted delivery to the terminal ileum and colon, today announced that the Crohn’s & Colitis Foundation (the “Foundation”), through its IBD Ventures program, has approved a strategic equity investment of up to $500,000 in Palisade. The investment will support the continued clinical and mechanistic development of PALI-2108, the Company’s lead gut-microbiota-activated PDE4 inhibitor, being advanced for fibrostenotic Crohn’s disease (FSCD) and moderate to severe ulcerative colitis (UC).
“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. “This investment represents a strong endorsement of both the scientific rationale underlying PALI-2108 and our targeted, gut-restricted approach to PDE4 inhibition. The Foundation’s support further validates the potential of PALI-2108 to address the significant unmet needs of patients living with UC and FSCD, and we look forward to continuing to advance this program toward the next stages of clinical development.”
“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 Andrés Hurtado Lorenzo, PhD, 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. Through our IBD Ventures program, we invest in promising, differentiated therapies like PALI-2108 to improve patient outcomes and advance innovative approaches for IBD.”
Palisade has completed a Phase 1a single-ascending dose, multiple-ascending dose, and food-effect study of PALI-2108, followed by a Phase 1b cohort study in UC, and is currently evaluating PALI-2108 in an ongoing Phase 1b cohort study in FSCD. Data from these studies are expected to support Phase 2 Investigational New Drug (IND) submissions to the U.S. Food and Drug Administration (FDA) in 2026.
About PALI-2108
PALI-2108 is an orally administered, prodrug engineered for local delivery of phosphodiesterase-4 (PDE4) inhibition to the terminal ileum and colon. The prodrug molecule is gut-restricted and pharmacologically inactive until it reaches the lower intestine, where it is cleaved by bacterial enzymes to release its active PDE4 inhibitor metabolite directly at the site of inflammation and fibrosis. This targeted and slow-release design prevents absorption through the upper gut, achieves sustained local exposure and a longer half-life that enables once-daily dosing, and is engineered to produce a blunted peak plasma concentration to improve the overall therapeutic index. Together, these properties are intended to maximize anti-inflammatory and anti-fibrotic effects while minimizing systemic exposure and reducing class-related tolerability issues, such as nausea and headache, that have limited systemic PDE4 inhibitors.
About the Crohn’s & Colitis Foundation
The Crohn’s & Colitis Foundation is the leading non-profit organization focused on both research and patient support for inflammatory bowel disease (IBD), with the mission of curing Crohn’s disease and ulcerative colitis, and of improving the quality of life of the millions of Americans living with IBD. The Foundation’s work is dramatically accelerating the research process through investment in research initiatives, while also providing extensive educational and support resources for patients and their families, medical professionals, and the public. For more information, visitwww.crohnscolitisfoundation.org, call 888-694-8872, or emailinfo@crohnscolitisfoundation.org.
About Palisade Bio
Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”) is a clinical-stage biopharmaceutical company advancing a next generation of, once daily, oral PDE4 inhibitor prodrugs designed to improve pharmacology, tolerability and convenience for patients with inflammatory and fibrotic diseases. Through its differentiated prodrug platform and precision pharmacology strategy, Palisade Bio is committed to transforming proven PDE4 biology into better, safer oral therapies for patients living with chronic inflammatory and fibrotic diseases.
The Company’s lead program, PALI-2108, is a locally-bioactivated PDE4 inhibitor prodrug being developed for moderate-to-severe Ulcerative Colitis (UC) and fibrostenotic Crohn’s Disease (FSCD), two diseases with limited non-immunosuppressive therapy options. In a recently reported Phase 1b trial, PALI-2108 achieved a 100% clinical response in the UC cohort, with no serious adverse events, favorable tolerability and pharmacokinetics consistent with sustained localized activation, low systemic exposure, and controlled release within the GI tract.
Palisade Bio is now advancing towards a Phase 2 clinical study in UC designed to evaluate clinical remission, response and pharmacodynamic biomarkers over 12 weeks, with an extension phase assessing maintenance of remission. In addition, the Company is preparing to initiate studies in FSCD to further characterize PALI-2108’s safety, pharmacology and therapeutic benefit across inflammatory bowel disease indications. For more information, please go towww.palisadebio.com.
Forward Looking Statements
Any statements contained in this communication that are not statements of historical fact may be deemed to be forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward looking statements include but are not limited to: statements regarding the timing and results of clinical trials, the potential mechanisms of action and therapeutic benefits of PALI-2108, and plans for regulatory submissions. These forward-looking statements are based on the Company’s current expectations. Forward looking statements involve risks and uncertainties. Important factors that could cause actual results to differ materially from those reflected in the Company’s forward looking statements include, among others, the timing of enrollment, commencement and completion of the Company’s clinical trials; the Company’s reliance on PALI-2108, and its early stage of clinical development; the risk that prior results, such as signals of safety, activity, dosing or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving the Company’s product candidates in clinical trials focused on the same or different indications; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 24, 2025, and the Quarterly Reports on Form 10-Q or other SEC filings that are filed thereafter. Investors are cautioned not to put undue reliance on these forward looking statements. These forward looking statements speak only as of the date hereof, and the Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward looking statements contained herein to reflect any change in the Company’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
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