CARLSBAD, CA - Palisade Bio, Inc. (NASDAQ:PALI), a biopharmaceutical company, has presented promising preclinical data on its lead product candidate PALI-2108, a novel treatment for ulcerative colitis (UC). The findings were showcased at Digestive Disease Week (DDW) 2024, which concluded today in Washington, D.C.
PALI-2108 is an orally administered, colon-specific Phosphodiesterase-4 (PDE4) inhibitor prodrug. It has been designed to exert its effects locally in the colon with minimal systemic exposure, potentially reducing side effects. Preclinical trials have shown that PALI-2108 is safe, effective, and well-tolerated.
The study presented at DDW demonstrated that PALI-2108 binds effectively to PDE4 in the colon and exhibits dose-dependent efficacy in two DSS colitis mouse models. Notably, it achieved comparable efficacy to higher doses of the PDE4 inhibitor apremilast, which are considered intolerable for human use in UC patients.
In the preclinical study, mice with induced acute colitis were treated with PALI-2108, resulting in significant improvements in body weight, stool consistency, fecal blood scores, and overall disease activity index (DAI). Moreover, a single oral dose of PALI-2108 in dogs showed no systemic toxicity and prevented emesis, suggesting a large therapeutic window due to its local activation.
Dr. Mitch Jones, Chief Medical Officer of Palisade Bio, commented on the preclinical data, expressing confidence in PALI-2108's potential as a treatment for UC. The company aims to initiate a Phase 1 human clinical study of PALI-2108 before the end of the year.
This development is part of Palisade Bio's broader commitment to developing therapies for patients with autoimmune, inflammatory, and fibrotic diseases. While the company has expressed optimism about PALI-2108's potential, these statements are forward-looking and subject to the uncertainties of the regulatory approval process and clinical trial outcomes.
The information presented in this article is based on a press release statement from Palisade Bio. Investors and stakeholders are advised to follow the progress of PALI-2108 through subsequent clinical trials to determine its safety and efficacy in humans.
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