Core Insights - Palisade Bio announced promising preclinical results for PALI-2108, a local PDE4 inhibitor prodrug, which may enhance efficacy and safety for treating fibrostenotic Crohn's disease compared to traditional therapies [1][3][4] - The data will be presented at the 8th Annual Antifibrotic Drug Development Summit, highlighting the potential of PALI-2108 to minimize off-target effects while maximizing therapeutic efficacy [2] Group 1: PALI-2108 Development - PALI-2108 demonstrated a dose-dependent effect on key fibrotic pathways in a DSS colitis mouse model, indicating its potential as an effective treatment for fibrostenotic Crohn's disease [1][3] - The study revealed that PALI-2108 modulates 187 genes involved in the main fibrotic pathways of inflammatory bowel disease (IBD), suggesting its ability to reverse or prevent fibrotic progression [3][4] Group 2: Mechanism and Safety Profile - PALI-2108 was found to reduce key intracellular markers of inflammation and fibrosis in the colon while increasing cAMP levels, which is crucial for tissue homeostasis [4] - The localized activation of PALI-2108 aims to reduce systemic side effects commonly associated with traditional systemic PDE4 inhibitors, such as nausea [4] Group 3: Clinical Trials and Future Outlook - The company is currently conducting a Phase 1 single-center, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PALI-2108 in healthy volunteers, with topline data expected in the first half of 2025 [5][6] - PALI-2108 is part of the company's precision medicine strategy, aimed at identifying patient responders for future clinical studies [6]

Commenced enrollment and dosing in Phase 1 clinical study of PALI-2108 for the treatment of moderate-to-severe Ulcerative Colitis (UC) Carlsbad, CA, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade,” “Palisade Bio” or the “Company”), a clinical-stage biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, today reported its financial results for the third quarter of 2024 and provi ...

Targeted, better-tolerated oral PDE4 inhibitors are an unmet need in inflammatory bowel disease (IBD) PALI-2108 demonstrates in ex vivo studies; targeted activation and reduced side effects, potentially enhancing patient compliance compared to existing PDE4 inhibitors Data presented at the American College of Gastroenterology’s (ACG) 2024 Annual Scientific Meeting Carlsbad, CA, Oct. 31, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade,” “Palisade Bio” or the “Company”), a biopharmaceuti ...

Core Viewpoint - Palisade Bio has received a No Objection Letter from Health Canada for its Phase 1 Clinical Trial Application for PALI-2108, a potential treatment for ulcerative colitis (UC), which is expected to grow to nearly $10 billion by 2028 [1][2]. Company Summary - Palisade Bio is a biopharmaceutical company focused on developing novel therapeutics for autoimmune, inflammatory, and fibrotic diseases [7]. - The company aims to transform the treatment landscape with its targeted approach [7]. Clinical Trial Details - The Phase 1 study for PALI-2108 will evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers and UC patients, with approximately 90 patients to be enrolled [3][5]. - The study design includes a single-center, double-blind, placebo-controlled format for healthy subjects and an open-label study for UC patients [3]. - The primary objective is to assess the safety and tolerability of single and repeated oral doses of PALI-2108, while secondary objectives will focus on pharmacokinetics and the effect of food on drug absorption [5]. Market Need - There is a significant medical need for effective treatments for UC, as current therapies achieve complete remission in fewer than 25% of patients, and many effective treatments involve injections or have serious side effects [4]. - A safe and effective oral medication for UC would be highly desirable for the majority of patients [4]. Future Plans - The company is on track to commence site initiation and enrollment for the clinical study before the end of the year [6].

– Continued progress toward commencement of Phase 1 human clinical study of lead product candidate, PALI2108, for the treatment of Ulcerative Colitis (UC) before year end – Company continues to establish growing body of preclinical data for PALI-2108 and global patent estate – Sufficient cash on hand to execute on current business plan and reach clinical and regulatory milestones through first quarter of 2025 Carlsbad, CA, Aug. 13, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) ("Palisade", "Pal ...

– Phase 1 human clinical study of PALI-2108 for the treatment of Ulcerative Colitis (UC) on track to commence before year end – Based on the modeling and simulations, Palisade has established dose levels and trial design for PALI-2108 Carlsbad, CA, Aug. 08, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) ("Palisade", "Palisade Bio" or the "Company"), a biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic d ...

Mitch Jones, MD, PhD, CMO of Palisade Bio highlights recent findings from a microbiome study confirming local bioactivation of lead product candidate, PALI-2108 Carlsbad, CA, July 31, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (the "Company"), a biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, today announced the release of a Virtual Investor "What This Means" segment. As part of this "W ...

Carlsbad, CA, July 31, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (NASDAQ:PALI) (the "Company"), a biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, today announced the release of a Virtual Investor "What This Means" segment. About Palisade Bio JTC Team, LLC Jenene Thomas 833-475-8247 PALI@jtcir.com Mitch Jones, MD, PhD, CMO of Palisade Bio highlights recent findings from a microbiome study confirming l ...

Findings demonstrate that the microbiome and enzymes are sufficient in mouse, dog, and Normal Healthy Volunteers (NHV) and Ulcerative Colitis (UC) patients Carlsbad, CA, July 29, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (NASDAQ:PALI) (the "Company"), a biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, today announced the successful completion of a microbiome study demonstrating that beta-glucuronidase ...

This patent family provides Composition of Matter coverage beyond 2042 PALI-1908 is in development to treat patients with active fibro stenotic Crohn's Disease (CD) J.D. Finley, Chief Executive Officer of Palisade commented, "We are pleased to further expand our global patent estate for our PALI-2108 and PALI-1908 programs with this European patent. PALI-2108 continues to demonstrate encouraging data and bolster our confidence in its potential as a next-generation therapeutic option for patients with inflam ...