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Palisade Bio, Inc. (Symbol: PALI) is a clinical-stage biopharmaceutical company dedicated to developing therapeutic solutions aimed at preserving the integrity of the intestinal barrier. The company's primary focus is on innovative treatments for inflammatory bowel diseases (IBD) such as ulcerative colitis (UC) and Crohn's disease (CD).
Palisade Bio’s strategic product portfolio includes PALI-2108, a promising drug candidate currently under development for treating IBD conditions. The company is also actively researching PALI-1908, a potential therapeutic that may expand its impact in gastrointestinal health.
Recently, Palisade Bio announced significant progress in its pipeline and secured strategic partnerships to further its research and development efforts. Notably, Ladenburg Thalmann & Co. Inc. is acting as the exclusive placement agent for the latest offering, underscoring the financial community's confidence in the company's vision and potential.
Palisade Bio's commitment to advancing healthcare solutions is backed by a robust team and dedicated research initiatives. The company frequently updates its stakeholders with the latest developments and forward-looking statements. For more information or inquiries, Jenene Thomas from the JTC Team, LLC can be contacted at 833-475-8247 or via email at PALI@jtcir.com.
Palisade Bio (Nasdaq: PALI) has announced progress in developing PALI-2108, its lead drug candidate for Ulcerative Colitis (UC). The company has determined the Maximum Recommended Starting Dose (MRSD) for human trials using comprehensive scaling approaches and modeling. Key findings from pharmacokinetic (PK) modeling and simulations indicate that dosing regimens with minimal accumulation are both safe and within the doses showing maximal efficacy in animal models. Palisade Bio has established dose levels and trial design for PALI-2108, an orally administered, colon-specific PDE4 inhibitor prodrug. The upcoming Phase 1 clinical trial, set to commence before year-end, will evaluate safety, tolerability, and PK in healthy volunteers and UC patients, as well as pharmacodynamics in UC patients.
Palisade Bio (Nasdaq: PALI) has released a Virtual Investor 'What This Means' segment featuring Chief Medical Officer Mitchell Jones, MD, PhD. The segment focuses on the company's recent microbiome study that confirmed bacterial enzymes for local bioactivation of their lead product candidate, PALI-2108. This development is significant for Palisade Bio's planned Phase 1 human clinical study for the treatment of Ulcerative Colitis.
The company, which specializes in developing therapeutics for autoimmune, inflammatory, and fibrotic diseases, views this as an important step forward in their research. The Virtual Investor segment is now available online, providing investors and interested parties with insights into the implications of this study for Palisade Bio's future clinical trials and potential treatment options.
Palisade Bio (Nasdaq: PALI) has successfully completed a microbiome study for its lead product candidate, PALI-2108, aimed at treating Ulcerative Colitis (UC). The study confirmed that beta-glucuronidase, an enzyme important for the bioactivation of PALI-2108, is present at similar levels in mouse, dog, and human microbiota, including healthy humans and those with Crohn's disease and UC.
Key findings include:
- Beta-glucuronidase presence is not significantly different among species or between healthy and diseased human cohorts
- The study supports previous findings of adequate bioactivation of PALI-2108 in Normal Healthy Volunteers and UC patients' stool
- Palisade Bio is advancing towards a Phase 1 clinical study of PALI-2108 for UC treatment, expected to begin before the end of 2024
Palisade Bio (Nasdaq: PALI) announced that the European Patent Office has issued a decision to grant notice for patent number 4,157,853, titled 'Gut Microbiota Bioactivated PDE4 Inhibitor Precursors.' This patent, expected to be issued on July 31, 2024, includes composition of matter claims for PALI-2108 and PALI-1908, providing coverage beyond 2042. PALI-2108 is being developed for moderate-to-severe Ulcerative Colitis, while PALI-1908 targets fibro stenotic Crohn's Disease.
The patent claims cover PALI-2108's proprietary composition, designed as an orally administered, colon-specific PDE4 inhibitor prodrug. Its unique galactose-derived sugar moiety allows for minimal absorption until cleaved by colonic bacteria, ensuring localized bioactivation. Palisade Bio plans to initiate a Phase 1 clinical study for PALI-2108 before the end of 2024.
Palisade Bio announced the successful completion of the first GMP manufacturing batch of its drug substance PALI-2108, targeted for treating moderate-to-severe ulcerative colitis (UC).
The company partnered with Eurofins for process development and scale-up. The drug substance has been utilized in completed murine and non-murine GLP toxicology studies and will be used in an upcoming Phase 1 clinical study set to start before the end of the year.
Palisade Bio also completed manufacturing and testing of enteric-coated tablets of PALI-2108, ensuring reliable drug release profiles. In a DSS-induced UC mouse model, significant reductions in disease activity index and body weight loss were observed, indicating promising efficacy.
CEO J.D. Finley emphasized the importance of this milestone in advancing effective therapies for UC patients and expressed optimism about the upcoming clinical trial data.
Palisade Bio (Nasdaq: PALI) will participate in the Virtual Investor Closing Bell Series on Wednesday, June 26, 2024, at 4:00 PM ET. The event will feature J.D. Finley, CEO, and Dr. Mitch Jones, CMO, who will provide a corporate overview and business outlook. Investors can submit questions live during the session. The live webcast will be available on the Events page of Palisade Bio's website, with a replay accessible two hours after the event for 90 days.
Palisade Bio has provided an update on its strategic collaboration with Strand Life Sciences, focusing on advancing precision medicine for ulcerative colitis (UC). Through extensive analysis of transcriptomics datasets and clinical biomarkers, the collaboration has identified promising PDE4-related biomarkers associated with UC pathology. This progress paves the way for targeted therapeutic interventions.
Key areas of progress include the identification of candidate predictive biomarkers, the refinement of patient selection strategies based on these biomarkers and disease characteristics, and the integration of clinical biomarkers with disease activity measures to develop personalized UC therapies. Dr. Mitch Jones, CMO, and CEO JD Finley emphasized the commitment to innovation and the goal of becoming a leader in precision medicine for inflammatory and fibrotic diseases.
Palisade Bio announced a Notice of Allowance from the Canadian Intellectual Property Office for a patent covering their lead product candidate, PALI-2108. This patent protects the composition of PALI-2108, an orally administered, colon-specific PDE4 inhibitor prodrug, under development for treating Ulcerative Colitis (UC). In preclinical studies, PALI-2108 demonstrated promising results, reducing disease activity and body weight loss in a UC mouse model. The company plans to commence a Phase 1 human clinical study of PALI-2108 by the end of 2024.
Palisade Bio (Nasdaq: PALI), a biopharmaceutical company, is set to present at the Virtual Investor Pitch Conference on June 17, 2024, at 12:00 PM ET. J.D. Finley, the CEO, will deliver an 'elevator pitch' and outline the company's forthcoming milestones. The event offers investors and interested parties the chance to submit live questions. A live video webcast will be available on the company's website, with a replay accessible for 90 days post-event.
Palisade Bio's lead product, PALI-2108, has shown promising preclinical results for treating Ulcerative Colitis (UC).
Presented at Digestive Disease Week 2024, data indicates that PALI-2108, an orally administered, colon-specific PDE4 inhibitor, is safe, effective, and well-tolerated in mouse models.
It achieved comparable efficacy to apremilast doses, which are intolerable for human use.
Furthermore, PALI-2108 demonstrated significant improvements in disease activity markers and prevented colon length reduction in a dose-dependent manner.
Notably, it exhibited a large therapeutic window and no systemic toxicity in dog models.
The company plans to commence Phase 1 human trials by year-end 2024.
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