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CARLSBAD, CA - Palisade Bio, Inc. (NASDAQ:PALI), a biopharmaceutical company, announced positive topline results from its Phase 1 studies of PALI-2108, aimed at treating fibrostenotic Crohn’s disease (FSCD) and moderate to severe ulcerative colitis (UC). The trials met primary endpoints of safety, tolerability, and pharmacokinetics (PK), with no serious adverse events (SAEs) or treatment-emergent adverse events (TEAEs) related to laboratory values or EKGs noted.
The Phase 1 program included single ascending dose (SAD), multiple ascending dose (MAD), and cross-over food effect (FE) studies in healthy adult volunteers, as well as a small cohort of UC patients. In the SAD study, mild and reversible TEAEs occurred only at the highest dose. The MAD cohorts showed mostly minor TEAEs, and the 15 mg BID dose was free of any TEAEs. Despite the positive clinical developments, InvestingPro analysis shows the company is not yet profitable, with an EBITDA of -$13.49 million in the last twelve months.
Dr. Mitchell Jones, Chief Medical Officer of Palisade Bio, stated, "These data validate PALI-2108’s targeted prodrug design and provide compelling evidence that the drug reaches therapeutic concentrations in the colon with lower systemic exposure." Dr. Gaetano Morelli, Principal Investigator of the Phase 1 study, added that the tissue exposure levels in colon biopsies are encouraging and could reduce risks associated with systemic PDE4 inhibition.
Pharmacokinetic analysis confirmed the delayed-release, targeted profile of PALI-2108, with plasma and tissue PK demonstrating that therapeutically relevant concentrations were achieved in colon tissue up to 24 hours post-dose. Population PK modeling and dose-exposure simulations support a therapeutic window aligned with the safety and tolerability observed in Phase 1, encouraging further clinical development.
Based on these results, Palisade Bio plans to initiate a Phase 1b cohort in FSCD to explore safety, tolerability, and PK/PD, along with chronic safety and toxicology studies. This will be followed by Phase 2 clinical programs to assess the efficacy, safety, and tolerability of PALI-2108 in patients with FSCD and moderate to severe UC. Notably, two analysts have recently revised their earnings expectations upward for the upcoming period, suggesting growing confidence in the company’s development pipeline. For deeper insights into Palisade Bio’s financial health and additional analyst recommendations, investors can access comprehensive analysis through InvestingPro, which offers over 10 additional key insights about the company.
For more information about the Phase 1a/b clinical study, reference identifier NCT06663605 can be found on clinicaltrials.gov. Palisade Bio is dedicated to developing novel therapeutics for autoimmune, inflammatory, and fibrotic diseases. The information in this article is based on a press release statement.
In other recent news, Palisade Bio, Inc. has announced the successful completion of Phase 1a trials for its drug PALI-2108, aimed at treating ulcerative colitis. The trials, which included various dosage cohorts, reported no serious adverse events, indicating a favorable safety profile for the drug. Additionally, Palisade Bio presented promising preclinical data at Digestive Disease Week 2025, showcasing PALI-2108’s potential efficacy in reducing inflammation and improving clinical parameters in ulcerative colitis. The drug demonstrated a dose-dependent reduction in colon tissue PDE4B expression and increased cAMP levels in a mouse model, suggesting its potential to alleviate symptoms. Palisade Bio’s participation at the event highlighted its research’s significance, with PALI-2108’s abstract being recognized among the top 10% for poster presentations. The company is advancing into the Phase 1b study, focusing on safety and tolerability in ulcerative colitis patients, with topline data expected by May 2025. Despite these positive developments, Palisade Bio acknowledges that PALI-2108 remains in early clinical stages and may face challenges such as regulatory approvals and potential side effects. Investors are advised to consider the potential risks and uncertainties associated with the drug’s development.
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