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CARLSBAD, CA - Palisade Bio, Inc. (NASDAQ:PALI), a $5.5 million market cap biotech company, announced new clinical data for PALI-2108, its first-in-class, ileocolonic-targeted PDE4 B/D inhibitor being developed for autoimmune, inflammatory, and fibrotic diseases. According to InvestingPro data, the company maintains a healthy balance sheet with more cash than debt, though its stock has seen significant volatility this year.
In Phase 1b testing for ulcerative colitis (UC), all five patients responded to treatment, with two achieving clinical remission after seven days. The study showed a 62.8% mean reduction in modified Mayo score and improvements in histologic measures, including reductions in Nancy Index (58%), Robarts Index (56%), and Geboes Score (36%). Despite these promising results, InvestingPro analysis shows analysts have recently revised their earnings expectations downward, with the company not expected to achieve profitability this year.
The Phase 1a safety study involving 84 participants demonstrated no serious adverse events, laboratory abnormalities, or EKG concerns. The drug was well tolerated at single doses up to 450 mg and multiple twice-daily doses up to 50 mg.
Biomarker analyses revealed normalization of 186 genes linked to fibrosis and Crohn’s disease strictures, supporting potential application in fibrostenotic Crohn’s disease (FSCD).
"The rapid clinical responses and biomarker improvements we observed support PALI-2108’s targeted engagement of PDE4 biology," said Dr. Mitchell Jones, Chief Medical Officer, according to the company’s press release.
PALI-2108 is designed for gut-restricted delivery to maximize therapeutic effects while minimizing systemic exposure and related side effects common with PDE4 inhibitors, such as nausea and headache.
Patient dosing in the Phase 1b FSCD study is expected to begin in the second half of 2025, with Phase 2 IND submissions anticipated in the first half of 2026.
The company plans to prioritize UC as its lead indication while exploring the drug’s potential in FSCD.
In other recent news, Palisade Bio, Inc. has reported positive clinical data for its drug PALI-2108, which is being developed for ulcerative colitis and fibrostenotic Crohn’s disease. In a Phase 1b open-label study, all five patients with moderate-to-severe ulcerative colitis showed a clinical response, with an average 62.8% reduction in the modified Mayo score. Additionally, Palisade Bio has received clearance from Health Canada to conduct a Phase 1b study of PALI-2108 for fibrostenotic Crohn’s disease. The company also announced that China’s National Intellectual Property Administration has issued a Notice of Allowance for a patent covering PALI-2108, which will protect the drug’s composition in China until 2045.
Furthermore, Palisade Bio has adopted a new Phantom Unit Plan, authorizing the grant of up to 10 million cash-settled phantom units to employees, directors, and consultants. In addition to these developments, the company has appointed Emil Chuang to its Board of Directors, who brings extensive pharmaceutical and clinical experience. These updates reflect Palisade Bio’s ongoing efforts in drug development and strategic management initiatives.
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