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CARLSBAD, Calif. - Palisade Bio, Inc. (NASDAQ:PALI), a clinical-stage biotech company with a market capitalization of $5.92 million, announced new clinical data for PALI-2108, its ileocolonic-targeted PDE4 inhibitor being developed for ulcerative colitis (UC) and fibrostenotic Crohn’s disease. According to InvestingPro analysis, the company maintains a strong liquidity position with more cash than debt on its balance sheet.
In a Phase 1b open-label study, all five patients with moderate-to-severe UC who received PALI-2108 for seven days showed clinical response, with an average 62.8% reduction in modified Mayo score. Four of five patients demonstrated decreased fecal calprotectin levels, with a mean reduction of 70%.
The drug also showed histologic improvements across multiple measurement indices, with reductions ranging from 36% to 58%. Tissue analyses confirmed the drug’s mechanism of action through increased cAMP levels in four of five patients and an average 40% decrease in tissue lymphocytes.
In a separate Phase 1a multiple ascending dose study in healthy volunteers, the active metabolite of PALI-2108 remained detectable in colon tissue for at least 36 hours after dosing, supporting the potential for once-daily administration.
The company reported that PALI-2108 was well-tolerated across both studies, with more than 95% of treatment-emergent adverse events rated as mild and transient, primarily consisting of headache and nausea. No serious adverse events were reported.
"The early clinical activity, targeted delivery, dose flexibility, the potential for once-daily oral dosing and its favorable safety profile positions PALI-2108 as a potentially best-in-class oral therapy for patients with UC," said JD Finley, Chief Executive Officer of Palisade Bio, in a press release statement. Analysts appear optimistic about the company’s potential, with price targets ranging from $2 to $16, according to InvestingPro data.
Palisade Bio plans to complete a Phase 1b study in patients with fibrostenotic Crohn’s disease by the second half of 2025 and aims to submit an Investigational New Drug application for Phase 2 studies to the FDA in the first half of 2026. Investors should note that the company’s next earnings report is scheduled for August 8, 2025. For comprehensive financial analysis and additional insights, including 11 more ProTips, visit InvestingPro.
In other recent news, Palisade Bio announced positive results from its Phase 1 studies of PALI-2108, which is being developed to treat fibrostenotic Crohn’s disease and moderate to severe ulcerative colitis. The trials successfully met their primary endpoints of safety, tolerability, and pharmacokinetics, with no serious adverse events reported. Furthermore, the company has secured a patent allowance in China for PALI-2108, providing protection for the composition of matter claims until 2045, subject to regulatory approval timelines. In addition to these developments, Palisade Bio has appointed Emil Chuang to its Board of Directors. Dr. Chuang brings nearly 25 years of experience in the pharmaceutical industry, including leadership roles in drug development programs that achieved regulatory approvals. These recent developments highlight Palisade Bio’s ongoing efforts in advancing its drug pipeline and strengthening its leadership team.
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