Palisade Bio, Inc. ((PALI)) announced an update on their ongoing clinical study.
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Study Overview: Palisade Bio, Inc. has completed a Phase 1 clinical study titled A Phase 1, Double-Blind, Placebo-Controlled, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of PALI-2108 in Healthy Volunteers and Open-Label Study of a Patient Cohort With Ulcerative Colitis. The study aimed to evaluate the safety, tolerability, and pharmacokinetics of PALI-2108, a novel PDE4 inhibitor prodrug, in both healthy volunteers and ulcerative colitis (UC) patients. This research is significant as it explores a new treatment option for UC, focusing on targeted delivery to the colon to minimize systemic side effects.
Intervention/Treatment: The study tested PALI-2108, an oral PDE4 inhibitor prodrug designed to activate in the colon, thereby reducing potential systemic side effects. The drug aims to manage UC by inhibiting PDE4, a biomarker linked to disease severity.
Study Design: The study was interventional with a randomized, parallel assignment. It was double-blind for healthy volunteers and open-label for UC patients, focusing on treatment as the primary purpose. Participants received either single or multiple doses of PALI-2108 or a placebo, with masking applied to participants, care providers, and investigators.
Study Timeline: The study began on November 5, 2024, and the last update was submitted on August 6, 2025. These dates are crucial as they mark the progression and completion of the study phases, providing a timeline for data collection and analysis.
Market Implications: The completion of this study could positively impact Palisade Bio’s stock performance by positioning PALI-2108 as a promising treatment for UC, potentially differentiating it from existing PDE4 inhibitors. Investors may view this development favorably, especially given the targeted approach that could offer a competitive edge in the UC treatment market.
The study is ongoing, with further details available on the ClinicalTrials portal.
