Palisade Bio’s Progress in Phase 1a/b Study of PALI-2108
Palisade Bio's Ongoing Phase 1a/b Study of PALI-2108
Sustained positive preliminary results have emerged from the recent Phase 1a portion of the clinical study focusing on PALI-2108, developed by Palisade Bio, Inc. This investigational drug has shown promise in treating Ulcerative Colitis (UC), with safety and tolerability being primary areas of focus.
Completion of Phase 1a Dosing
Palisade Bio, Inc. (Nasdaq: PALI) has successfully completed all dosing in the Phase 1a single ascending dose (SAD) and multiple ascending dose (MAD) cohorts, as well as a food effects crossover segment. These advancements indicate the company is making significant strides in their research efforts to support UC treatment.
Safety and Tolerability Results
Preliminary data from these cohorts have revealed no serious adverse events (SAEs) or treatment-emergent adverse events (TEAEs) directly linked to the drug. The majority of reported TEAEs have been classified as mild, which further strengthens the potential of PALI-2108 as a viable treatment option. Furthermore, the response to various dosages, specifically from 15 mg to 30 mg twice daily, has been promising, especially with the lowest dosage showing no adverse effects.
Moving to Phase 1b
The transition into the Phase 1b cohort is underway, and initial screenings are progressing as planned. With expectations to unveil topline data in the first half of the year 2025, the company remains focused on ensuring that the advancement of PALI-2108 aligns with their therapeutic vision.
Dr. Mitch Jones' Insights
Dr. Mitch Jones, Chief Medical Officer of Palisade, expressed optimism about the future of PALI-2108. He highlighted the company's dedication to maintaining rigorous standards throughout the study. The ongoing commitment to clinical research reveals their confidence in the drug’s potential to meet significant medical needs. "Our goal is to offer a substantial treatment choice for patients suffering from UC," he noted.
Understanding PALI-2108 and Its Mechanism
The Phase 1a/b study is pivotal for assessing not only how the drug affects healthy individuals but also its safety and efficacy in UC patients. Unlike previously approved PDE4 inhibitors, PALI-2108 is a novel chemical entity that presents unique pharmacokinetics. By rigorously analyzing biomarkers such as serum high-sensitivity C-reactive protein and fecal calprotectin, the study aims to pave the way for a deeper understanding of how PALI-2108 works within the body.
Future Insights and Data Collection
Details derived from biomarker assessments will significantly contribute to comprehending the therapeutic efficacy of PALI-2108 in UC management. The exploration will include analyzing colon tissue to measure drug levels, PDE4 enzyme expression, and various other related biomarkers. These endeavors ensure a comprehensive overview of how the drug can be applicable in clinical settings.
About Palisade Bio
Palisade Bio is driven by a commitment to innovation in developing therapies for autoimmune, inflammatory, and fibrotic diseases. Their strategic approach aims at reshaping treatment paradigms for patients. For those interested in learning more about their mission and ongoing projects, they can find additional resources by visiting the company's website.
Frequently Asked Questions
What is the primary goal of the Phase 1a/b study of PALI-2108?
The primary aim is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PALI-2108 in patients with Ulcerative Colitis.
What were the preliminary safety results of PALI-2108?
Preliminary results indicated no serious adverse events or treatment-emergent adverse events related to the drug.
When can we expect topline data from this study?
The company anticipates reporting topline data from the Phase 1a portion in the first half of 2025.
What unique aspect does PALI-2108 offer compared to existing treatments?
PALI-2108 is a new chemical entity that has not been previously administered to humans, offering novel therapeutic pathways for ulcerative colitis.
How is Palisade Bio approaching patient treatment?
Palisade Bio focuses on utilizing a targeted approach with their therapeutics to transform treatment options for autoimmune and inflammatory diseases.
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