Palisade Bio Shares Encouraging Phase 1a Results for PALI-2108
The Phase 1 studies for PALI-2108 highlighted safety, tolerability, and pharmacokinetics.
No serious adverse events were found during testing across participant cohorts.
Encouraging Results Announced
Palisade Bio, Inc. (NASDAQ: PALI) has disclosed promising topline results from its Phase 1 studies concerning PALI-2108, a revolutionary PDE4 B/D inhibitor aimed primarily at treating fibrostenotic Crohn's disease and moderate to severe ulcerative colitis. This clinical-stage biopharmaceutical company is dedicated to innovating treatments for patients with autoimmune, inflammatory, and fibrotic conditions.
The Phase 1 program incorporated single ascending dose (SAD), multiple ascending dose (MAD), and food effect studies involving both healthy adult volunteers and a select group of patients suffering from ulcerative colitis. Importantly, the trials met their main goals, focusing on safety, tolerability, and pharmacokinetics, providing a substantial foundation for advancement into Phase 2 trials.
Dr. Mitchell Jones, Chief Medical Officer of Palisade Bio, expressed optimism regarding the data, stating, “These results affirm PALI-2108’s targeted prodrug design and show that it achieves therapeutic levels in the colon while minimizing systemic exposure.” Such findings, coupled with existing nonclinical pharmacokinetic data, bolster confidence in advancing PALI-2108 into more extensive patient trials.
Key Findings from Phase 1 Studies
Safety and Tolerability Metrics
- Safety & Tolerability:
- No serious adverse events were recorded across the various participant cohorts during the studies.
- During the SAD study, which ranged from 15 to 450 mg, only mild and reversible treatment-emergent adverse events were noted.
- The MAD cohorts yielded mostly minor adverse events, with only a moderate incident at the 50 mg BID dosing, resulting in withdrawal. The 15 mg BID group demonstrated no adverse events at all.
- Pharmacokinetics Highlights:
- Pharmacokinetic analysis confirmed that PALI-2108 exhibits a targeted, delayed-release profile tailored for the terminal ileum and colon.
- Drug concentrations relevant to therapeutic purposes were established in colon tissues, notably persisting for up to 24 hours following administration.
- Proving its localized action, the drug showed low systemic exposure, with plasma-to-tissue ratios affirming its effectiveness in the distal gut.
- Dosing and Modeling Insights:
- Population pharmacokinetic modeling supported a therapeutic window corresponding to the safety and tolerability observed, fostering further dose exploration.
- This modeling is expected to guide future clinical trials in determining effective dosing strategies.
Dr. Gaetano Morelli, Principal Investigator for the study, highlighted the significance of the pharmacokinetic data, noting that the levels of drug exposure were encouraging, especially concerning tissue samples from colon biopsies.
Prospectively, Palisade Bio intends to expand the Phase 1 program with a safety and tolerability cohort focusing on PALI-2108, aiming for a Phase 2 study to evaluate its efficacy in treating fibrostenotic Crohn's disease and ulcerative colitis.
Company Impact and Future Aspirations
As Palisade Bio advances its drug development efforts, insights from the Phase 1 studies are viewed as a critical component in the evolution of treatment options for patients grappling with these challenging diseases. The organization’s commitment to innovative therapeutic approaches could mitigate existing treatment gaps in this patient population.
Moreover, the results of the Phase 1 studies lay a promising groundwork for broader clinical applications, with plans to meticulously explore optimal dosing regimens while simultaneously assessing long-term safety and toxicity.
About Palisade Bio
Palisade Bio stands at the forefront of biopharmaceutical innovation, aiming to advance novel therapies that align with the requirements of patients facing chronic and complex conditions. The Company’s drive towards targeted treatment regimens is set to significantly influence the therapeutic landscape.
For inquiries regarding the clinical study and further details, please feel free to contact:
JTC Team, LLC
Jenene Thomas
908-824-0775
PALI@jtcir.com
Frequently Asked Questions
What is PALI-2108?
PALI-2108 is a novel phosphodiesterase-4 B/D inhibitor developed for treating fibrostenotic Crohn’s disease and ulcerative colitis.
What were the results of the Phase 1 studies?
The Phase 1 studies demonstrated positive topline results concerning safety, tolerability, and pharmacokinetics, with no serious adverse events noted.
How does PALI-2108 work?
PALI-2108 targets the terminal ileum and colon to minimize systemic exposure while achieving therapeutic concentrations locally.
What are the next steps for Palisade Bio?
Palisade Bio plans to initiate a Phase 1b cohort for further safety and PK exploration before progressing to Phase 2 clinical studies.
Where can I find more information about Palisade Bio?
More details about the company and its research can be found on their official website and clinical trials page.
