Update on PALI-2108 Phase 1 Clinical Study
– Nonclinical safety and toxicity studies have been completed, and the design for the Phase 1 clinical trial has been finalized, including the establishment of the Maximum Recommended Starting Dose.
– The pre-Clinical Trial Application (CTA) meeting with Health Canada has been successfully completed.
– The CTA for the Phase 1 clinical study, which includes both normal healthy volunteers and ulcerative colitis patients, has been submitted.
– The steps towards launching clinical sites and administering the first dose to a patient in the Phase 1 clinical study are on track for completion before the year's end.
Overview
Palisade Bio, Inc. (NASDAQ: PALI) has recently provided an update that brings exciting news about its lead program, PALI-2108, aimed at treating ulcerative colitis (UC). This biopharmaceutical company is devoted to creating innovative solutions for people dealing with autoimmune, inflammatory, and fibrotic diseases.
The PALI-2108 treatment is a prodrug that acts as a locally activated PDE4 inhibitor, specifically targeting individuals with moderate to severely active UC. Interestingly, this approach employs machine learning to identify a critical level of elevated PDE4B expression among over 1,600 patients drawn from ten different studies. This research has uncovered that more than 70% of these patients demonstrate this over-expression, which presents an opportunity for a potential FDA-approved test. This breakthrough has the potential to help identify the most suitable candidates for the PALI-2108 treatment, ultimately aiming for improved therapeutic effectiveness.
Additionally, Palisade is pursuing a second method that utilizes six PDE4-related biomarkers that have shown better performance than currently available benchmark tests in evaluating PDE4 inhibition. This targeted approach is designed to enhance therapeutic outcomes, illustrating Palisade Bio's dedication to advancing precision medicine in relation to UC.
Significant Progress Announced
Dr. Mitch Jones, Chief Medical Officer at Palisade Bio, shared his thoughts on the significance of these advancements: “We’re thrilled to announce substantial progress in our development of precision medicine tests aimed at optimizing treatment for patients suffering from moderate to severely active UC. The PALI-2108 program is making notable headway, and we’re excited to witness the clinical applications come to life.” He emphasized that UC is a serious challenge, underscoring the urgent need for effective treatments that can achieve remission while ensuring improved safety.
The clinical study for PALI-2108 is structured as a single-center, double-blind, placebo-controlled trial. It will investigate safety, tolerability, pharmacokinetics, and pharmacodynamics among healthy volunteers as well as a group of patients with UC. The expectation is to enroll around 90 participants across various cohorts that will focus on different aspects of the treatment.
Palisade also intends to assess the pharmacokinetics of its metabolites, including PALI-0008 and PALI-0708, exploring how food consumption impacts the pharmacokinetics of PALI-2108 in the process. The primary focus of this study remains on safety and tolerability, two essential factors in the development of new treatments.
Collaboration with Health Authorities
In a proactive step, the company engaged in a pre-CTA consultation meeting with Health Canada. This strategic conversation concentrated on designing the Phase 1 program, which includes normal healthy volunteers. The insights derived from this meeting are anticipated to aid in forming a solid submission of the CTA for PALI-2108.
About Palisade Bio
Palisade Bio is committed to fostering innovation in biopharmaceuticals for individuals affected by autoimmune, inflammatory, and fibrotic diseases. Their targeted therapeutic approach seeks to redefine treatment strategies and enhance patient outcomes. For more information about Palisade Bio’s endeavors and updates, please visit their official website.
Frequently Asked Questions
What is the primary goal of the PALI-2108 study?
The main objective is to assess the safety and tolerability of PALI-2108 in both healthy volunteers and UC patients.
How many patients will be enrolled in the PALI-2108 study?
Approximately 90 patients are expected to be enrolled across various study cohorts.
What conditions does PALI-2108 aim to treat?
PALI-2108 is specifically designed to treat moderate to severely active ulcerative colitis.
What are the unique features of the PALI-2108 treatment?
It is a locally activated PDE4 inhibitor prodrug that employs machine learning for precision medicine.
How does Palisade Bio ensure the effectiveness of its treatments?
The company concentrates on optimizing patient selection and analyzing biomarkers to improve treatment outcomes.
