Palisade Bio Provides Update on Progress Toward Launch of Phase 1 Human Clinical Study for Lead Program, PALI-2108 for the Treatment of Ulcerative Colitis

Rhea-AI Summary

Palisade Bio (Nasdaq: PALI) has made significant progress towards launching its Phase 1 human clinical study for PALI-2108, a locally activated PDE4 inhibitor prodrug for treating ulcerative colitis (UC). The company has:

1. Completed nonclinical safety and toxicity studies
2. Finalized Phase 1 clinical trial design
3. Established Maximum Recommended Starting Dose
4. Completed pre-Clinical Trial Application (CTA) meeting with Health Canada
5. Submitted the CTA for the Phase 1 study

The Phase 1 study will be a single-center, double-blind, placebo-controlled study focusing on safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers and UC patients. Palisade Bio plans to enroll approximately 90 patients across various cohorts and remains on track to initiate the study before year-end.

Positive

• Completion of nonclinical safety and toxicity studies for PALI-2108
• Submission of Clinical Trial Application (CTA) for Phase 1 study
• Identification of PDE4B expression as a potential biomarker for patient selection
• Development of six PDE4-related biomarkers for improved patient targeting
• On track to initiate Phase 1 clinical study before year-end

Negative

• None.

Insights

Medical Research Analyst

The progress on PALI-2108 for ulcerative colitis (UC) treatment is promising. Key developments include:

• Completion of nonclinical safety studies and Phase 1 trial design
• Submission of Clinical Trial Application (CTA) to Health Canada
• Innovative patient selection approach using PDE4B expression as a biomarker
• Development of a six-biomarker panel for improved patient targeting

The Phase 1 study design, involving both healthy volunteers and UC patients, aims to assess safety, tolerability and pharmacokinetics. The focus on precision medicine through biomarker-based patient selection could potentially increase efficacy and improve outcomes.

However, investors should note that this is still an early-stage development. While the progress is encouraging, clinical success and regulatory approval are not guaranteed. The company's small market cap of $4.27 million suggests high risk but also potential for significant upside if the drug proves successful in later-stage trials.

Financial Analyst

From a financial perspective, Palisade Bio's progress with PALI-2108 is a positive development, but comes with caveats:

• The advancement to Phase 1 trials indicates potential future value, but commercialization is still years away
• No revenue generation from this product in the near term
• Significant R&D expenses expected as clinical trials progress
• Potential for dilution through future capital raises to fund development

With a market cap of only $4.27 million, Palisade Bio is a micro-cap biotech stock, which typically carries high risk. The company's focus on precision medicine and biomarker-based approach could be a differentiator, potentially increasing the odds of clinical success and future partnering opportunities.

Investors should closely monitor cash burn rate, upcoming milestones and any potential partnerships or licensing deals that could provide non-dilutive funding. The stock is likely to be volatile, reacting strongly to any clinical or regulatory news.

– Completion of nonclinical safety and toxicity studies, Phase 1 clinical trial design and established Maximum Recommended Starting Dose

– Completion of pre- Clinical Trial Application (CTA) meeting with Health Canada

– Submission of the CTA for the Phase 1 clinical study of Normal Healthy Volunteers and ulcerative colitis patients

– On track towards clinical site initiation and dosing of first patient in Phase 1 human clinical study before year end

Carlsbad, CA, Sept. 25, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade,” “Palisade Bio” or the “Company”), a biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, today provided an update on its progress toward the launch of its Phase 1 human clinical study for PALI-2108 for the treatment of ulcerative colitis (UC).

The Company’s lead program, PALI-2108, is a locally activated PDE4 inhibitor prodrug in development for treating patients with moderate to severely active UC. Leveraging advanced machine learning, the Company’s research has identified a measurable threshold of elevated PDE4B expression across more than 1,600 patients and 10 studies, identifying over-expressing patients in over 70% of cases. This finding supports the potential for an FDA-approved test that uses PDE4B expression as a reliable marker for patient enrichment. The Company believes this will lead to better UC patient selection, thereby increasing the efficacy of Palisade’s PDE4-inhibiting prodrug therapeutic. Additionally, the Company is advancing a second approach featuring six PDE4-related biomarkers, which has demonstrated superior performance compared to benchmark tests and is specifically tailored for PDE4 inhibition, providing a targeted solution to improve therapeutic outcomes. The integration of PCR-based assays aimed at potential FDA approval will ensure precision in patient targeting. These developments underscore the Company’s commitment to leading the field of precision medicine for UC, advancing personalized treatment strategies that promise to transform patient care.

“We are excited to announce significant progress in our development of precision medicine tests designed to optimize treatment for moderate to severely active UC patients. We are also pleased with the continued progress of our PALI-2108 program. UC represents a significant challenge for patients who need therapies that provide effective remission rates, are non-immunosuppressive, and have improved safety profiles. Our team continues to execute on the clinical and regulatory steps necessary for the launch of our Phase 1 study and remains confident in our timeline to initiate before year-end,” commented Dr. Mitch Jones, CMO of Palisade Bio.

The Company has submitted a CTA for its Phase 1 study of PALI-2108, which will be a single-center, double-blind, placebo-controlled study focused on safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers, alongside an open-label study involving a patient cohort with UC. As previously announced, the Company has established dose levels and trial design for PALI-2108 and plans to enroll approximately 90 patients across the SAD, FE, MAD and UC cohorts. The primary objective of the study is to assess the safety and tolerability of single (healthy subjects) and repeated (healthy subjects and UC patients) oral doses of PALI-2108. Secondary objectives include determining the plasma, urinary, and fecal (MAD healthy subjects and UC patients only) pharmacokinetics (PK) of PALI 2108 and its metabolites (PALI-0008 and PALI-0708) following PALI-2108 single (healthy subjects) and repeated (healthy subjects and UC patients) oral doses, as well as the effect of food on the PK of PALI-2108 and its metabolites (PALI-0008 and PALI-0708; if applicable) following a single oral dose in healthy subjects.

Additionally, the Company recently held a pre-CTA consultation meeting with Health Canada with the objective of presenting its SAD-MAD-FE Phase 1 program in normal healthy volunteers for PALI-2108. Palisade believes it achieved its objective of understanding Health Canada’s expectations and regulations governing clinical study design, which assisted in the submission of the CTA to commence the Company’s Phase 1 study.

About Palisade Bio 

Palisade Bio is a biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases. The Company believes that by using a targeted approach with its novel therapeutics it will transform the treatment landscape. For more information, please go to www.palisadebio.com.

Forward Looking Statements

This communication contains “forward-looking” statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the extent of our cash runway; our ability to successfully develop our licensed technologies; the timing and outcome of our current and anticipated applications and studies related to our product candidates; estimates about the size and growth potential of the markets for our product candidates, and our ability to serve those markets, including any potential revenue generated; future regulatory, judicial, and legislative changes or developments in the United States (U.S.) and foreign countries and the impact of these changes; our ability to maintain the Nasdaq listing of our securities; our ability to build a commercial infrastructure in the U.S. and other markets; our ability to compete effectively in a competitive industry; our ability to identify and qualify manufacturers to provide API and manufacture drug product; our ability to enter into commercial supply agreements; the success of competing technologies that are or may become available; our ability to attract and retain key scientific or management personnel; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for additional financing; our ability to obtain funding for our operations; our ability to attract collaborators and strategic partnerships; and the impact of the COVID-19 pandemic or any global event on our business, and operations, and supply. Any statements contained in this communication that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements are based upon the Company’s current expectations. Forward-looking statements involve risks and uncertainties. The Company’s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the Company’s ability to advance its nonclinical and clinical programs, the uncertain and time-consuming regulatory approval process; and the Company’s ability to secure additional financing to fund future operations and development of its product candidates. Additional risks and uncertainties can be found in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and most recent Quarterly Report on Form 10-Q for the period ended June 30, 2024, filed with the Securities and Exchange Commission on March 26, 2024 and August 12, 2024, respectively. These forward-looking statements speak only as of the date hereof and the Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

Investor Relations Contact
JTC Team, LLC
Jenene Thomas
908-824-0775
PALI@jtcir.com

FAQ

What is the purpose of Palisade Bio's PALI-2108 clinical trial?

The Phase 1 clinical trial for PALI-2108 aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of the drug in healthy volunteers and patients with ulcerative colitis.

How many patients does Palisade Bio plan to enroll in the PALI-2108 Phase 1 study?

Palisade Bio plans to enroll approximately 90 patients across the SAD, FE, MAD, and UC cohorts in the Phase 1 study for PALI-2108.

What is the potential advantage of PALI-2108 for ulcerative colitis treatment?

PALI-2108 is a locally activated PDE4 inhibitor prodrug that may provide effective remission rates for moderate to severely active ulcerative colitis patients while being non-immunosuppressive and having an improved safety profile.

When does Palisade Bio (PALI) expect to initiate the Phase 1 clinical study for PALI-2108?

Palisade Bio is on track to initiate the Phase 1 clinical study for PALI-2108 before the end of the year (2024).

What biomarker approach is Palisade Bio developing for patient selection in ulcerative colitis treatment?

Palisade Bio is developing two biomarker approaches: one based on PDE4B expression and another featuring six PDE4-related biomarkers, aimed at improving patient selection and therapeutic outcomes in ulcerative colitis treatment.