Palisade Bio Reports Data Demonstrating PDE4B Expression in Patient Cohorts Could be Utilized as a Potential Marker for Patient Stratification

Rhea-AI Summary

Palisade Bio (Nasdaq: PALI) has reported promising data on PDE4B expression as a potential marker for patient stratification in Ulcerative Colitis (UC) treatment. The company's analysis, conducted in collaboration with Strand Life Sciences, revealed that 70% of adult colitis patients and 90% of pediatric colitis patients show PDE4B expression above a specific threshold. This finding could significantly improve patient selection for targeted therapies.

Palisade is advancing its lead program PALI-2108, an oral colon-specific PDE4 inhibitor prodrug for UC treatment. A Phase 1 clinical study is set to begin before year-end. Preclinical studies in a DSS-induced UC mouse model demonstrated PALI-2108's potential efficacy, showing reduced PDE4B expression, increased cAMP levels, and decreased inflammatory markers with increasing doses.

Positive

• PDE4B expression identified as a potential biomarker for patient stratification in UC treatment
• PALI-2108 shows promising results in preclinical studies for UC treatment
• Phase 1 clinical trial of PALI-2108 on track to start before year-end
• Potential for more personalized and effective UC treatments based on PDE4B expression levels

Negative

• None.

Medical Research Analyst

The data on PDE4B expression in colitis patients is intriguing, potentially offering a new avenue for patient stratification in Ulcerative Colitis (UC) treatment. The 70% identification rate in adults and 90% in pediatric patients with moderate to severe colitis is promising. However, it's important to note that these figures are based on the company's interpretation and require further validation.

The preclinical data from the DSS-induced UC mouse model shows a dose-dependent reduction in PDE4B expression and correlation with inflammatory markers. This suggests PALI-2108 might have a targeted effect on the disease mechanism. Yet, translating animal model success to human trials often faces challenges, so cautious optimism is warranted as we await the Phase 1 results.

Biotech Industry Analyst

Palisade Bio's approach aligns with the growing trend of precision medicine in inflammatory bowel diseases. The potential biomarker-based patient stratification could enhance clinical trial efficiency and, if successful, improve treatment outcomes. However, investors should consider that:

• The company is still pre-clinical, with significant hurdles ahead
• The UC treatment market is highly competitive
• Successful biomarker implementation in clinical practice can be complex

The upcoming Phase 1 trial will be a critical milestone. While the news is positive, it's important to balance the potential with the early stage of development and the inherent risks in biotech R&D.

Curated data show expression of PDE4B above a specific measurable threshold observed in 70% of adult colitis patients and 90% of pediatric colitis patients

Company is advancing lead program PALI-2108, an orally administered, locally acting colon-specific PDE4 inhibitor prodrug in development for patients affected by Ulcerative Colitis (UC)

Phase 1 human clinical study of PALI-2108 for the treatment of UC on track to commence before year end

Carlsbad, CA, Sept. 05, 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 announced the successful completion of refined patient selection strategies based on PDE4-related biomarkers and disease characteristics to optimize clinical outcomes for patients with UC as part of its collaboration with Strand Life Sciences (“Strand”).

As part of the ongoing collaboration with Strand, RNAseq datasets were analyzed using a standardized bioinformatics pipeline, which generates normalized TPM counts for each gene. The analysis found that PDE4B expression is significantly higher in most colitis patients, encompassing both adult and pediatric cohorts. This suggests that PDE4B could be a crucial factor in patient stratification. In adults, a PDE4B over-expression level was determined that the Company believes accurately identifies 70% of moderate to severe cases. In pediatric patients, a PDE4B over-expression level was determined that the Company believes accurately identifies 90% of those with moderate to severe colitis.

“These findings underscore the potential of PDE4B expression as a valuable tool in the precision medicine toolkit for colitis. By tailoring treatment strategies based on PDE4B levels, healthcare providers can offer more personalized and effective interventions for patients suffering from this challenging condition,” commented Dr. Mitch Jones, CMO of Palisade Bio. “PALI-2108 continues to demonstrate promising potential for the treatment of UC, and we look forward to commencing our Phase 1 clinical trial before the end of the year.”

In addition, in a DSS-induced UC mouse model demonstrated increased colon tissue PDE4B levels with induction of DSS colitis and significant reductions in colon tissue PDE4B expression in response to increasing doses of PALI-2108, closely correlated with increasing levels of colon tissue cAMP, and closely correlated to colon tissue inflammatory cytokines such as TNF-alpha. As well, researchers observed a significant reduction in disease activity index score over time compared to the control treated group. Further, body weight loss and changes in colon length were attenuated in increasing dosage groups, showcasing the potential for targeted efficacy.

For more information about PALI-2108 and the Company’s clinical development programs, visit www.palisadebio.com.

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
833-475-8247
PALI@jtcir.com

FAQ

What is the significance of PDE4B expression in Ulcerative Colitis patients according to Palisade Bio's research?

Palisade Bio's research suggests that PDE4B expression could be a important factor in patient stratification for Ulcerative Colitis treatment. The study found that 70% of adult colitis patients and 90% of pediatric colitis patients show PDE4B expression above a specific threshold, potentially allowing for more personalized and effective treatment strategies.

What is PALI-2108 and how is it being developed by Palisade Bio (PALI)?

PALI-2108 is Palisade Bio's lead program, an orally administered, colon-specific PDE4 inhibitor prodrug being developed for the treatment of Ulcerative Colitis. The company is preparing to commence a Phase 1 clinical study of PALI-2108 before the end of the year.

What were the results of the preclinical studies for PALI-2108 in Ulcerative Colitis?

In a DSS-induced UC mouse model, PALI-2108 demonstrated promising results. The studies showed increased colon tissue PDE4B levels with colitis induction, significant reductions in PDE4B expression with increasing doses of PALI-2108, increased colon tissue cAMP levels, reduced inflammatory cytokines, and improvements in disease activity index, body weight loss, and colon length compared to the control group.