Palisade Bio Announces Preliminary Data from Phase 1 Clinical Study of PALI-2108 for the Treatment of Moderate-to-Severe Ulcerative Colitis Appears to be Safe and Well Tolerated in Treated Subjects

Rhea-AI Summary

Palisade Bio (NASDAQ: PALI) announced preliminary results from its Phase 1 clinical study of PALI-2108 for treating moderate-to-severe Ulcerative Colitis. The first three single ascending dose (SAD) cohorts demonstrated promising safety results with no treatment-related adverse events. The study included 24 subjects (6:2 active to placebo ratio) at doses of 15mg, 50mg, and 150mg. Preliminary pharmacokinetic data showed delayed release of the PDE4 inhibitor active, suggesting successful colonic bioactivation. The company plans to proceed with a food effect crossover study, multiple ascending dose cohorts, and a UC patient cohort. Topline data is expected in first half of 2025.

Positive

• Preliminary safety data shows no treatment-related adverse events (TRAEs) or serious adverse events (SAEs)
• Successfully completed three dose cohorts with positive safety profile
• Pharmacokinetic data indicates drug is performing as designed with colonic bioactivation

Negative

• Study is still in early Phase 1 stage with final results not expected until H1 2025
• No efficacy data available yet as current results focus only on safety

Insights

Medical Research Analyst

The preliminary Phase 1 data for PALI-2108 demonstrates encouraging safety results in treating Ulcerative Colitis. The study's design, incorporating three Single Ascending Dose cohorts (15mg, 50mg and 150mg) with 24 subjects, showed no Treatment Related Adverse Events or serious safety concerns. The PK data suggests successful colonic bioactivation, validating the drug's designed mechanism of action.

The progression to food effect studies and Multiple Ascending Dose cohorts represents standard clinical development. The inclusion of biomarkers like hsCRP and fecal calprotectin, along with tissue analysis, will provide important efficacy signals. For a micro-cap company ($3.6M market cap), completing these early safety milestones is significant, though substantial funding will be needed for later-stage development.

First three Single Ascending Dose cohorts demonstrated no treatment related adverse events

Carlsbad, CA, Dec. 03, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc, (Nasdaq: PALI) (“Palisade,” “Palisade Bio” or the “Company”), a clinical-stage biopharmaceutical company focused on developing novel therapeutics for autoimmune, inflammatory, and fibrotic diseases, today announced preliminary results from its first three single ascending dose (SAD) cohorts in its ongoing Phase 1 human clinical study for PALI-2108 for the treatment of Ulcerative Colitis (UC).

The ongoing Phase 1 study is evaluating PALI-2108 in a single-center, double-blind, placebo-controlled study focused on safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in healthy volunteers, alongside an open-label study involving a patient cohort with UC.

Preliminary results appear to indicate that PALI-2108 was safe and well tolerated in the first three cohorts (n=24; 6:2 active to placebo) at 15mg, 50mg, and 150mg, with no treatment related dose reductions, no Treatment Related Adverse Events (TRAEs), no Serious Adverse Events (SAEs), and no treatment related lab abnormalities in any subject. Preliminary PK data from the first cohorts demonstrated delayed release of the PDE4 inhibitor active suggesting PALI-2108 is performing as designed with colonic bioactivation. Based on the findings with this preliminary safety data, the Company is advancing towards its planned crossover study to evaluate the effects of food on PK, followed by multiple ascending dose (MAD) cohorts, and finally a multiple dose cohort of patients with UC. Comprehensive safety monitoring and similar PK evaluations will be conducted in this cohort.

The primary aim of this single-center Phase 1 study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of PALI-2108 in healthy volunteers as well as to evaluate the safety, tolerability, and PK, and pharmacodynamics PD in patients with UC. Several PDE4 inhibitors have received market approval in both inflammatory and fibrotic disease; however, PALI-2108 represents a new chemical entity that has not been previously administered to humans. Biomarkers, including serum high sensitivity C-reactive protein (hsCRP), and fecal calprotectin (CalPro), along with colonic tissue histological assessments, will be employed to provide further insights into the drug’s effects. The analysis of colon tissue will include the study drug and metabolite levels, PDE4 expression, cyclic adenosine monophosphate (cAMP) levels, Absolute Lymphocyte Count (ALC), and related PD biomarkers, which are crucial for understanding the drug’s mechanism and efficacy.

The Company is on track to report topline data from this study in the first half of 2025.

For more information about the Phase 1 clinical study, visit clinicaltrials.gov and reference identifier NCT06663605.

About PALI-2108

PALI-2108 is an orally administered, locally acting colon-specific PDE4 inhibitor prodrug in development for patients affected by UC. It is anticipated that the comprehensive data gathered will support Palisade Bio’s precision medicine strategy, aimed at identifying patient responders for future clinical studies.

About Palisade Bio 

Palisade Bio is a clinical-stage 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 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, filed with the Securities and Exchange Commission (“SEC”) on March 26, 2024, and the Quarterly Reports on Form 10-Q or other SEC filings that are filed thereafter. 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 are the preliminary results of PALI-2108 Phase 1 trial for Ulcerative Colitis?

The preliminary results show PALI-2108 was safe and well-tolerated in the first three cohorts (n=24) at 15mg, 50mg, and 150mg doses, with no treatment-related adverse events or serious adverse events reported.

When will Palisade Bio (PALI) report topline data for PALI-2108 Phase 1 trial?

Palisade Bio expects to report topline data from the PALI-2108 Phase 1 clinical study in the first half of 2025.

What are the next steps in PALI-2108's clinical development?

The next steps include conducting a food effect crossover study, followed by multiple ascending dose (MAD) cohorts, and finally a multiple dose cohort study in patients with Ulcerative Colitis.