Palisade Bio Announces First Subject Dosed in Phase 1 Clinical Study of PALI-2108 for the Treatment of Moderate-to-Severe Ulcerative Colitis (UC)

Rhea-AI Summary

Palisade Bio (NASDAQ: PALI) has initiated its Phase 1 clinical study of PALI-2108, dosing its first subject. The study evaluates an orally administered PDE4 inhibitor prodrug for treating moderate-to-severe Ulcerative Colitis (UC). The single-center, double-blind, placebo-controlled study will assess safety, tolerability, pharmacokinetics, and pharmacodynamics in both healthy volunteers and UC patients. The study includes single ascending dose (SAD) cohorts, food effect evaluation, multiple ascending dose (MAD) cohorts, and a UC patient cohort. Topline data is expected in first half of 2025.

Positive

• First subject dosed in Phase 1 clinical trial, marking transition to clinical stage company
• Comprehensive study design including both healthy volunteers and UC patients
• Clear timeline for topline data release in H1 2025

Negative

• PALI-2108 is a new chemical entity never tested in humans before, increasing development risk

Insights

Medical Research Analyst

The initiation of Phase 1 clinical trials for PALI-2108 represents a significant milestone for Palisade Bio. The study's comprehensive design, incorporating both healthy volunteers and UC patients, will provide important safety and efficacy data for this novel PDE4 inhibitor prodrug. The trial's focus on local bioactivation in the colon is particularly noteworthy, as it may potentially reduce systemic side effects common to other PDE4 inhibitors.

The inclusion of multiple biomarkers (hsCRP, CalPro) and tissue analysis will provide valuable mechanistic insights. The MAD and SAD cohorts, combined with food effect studies, will establish a thorough pharmacological profile. While this is an early-stage trial, the established success of other PDE4 inhibitors in inflammatory conditions provides a promising backdrop for PALI-2108's development. However, investors should note that topline data expected in H1 2025 means significant time before potential commercialization.

Carlsbad, CA, Nov. 07, 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 that it dosed its first subject in its Phase 1 clinical study of PALI-2108, an orally administered PDE4 inhibitor prodrug that is locally bioactivated in the colon and is in development for patients affected by UC.

The Phase 1 study will evaluate PALI-2108 in 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. Patient screening for the study is underway.

“The dosing of our first subject marks an important milestone as Palisade transitions to a clinical stage company. We anticipate releasing topline data during the first half of 2025,” commented JD Finley, Chief Executive Officer of Palisade Bio.

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 pharmacokinetics (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. The study will consist of single ascending dose (SAD) cohorts followed by a 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. 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.

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

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 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 Phase 1 trial for PALI-2108?

The Phase 1 trial aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PALI-2108 in both healthy volunteers and patients with Ulcerative Colitis.

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

Palisade Bio expects to release topline data for the PALI-2108 Phase 1 trial during the first half of 2025.

What biomarkers will be measured in Palisade Bio's PALI-2108 Phase 1 trial?

The trial will measure serum high sensitivity C-reactive protein (hsCRP), fecal calprotectin (CalPro), and conduct colonic tissue histological assessments, along with PDE4 expression and cAMP levels.