Palisade Bio Cleared by Health Canada to Commence Phase 1 Clinical Study for Lead Program, PALI-2108 for the Treatment of Ulcerative Colitis (UC)
Rhea-AI Summary
Palisade Bio (Nasdaq: PALI) has received a No Objection Letter from Health Canada for its Phase 1 clinical study of PALI-2108, an oral PDE4 inhibitor prodrug for treating Ulcerative Colitis (UC). The study will evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers and UC patients. The trial design includes Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), and food effects (FE) cohorts, with approximately 90 patients planned for enrollment.
The primary objective is to assess safety and tolerability, with secondary objectives focusing on pharmacokinetics. Exploratory objectives include examining PDE4-related biomarkers and UC-specific markers. Palisade Bio aims to commence site initiation and enrollment before year-end. The company believes PALI-2108 could be the first approved PDE4 inhibitor for UC, addressing a significant medical need in a market expected to reach nearly $10 billion by 2028.
Positive
- Received No Objection Letter from Health Canada for Phase 1 clinical study of PALI-2108
- On track to commence Phase 1 clinical trial before year-end
- PALI-2108 has potential to be the first approved PDE4 inhibitor for Ulcerative Colitis
- Global Ulcerative Colitis market expected to grow to nearly $10 Billion by 2028
Negative
- None.
Insights
This announcement marks a significant milestone for Palisade Bio's PALI-2108 program. Receiving a No Objection Letter from Health Canada for the Phase 1 clinical trial is a important step in the drug development process. The study design, including SAD/MAD components and a UC patient cohort, is comprehensive and will provide valuable data on safety, tolerability and pharmacokinetics.
Key points to consider:
- The global UC market is projected to reach
$10 billion by 2028, indicating substantial market potential. - PALI-2108's unique mechanism as a locally bioactivated PDE4 inhibitor could offer advantages over existing treatments.
- The inclusion of UC patients in the Phase 1 study may provide early efficacy signals.
- The focus on an oral medication addresses an unmet need in UC treatment.
While this news is positive, investors should note that Phase 1 trials primarily assess safety and efficacy data will be The true potential of PALI-2108 will become clearer in later-stage trials.
The development of PALI-2108 addresses a significant unmet need in ulcerative colitis treatment. Current therapies achieve complete remission in less than
Key considerations:
- Local bioactivation in the colon may improve efficacy while reducing systemic side effects.
- Inclusion of biomarkers like hsCRP and fecal calprotectin in the study design will provide valuable insights into the drug's effects on inflammation.
- The Modified Mayo score and histological assessments will offer early indications of clinical benefit.
However, it's important to note that many promising UC treatments have failed in later-stage trials. The true efficacy and safety profile of PALI-2108 will only become clear after more extensive clinical testing.
– Company has received a No Objection Letter from Health Canada in response to submission of its Phase 1 Clinical Trial Application (CTA)
– The study is a Phase 1 Single Ascending Dose (SAD) /Multiple Ascending Dose (MAD) and food effects (FE) and includes multiple dose treatment of UC patients; Global UC market is expected to grow to nearly
Carlsbad, CA, Oct. 10, 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 has received a No Objection Letter from Health Canada for its Phase 1 human clinical study for PALI-2108 for the treatment of UC.
“We are thrilled to receive a No Objection Letter from Health Canada in response to our Clinical Trial Application. This achievement marks the most important milestone to date for our PALI-2108 development program. We continue to believe in the potential of PALI-2108 to be the first approved PDE4 inhibitor for UC and more importantly, provide a much-needed effective and safe solution for UC patients still experiencing significant medical need. Our team remains focused on continuing preparations for the initiation of our Phase 1 clinical trial which is on track to commence before year end,” commented J.D. Finley, Chief Executive Officer.
PALI-2108 is an orally administered PDE4 inhibitor prodrug which 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. 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.
“Patients are actively seeking new and more effective treatment options for their ulcerative colitis. Currently, existing therapies achieve complete remission in fewer than a quarter of patients, and many of the most effective treatments involve injections or carry black box warnings due to serious side effects. A safe and effective oral medication for UC would be highly desirable for the majority of patients,” said Florian Rieder, MD, a member of the Palisade Bio Clinical Advisory Board and Associate Staff in the Department of Gastroenterology, Hepatology, and Nutrition, as well as an Investigator in the Department of Pathobiology at the Cleveland Clinic.
The primary objective of the study will be 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 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 following a single oral dose in healthy subjects. Exploratory objectives will include PDE4-related pharmacodynamic (PD) biomarkers, concentrations of the active form of PALI-2108, high sensitivity C-reactive protein (hsCRP), fecal calprotectin (CalPro), colonic tissue Absolute Lymphocyte Count (ALC), Modified Mayo score, as well as colonic histological changes in UC patients following repeated PALI-2108 oral doses.
Preparations for the clinical study remain ongoing and the Company is on track commence site initiation and enrollment for the study before year end.
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 Phase 1 clinical study for PALI-2108?
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What is the potential market size for Ulcerative Colitis treatments according to Palisade Bio's press release?
