Palisade Bio Announces Notice of Allowance for Canadian Patent Covering Lead Product Candidate, PALI-2108
Palisade Bio announced a Notice of Allowance from the Canadian Intellectual Property Office for a patent covering their lead product candidate, PALI-2108. This patent protects the composition of PALI-2108, an orally administered, colon-specific PDE4 inhibitor prodrug, under development for treating Ulcerative Colitis (UC). In preclinical studies, PALI-2108 demonstrated promising results, reducing disease activity and body weight loss in a UC mouse model. The company plans to commence a Phase 1 human clinical study of PALI-2108 by the end of 2024.
- Notice of Allowance for Canadian patent strengthens intellectual property portfolio.
- PALI-2108 exhibited promising preclinical results in UC mouse model.
- Significant reduction in disease activity index (DAI) score observed.
- Patent covers proprietary composition ensuring competitive advantage.
- Plans to start Phase 1 human clinical study by end of 2024.
- Potential for PALI-2108 to be the first approved PDE4 inhibitor for UC.
- to preclinical study data; human trials yet to commence.
- Future clinical trials may present unforeseen challenges or adverse effects.
- No revenue from PALI-2108 until successful completion of clinical trials and regulatory approvals.
Insights
Palisade Bio's recent announcement about the Notice of Allowance for a Canadian patent for PALI-2108 is a positive step in advancing their intellectual property portfolio. The compound’s unique formulation, designed for colon-specific action with minimal systemic exposure, leveraged by the targeted cleavage via colonic bacterium enzyme β-glucuronidase, is particularly noteworthy.
From a medical research perspective, the preclinical results are promising. In the DSS-induced UC mouse model, PALI-2108 showed a significant reduction in the Disease Activity Index (DAI) score and minimized body weight loss in specific dosage groups. This indicates potential efficacy in treating Ulcerative Colitis (UC), which remains a challenging condition due to limited effective therapeutic options.
However, while preclinical results are encouraging, the transition to human clinical trials often poses significant challenges. The upcoming Phase 1 clinical study will be important in validating these findings in human subjects, focusing on safety, tolerability and initial signs of efficacy. Investors should keep an eye on the results of these trials, as they will provide more concrete evidence of the drug's potential.
The granting of a Notice of Allowance for a Canadian patent for PALI-2108 adds value to Palisade Bio’s intellectual property assets and potentially strengthens their market position. This move could enhance investor confidence and attract interest from potential partners or acquirers, particularly those focused on autoimmune and inflammatory diseases.
From a financial perspective, the initiation of the Phase 1 clinical study before the end of the year is a significant milestone that could act as a catalyst for the company's stock price. Success in these trials could open doors to advanced stages of clinical development, leading to higher valuation. Nevertheless, investors should consider the financial implications of continued R&D expenditures, which may increase in the short term as the company advances the clinical trials.
Moreover, the unique formulation of PALI-2108 could potentially allow for premium pricing if approved, given the current unmet needs in the UC treatment landscape. Yet, it is essential to monitor the competitive dynamics within the UC market, including any new entrants or breakthroughs that could impact PALI-2108's market potential.
PALI-2108 is orally delivered and colon-specific allowing for local activity with low systemic exposure
Company on track to commence Phase 1 human clinical study of PALI-2108 for the treatment of UC before year end
Carlsbad, CA, June 11, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”), biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, today announced that the Canadian Intellectual Property Office (CIPO) has issued a Notice of Allowance for patent application number 3,174,137 titled, “Gut Microbiota Bioactivated PDE4 Inhibitor Precursors.” This patent covers the composition of PALI-2108, the Company’s orally administered, locally acting colon-specific Phosphodiesterase-4 (PDE4) inhibitor prodrug in development for patients affected by Ulcerative Colitis (UC).
J.D. Finley, Chief Executive Officer of Palisade commented, “We remain committed to strengthening the intellectual property portfolio around PALI-2108 and are pleased to bolster our patent estate with this allowed Canadian patent. Importantly, this is the first patent notice of allowance for the composition of matter for PALI-2108 and enables us to establish and build upon a patent family in many geographies. Based on the data demonstrated to date, we believe PALI-2108 has the potential to be the first approved PDE4 inhibitor for UC and underscores its potential as a next-generation therapeutic option for patients with inflammatory bowel disease.”
The allowed patent claims cover the proprietary composition of PALI-2108. In preclinical studies, PALI-2108 demonstrated promising outcomes. In a DSS-induced UC mouse model, researchers observed a significant reduction in disease activity index (DAI) score over time compared to the control group. Notably, body weight loss was attenuated in specific dosage groups, showcasing the potential for targeted efficacy. PALI-2108’s unique design, incorporating a galactose-derived sugar moiety, allows for minimal absorption until cleaved by the colonic bacterium enzyme β-glucuronidase. This feature ensures localized bioactivation, leading to colon-specific distribution with limited systemic exposure, as confirmed by a tissue distribution study.
Palisade continues to advance PALI-2108 for the treatment of moderate-to-severe UC toward a Phase 1 clinical study, expected to be initiated before the end of 2024.
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; 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 Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission (“SEC”) on March 26, 2024 and May 13, 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
Source: Palisade Bio
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