Palisade Bio Announces European Patent Office Issued a Decision to Grant Notice for Patent for Lead Product Candidate, PALI-2108

Rhea-AI Summary

Palisade Bio (Nasdaq: PALI) announced that the European Patent Office has issued a decision to grant notice for patent number 4,157,853, titled 'Gut Microbiota Bioactivated PDE4 Inhibitor Precursors.' This patent, expected to be issued on July 31, 2024, includes composition of matter claims for PALI-2108 and PALI-1908, providing coverage beyond 2042. PALI-2108 is being developed for moderate-to-severe Ulcerative Colitis, while PALI-1908 targets fibro stenotic Crohn's Disease.

The patent claims cover PALI-2108's proprietary composition, designed as an orally administered, colon-specific PDE4 inhibitor prodrug. Its unique galactose-derived sugar moiety allows for minimal absorption until cleaved by colonic bacteria, ensuring localized bioactivation. Palisade Bio plans to initiate a Phase 1 clinical study for PALI-2108 before the end of 2024.

Positive

• European Patent Office issued a decision to grant notice for patent covering PALI-2108 and PALI-1908
• Patent provides composition of matter coverage beyond 2042
• PALI-2108 demonstrates encouraging data for inflammatory bowel disease treatment
• Phase 1 clinical study for PALI-2108 expected to be initiated before the end of 2024
• Expanding global intellectual property portfolio strengthens company's market position

Negative

• None.

Medical Research Analyst

Palisade Bio's announcement of a new patent for its lead product candidates, PALI-2108 and PALI-1908, is worth examining, especially from a medical research perspective. The patent extends coverage for these therapies, promising longevity in their commercial viability.

PALI-2108 targets Ulcerative Colitis (UC) with a precise mechanism reliant on colonic bacterium enzyme β-glucuronidase, potentially ensuring minimal systemic absorption and localized efficacy. This specificity can translate into fewer side effects compared to traditional systemic treatments, making it more appealing for patients and healthcare providers.

For PALI-1908, aimed at fibro stenotic Crohn’s Disease (CD), the novelty lies in its microbiota-activated PDE4 inhibition, leveraging insights from PALI-2108. Such targeted therapies are at the forefront of medical research, often leading to better patient outcomes through tailored treatments. However, it is imperative to consider the clinical trial phases still pending. Key data from these phases will be important in determining the efficacy and safety of these candidates.

This development is a strong signal to investors about the innovative capabilities and future potential of Palisade Bio's pipeline, yet keeping an eye on clinical progress and approval timelines is vital.

Market Research Analyst

The issuance of the European patent for Palisade Bio's PALI-2108 and PALI-1908 holds significant market implications. Securing patent protection in Europe, paired with existing patents in Canada, underscores the company’s robust intellectual property strategy, effectively extending market exclusivity beyond 2042. This long-term protection can provide a competitive edge, potentially leading to favorable revenue streams without immediate threats from generic competition.

From a market perspective, focusing on autoimmune and inflammatory diseases like Ulcerative Colitis and Crohn’s Disease positions Palisade Bio well within a rapidly expanding therapeutic area. These conditions have considerable market demand due to their chronic nature and the need for improved treatment options.

Investors should particularly note the strategic move to initiate clinical studies by the end of 2024. Successful trials could not only validate the efficacy of these products but also significantly boost the company's market valuation and investor confidence. However, it's wise to remain cautious about the inherent uncertainties and potential delays associated with clinical developments.

Patent includes Composition of Matter claims for both PALI-2108 and PALI-1908 programs

Patent includes broad claims for “Gut Microbiota Bioactivated PDE4 Inhibitor Precursors” with similar structure to PALI-2108 and PALI-1908

This patent family provides Composition of Matter coverage beyond 2042

PALI-2108 is in development to treat patients with active moderate-to-severely active Ulcerative Colitis (UC)

PALI-1908 is in development to treat patients with active fibro stenotic Crohn’s Disease (CD)

Carlsbad, CA, July 19, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (the “Company”), a biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, today announced that European Patent Office (EPO) has issued a decision to grant notice for patent number 4,157,853 titled, “Gut Microbiota Bioactivated PDE4 Inhibitor Precursors.” Based on the intention to grant notice, the Company expects the EPO to issue a patent July 31, 2024. In addition to this European patent and recently allowed Canadian patent, the Company continues to strengthen its global intellectual property portfolio surrounding PALI-2108 with submitted and planned submissions of additional patent applications.

J.D. Finley, Chief Executive Officer of Palisade commented, “We are pleased to further expand our global patent estate for our PALI-2108 and PALI-1908 programs with this European patent. PALI-2108 continues to demonstrate encouraging data and bolster our confidence in its potential as a next-generation therapeutic option for patients with inflammatory bowel disease. As we continue to execute on the development pathway forward for PALI-2108 and PALI-1908, we remain committed to strengthening our global intellectual property portfolio.”

The patent claims include coverage for the proprietary 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). PALI-2108’s unique design, incorporating a galactose-derived sugar moiety, potentially allows for minimal absorption until cleaved by the colonic bacterium enzyme β-glucuronidase. This feature is intended to ensure localized bioactivation, leading to colon-specific distribution with limited systemic exposure, as shown 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. The Company’s PALI-1908 candidate is a microbiota-activated PDE4 inhibitor prodrug that leverages the advancements made with PALI-2108 and is being developed for the treatment of fibro stenotic Crohn’s Disease.

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

FAQ

What is the significance of the European patent for Palisade Bio's PALI-2108 and PALI-1908?

The European patent provides composition of matter coverage for PALI-2108 and PALI-1908 beyond 2042, strengthening Palisade Bio's intellectual property portfolio and market position for these drug candidates targeting Ulcerative Colitis and Crohn's Disease, respectively.

When is Palisade Bio (PALI) expected to initiate the Phase 1 clinical study for PALI-2108?

Palisade Bio plans to initiate the Phase 1 clinical study for PALI-2108, targeting moderate-to-severe Ulcerative Colitis, before the end of 2024.

What is unique about PALI-2108's design according to the patent?

PALI-2108 incorporates a galactose-derived sugar moiety, allowing for minimal absorption until cleaved by colonic bacteria. This design ensures localized bioactivation and colon-specific distribution with systemic exposure.

How does PALI-1908 differ from PALI-2108 in terms of its target condition?

While PALI-2108 is being developed for moderate-to-severe Ulcerative Colitis, PALI-1908 is targeted at treating fibro stenotic Crohn's Disease. Both are microbiota-activated PDE4 inhibitor prodrugs.