Palisade Bio Receives Notice of Allowance for Composition of Matter Patent Covering Lead Product Candidate PALI-2108 in China
Rhea-AI Summary
Palisade Bio (NASDAQ:PALI) has received a Notice of Allowance from the China National Intellectual Property Administration for a patent covering PALI-2108, their lead product candidate. The patent, titled "Gut Microbiota-Activated PDE4 Inhibitor Prodrug," will extend into 2045 and covers composition of matter claims.
PALI-2108 is a first-in-class PDE4 inhibitor targeting the terminal ileum and colon for treating fibrostenotic Crohn's disease (FSCD) and ulcerative colitis (UC). The drug is currently being evaluated in a Phase 1b/2a clinical trial. The Chinese Inflammatory Bowel Disease market represents a significant opportunity, with forecasts approaching $1B in total revenues by 2030.
Positive
- Patent protection in China extends until 2045, securing long-term market exclusivity
- Targeting Chinese IBD market with projected $1B revenue potential by 2030
- Multiple clinical milestones and data readouts expected in next 12-18 months
- First-in-class therapy status for PALI-2108 in FSCD and UC treatment
Negative
- Drug still in early clinical stages (Phase 1b/2a) with uncertain outcome
- Patent extensions subject to regulatory approval requirements
Insights
PALI secures patent protection in China for its novel IBD drug PALI-2108, extending IP rights through 2045 in a growing billion-dollar market.
Palisade Bio has secured a critical Notice of Allowance from China's intellectual property authority for its lead product candidate PALI-2108, a novel PDE4 inhibitor targeting inflammatory bowel diseases. This patent milestone extends protection until 2045 in one of the world's largest pharmaceutical markets, where IBD treatment revenues are projected to reach
The allowed patent covers composition of matter claims for PALI-2108, which is currently in Phase 1b/2a clinical trials for fibrostenotic Crohn's disease (FSCD) and moderate to severe ulcerative colitis (UC). This represents strong IP protection for PALI-2108's innovative mechanism as the first PDE4 inhibitor specifically designed to target the terminal ileum and colon.
China's pharmaceutical landscape presents significant growth opportunities for Palisade Bio. With a large population and increasing IBD diagnosis rates, securing IP protection in this territory enhances the company's commercial positioning and partnership potential. The extended protection timeline substantially increases the drug's potential lifetime value, creating a stronger foundation for future commercialization efforts.
The patent allowance comes at a strategic time as the company progresses through multiple clinical milestones. With data readouts expected in the next 12-18 months, this IP protection reduces competitor risk during this critical development phase. For a clinical-stage biotech company like Palisade, building a robust global patent estate is essential for maximizing asset value prior to potential partnerships or commercial launch.
PALI-2108 is the first and only PDE4 inhibitor designed to target terminal ileum and colon for fibrostenotic Crohn’s disease (FSCD) and ulcerative colitis (UC), to address significant unmet medical needs
Inflammatory Bowel Disease is a large and growing market opportunity in China, with forecasts approaching
Carlsbad, CA, July 31, 2025 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade,” “Palisade Bio,” or the “Company”), a clinical-stage biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, today announced that the China National Intellectual Property Administration has issued a Notice of Allowance for a patent covering PALI-2108, the Company’s novel, locally-activated, terminal ileum and colon-targeted phosphodiesterase-4 B/D (PDE4 B/D) inhibitor being developed for fibrostenotic Crohn’s disease (FSCD) and moderate to severe ulcerative colitis (UC).
Once issued, the allowed patent titled, “Gut Microbiota-Activated PDE4 Inhibitor Prodrug,” will cover claims on the composition of matter for PALI-2108 in China with a base patent term currently extending into 2045, subject to extension to account for time required to fulfill requirements for regulatory approval.
“Strengthening the global intellectual property portfolio around PALI-2108 remains a priority as we continue advancing this first-in-class therapy for FSCD and UC,” said J.D. Finley, Chief Executive Officer of Palisade Bio. “This Notice of Allowance in China bolsters our ability to protect long-term value in one of the world’s largest and fastest-growing pharmaceutical markets, further supporting both our clinical and strategic objectives. We remain highly confident in the potential of PALI-2108 and are diligently executing on multiple near-term clinical milestones and expected data readouts in the next 12-18 months, each of which, if successful, would represent a major value inflection point.”
The Company is currently evaluating PALI-2108 in a Phase 1b/2a clinical trial for the treatment of FSCD and UC. For more information about the Phase 1a/b clinical study, visit clinicaltrials.gov and reference identifier NCT06663605.
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, but are not limited to, statements regarding the safety and tolerability, PK and drug release characteristics of PALI-2108 based on the Company’s preclinical studies and preliminary data from the Company’s clinical studies and indications and anticipated benefits of PALI-2108. These forward-looking statements are based upon the Company’s current expectations. Forward-looking statements involve risks and uncertainties. Important factors that could cause actual results to differ materially from those reflected in the Company’s forward-looking statements include, among others, the timing of enrollment, commencement and completion of the Company’s clinical trials, the timing and success of preclinical studies and clinical trials conducted by the Company, the risk that prior results, such as signals of safety, activity, or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving the Company’s product candidates in clinical trials focused on the same or different indications; 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, 2024, filed with the SEC on March 24, 2025, as well as the Company’s Quarterly Report on Form 10-Q, for the three-month period ended March 31, 2025, filed with the SEC on May 12, 2025. 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
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