Biopharmaceutical Company Announces Notice of Allowance For Patent Over UC Treatment
Palisade Bio Announces Notice of Allowance for Canadian Patent Covering Lead Product Candidate, PALI-2108.
Disclaimer: The following article is based on a press release from Palisade Bio and is intended for informational purposes only. It should not be taken as financial advice or an endorsement of any company or product.
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Palisade Bio, Inc. (Nasdaq: PALI), a biopharmaceutical company dedicated to developing novel therapeutics for autoimmune, inflammatory, and fibrotic diseases, has recently announced a milestone in its intellectual property portfolio. 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 pertains to the composition of PALI-2108, the Company's lead product candidate, which is an orally administered, locally acting colon-specific Phosphodiesterase-4 (PDE4) inhibitor prodrug. PALI-2108 is being developed for the treatment of Ulcerative Colitis (UC), a chronic inflammatory bowel disease.
The Patent Allowance
The issuance of the Notice of Allowance by the CIPO marks a pivotal moment for Palisade Bio. J.D. Finley, Chief Executive Officer of Palisade Bio, expressed the company's commitment to fortifying its intellectual property estate around PALI-2108. He emphasized that this is the first patent notice of allowance for the composition of matter for PALI-2108, enabling the establishment and expansion of a robust patent family across multiple geographies.
The allowed patent claims cover the proprietary composition of PALI-2108. This composition is integral to the drug's functionality and efficacy. PALI-2108 is designed to be a colon-specific PDE4 inhibitor prodrug, meaning it is activated in the colon rather than in other parts of the gastrointestinal tract or systemically. This specificity reduces potential side effects and enhances the drug's effectiveness for treating UC. In preclinical studies, PALI-2108 demonstrated promising outcomes. One of the key studies involved 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. These results suggest that PALI-2108 could offer significant therapeutic benefits for patients suffering from UC.
Mechanism of Action: PALI-2108โs unique design incorporates a galactose-derived sugar moiety, which allows for minimal absorption until cleaved by the colonic bacterium enzyme ฮฒ-glucuronidase. This feature ensures localized bioactivation, leading to colon-specific distribution with limited systemic exposure. A tissue distribution study confirmed that the drug remains largely localized in the colon, thereby minimizing systemic side effects and enhancing its therapeutic profile. This mechanism of action is particularly advantageous for treating conditions like UC, where localized treatment can significantly reduce inflammation without the broader impacts of systemic drugs.
Moving Towards Clinical Trials
Palisade Bio is progressing towards initiating a Phase 1 clinical study for PALI-2108. This study, expected to commence before the end of 2024, will be crucial in determining the safety, tolerability, and preliminary efficacy of PALI-2108 in human subjects. The transition from preclinical studies to human trials marks a step forward in the drug development process, potentially bringing a new therapeutic option closer to patients who need it. The successful advancement of PALI-2108 through clinical trials could make it the first approved PDE4 inhibitor specifically for UC. This would represent a major breakthrough in the treatment of inflammatory bowel diseases, providing a new, targeted therapeutic option for patients. The existing data and the upcoming clinical studies reveal the potential of PALI-2108 as a next-generation therapeutic option for those suffering from conditions such as UC.
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 can transform the treatment landscape and improve patient outcomes. Palisade Bio is committed to innovation and excellence in drug development, aiming to address unmet medical needs in these challenging disease areas.
The Notice of Allowance for the Canadian patent covering the composition of PALI-2108 represents a milestone for Palisade Bio. It strengthens the company's intellectual property portfolio and paves the way for further advancements in the development of PALI-2108. With promising preclinical data and plans to initiate Phase 1 clinical trials, Palisade Bio is poised to make substantial contributions to the treatment of ulcerative colitis and other inflammatory diseases. The company's dedication to innovation and targeted therapeutics underscores its mission to improve the lives of patients with autoimmune, inflammatory, and fibrotic diseases.
Disclaimer: The above article is based on a press release from Palisade Bio and is intended for informational purposes only. It should not be taken as financial advice or an endorsement of any company or product.
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