Palisade Bio Presents Development Overview of PALI-2108 at the IBD Innovate: Product Development for Crohn’s & Colitis™
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Insights
The announcement from Palisade Bio, Inc. regarding the advancement of PALI-2108 towards a Phase 1 clinical study is a significant step in the drug development process. The progression into clinical trials is a critical milestone for any biopharmaceutical company, as it marks the transition from preclinical research to testing in humans. This stage is particularly important for investors as it provides a tangible measure of a company's pipeline progression and can influence the company's stock valuation.
In the context of ulcerative colitis (UC), a chronic inflammatory bowel disease, the need for new treatment options remains high. Current treatments can have limitations in terms of efficacy and side effects. PALI-2108's unique mechanism as a colon-specific phosphodiesterase-4 (PDE4) inhibitor prodrug could provide a differentiated approach to UC management, potentially improving patient outcomes and adherence to therapy. The financial support from the US Crohn’s and Colitis Foundation underscores the potential and the interest in this therapeutic avenue.
From an industry perspective, the successful development of PALI-2108 could disrupt the UC market. However, the path to commercialization is long and fraught with risk. The outcome of the Phase 1 study will be closely monitored by investors as it will provide initial safety data and potentially some efficacy signals. This data will be essential for Palisade Bio's ability to attract further investment or partnership opportunities.
Palisade Bio's focus on PALI-2108 for the treatment of moderate-to-severe ulcerative colitis represents a strategic decision to address a chronic condition that affects millions worldwide. The drug's mechanism of action, as a locally acting colon-specific PDE4 inhibitor, targets inflammation at the site of disease, which may reduce systemic side effects often associated with current UC therapies. This specificity could represent a significant improvement in the therapeutic landscape of UC.
It is also worth noting that the support from a reputable organization such as the US Crohn’s and Colitis Foundation lends credibility to the research and development efforts. The funding agreement not only provides financial resources but also aligns the company with a network of experts and patients, which can be beneficial for future clinical trial recruitment and advocacy.
As PALI-2108 moves into Phase 1 trials, the data generated will be important in determining the drug's safety profile and optimal dosing. The outcome of this phase will also influence subsequent trial designs and ultimately the drug's path to market. For stakeholders, the results from these early trials will be a key indicator of the drug's potential and can significantly impact Palisade Bio's valuation.
The announcement of Palisade Bio's PALI-2108 entering Phase 1 clinical trials has implications for the competitive landscape of ulcerative colitis treatments. The current market is dominated by a few key players and the introduction of a new drug could potentially shift market dynamics. The differentiation strategy outlined by Palisade Bio suggests that they are positioning PALI-2108 to fulfill unmet needs within the UC treatment space, which could lead to a strong market entry if the drug's clinical outcomes are favorable.
Moreover, the oral presentation at IBD Innovate highlights the company's commitment to transparency and scientific communication. By providing access to the presentation on their website, Palisade Bio is fostering engagement with the scientific community and potential investors. This level of engagement is important for building confidence in the drug's development process and can influence investor sentiment.
Long-term, the success of PALI-2108 will depend on its efficacy, safety and cost-effectiveness compared to existing treatments. If the drug can demonstrate a favorable profile in these areas, it could capture a significant share of the UC treatment market. However, it is essential to remain cautious as the drug is still in early stages of development and many candidates fail to make it past clinical trials.
– PALI-2108 in development for the treatment of moderate-to-severe ulcerative colitis (UC) advancing towards Phase 1 clinical study before year end
Carlsbad, CA, April 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 presented at IBD Innovate: Product Development for Crohn’s & Colitis™ held April 9-10, 2024 in Cambridge, MA.
As part of the conference, Christophe Mellon, Chief Executive Officer of Giiant Pharma, Inc., the Company’s research partner, and Dr. Mitch Jones, Chief Medical Officer of Palisade Bio gave an oral presentation titled, “Advancing PALI-2108: Discovery to Strategy Positioning,” which discussed the development of PALI-2108, its differentiation and positioning in the competitive landscape as well as a clinical pathway towards late-stage development. The presentation is accessible on the Publications page under the Science section of Palisade Bio’s website, www.palisadebio.com.
“We were pleased to participate with Giiant at the premier IBD conference and provide further information on PALI-2108. We continue to generate a growing body of data from PALI-2108 for the treatment of UC and remain on track to launch our Phase 1 clinical study later this year," commented Dr. Jones.
As previously announced, the development of PALI-2108 is supported by a
PALI-2108 is an orally administered, locally acting colon-specific phosphodiesterase-4 (PDE4) inhibitor prodrug in development for patients affected by UC.
About IBD Innovate
The Crohn's & Colitis Foundation seeks to accelerate the discovery and development of novel products with the potential to address the unmet needs of patients with IBD. In pursuit of this objective, the foundation launched IBD Ventures to directly fund product discovery and development.
IBD Innovate is the premier IBD product development conference for therapeutics, diagnostics, devices, and digital health.
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, filed with the Securities and Exchange Commission (“SEC”) on March 26, 2024. 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
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