Palisade Bio Announces Successful Completion of First GMP Manufacturing of PALI-2108 Drug Substance and Engineering Batches of Drug Product
Palisade Bio announced the successful completion of the first GMP manufacturing batch of its drug substance PALI-2108, targeted for treating moderate-to-severe ulcerative colitis (UC).
The company partnered with Eurofins for process development and scale-up. The drug substance has been utilized in completed murine and non-murine GLP toxicology studies and will be used in an upcoming Phase 1 clinical study set to start before the end of the year.
Palisade Bio also completed manufacturing and testing of enteric-coated tablets of PALI-2108, ensuring reliable drug release profiles. In a DSS-induced UC mouse model, significant reductions in disease activity index and body weight loss were observed, indicating promising efficacy.
CEO J.D. Finley emphasized the importance of this milestone in advancing effective therapies for UC patients and expressed optimism about the upcoming clinical trial data.
- Completion of first GMP manufacturing batch of PALI-2108 drug substance.
- Partnership with Eurofins for process development and scale-up.
- Successful completion of murine and non-murine GLP toxicology studies using PALI-2108.
- Manufacturing and performance testing of enteric-coated tablets demonstrated reliable drug release profiles.
- Reduction in disease activity index and body weight loss in DSS-induced UC mouse model.
- Phase 1 clinical study set to commence before the end of the year.
- None.
Insights
The completion of the first GMP batch for the drug substance PALI-2108 is a critical development for Palisade Bio. Good Manufacturing Practice (GMP) ensures that products are consistently produced and controlled according to quality standards. This step is pivotal for the credibility and safety profile of PALI-2108 as it moves towards human trials.
From a medical standpoint, the consistent and reliable drug release profiles of the engineering batches are significant. For a drug intended to treat ulcerative colitis (UC), the ability to deliver the active ingredient precisely to the lower digestive tract is paramount. The successful formulation of enteric-coated tablets addresses this need, potentially improving patient outcomes by ensuring that the drug acts where it is most needed.
Additionally, the promising results from the murine and non-murine studies, including reduced disease activity index (DAI) scores and attenuation of body weight loss, offer early indications of the drug's efficacy. This is particularly encouraging as it sets a solid foundation for the upcoming Phase 1 human clinical trials.
In summary, these developments are highly positive for Palisade Bio. They substantiate the company's technological capabilities and bode well for the next phases of clinical development.
The announcement marks a significant milestone for Palisade Bio from a financial perspective. Successful GMP manufacturing and completion of pivotal nonclinical studies are critical steps that de-risk the investment for stakeholders. These achievements demonstrate that Palisade Bio is on track with its development timelines, which is reassuring for investors.
This progress also positions the company well for securing additional funding, whether through equity offerings or strategic partnerships. The partnership with Eurofins for process development and scale-up further enhances confidence in Palisade's operational capabilities.
The market typically views milestones such as GMP manufacturing and approaching Phase 1 clinical trials positively, as they indicate forward momentum and potential for future revenue streams. Investors should monitor the upcoming Phase 1 trial closely, as it will provide key data that can significantly impact stock valuation and investor sentiment.
Overall, this announcement contributes positively to Palisade Bio's financial outlook, increasing the likelihood of continued support from investors and potential partners.
Company has now completed murine and non-murine pivotal nonclinical studies using GMP PALI-2108 drug substance
Company has successfully formulated enteric-coated tablets of PALI-2108 and has demonstrated consistent and reliable drug release profiles
Company on track to commence Phase 1 human clinical study of PALI-2108 for the treatment of moderate-to-severe ulcerative colitis (UC) before year end
Carlsbad, CA, July 11, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”), a biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, today announced the successful completion of the first Good Manufacturing Practice (GMP) batch of its drug substance PALI-2108, an orally administered, locally acting colon-specific phosphodiesterase-4 (PDE4) inhibitor prodrug in development for patients affected by UC.
The GMP manufacturing was conducted in partnership with Eurofins, a contract development and manufacturing organization. This partnership included process development and scale-up of PALI-2108 to ensure adherence to regulatory standards. The drug substance produced has been successfully implemented in the Company’s completed murine and non-murine GLP toxicology studies and is slated for use in its upcoming Phase 1 clinical study.
In addition to the successful production of the drug substance, Palisade has completed manufacturing and performance testing of engineering batches of the drug product. These batches consist of enteric-coated tablets designed to protect PALI-2108 from upper gut conditions and to be released distally within the small intestine. The drug product batches have consistently demonstrated reliable drug release profiles, highlighting the formulation's robustness and the enteric coating's effectiveness in delivering the active ingredient to the intended site within the gastrointestinal tract.
"We are pleased to achieve this critical milestone in our journey towards developing effective therapies for patients in need," said J.D. Finley, Chief Executive Officer of Palisade. "The successful completion of our first GMP batch for PALI-2108 marks a significant step forward for our development program. We remain focused on the initiation of our Phase 1 clinical trial, expected before the end of this year, and look forward to generating meaningful data that will further support the clinical development of PALI-2108."
Palisade continues to advance PALI-2108 for the treatment of moderate-to-severe UC toward a Phase 1 clinical study. 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.
For more information about PALI-2108 and the Company’s clinical development programs, visit www.palisadebio.com.
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
FAQ
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