Biopharmaceutical Company Announces Completion of Oral Drug Substance For UC
Palisade Bio Announces Successful Completion of First GMP Manufacturing of PALI-2108 Drug Substance and Engineering Batches of Drug Product.
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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, has recently made a advancement in its drug development program. The Company 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 currently under development for patients affected by ulcerative colitis (UC).
Collaboration with Eurofins
The GMP manufacturing process was conducted in collaboration with Eurofins, a contract development and manufacturing organization. This partnership was instrumental in the process development and scale-up of PALI-2108 to ensure strict adherence to regulatory standards. The manufactured drug substance has already been implemented in the Company’s completed murine and non-murine GLP toxicology studies and is designated for use in its forthcoming Phase 1 clinical study.
Eurofins' involvement was crucial in not only meeting but exceeding the manufacturing standards required for new drug substances. Their extensive expertise in the field contributed to the successful completion of the GMP batch, marking a vital milestone in the development of PALI-2108. In addition to producing the drug substance, Palisade Bio has completed the manufacturing and performance testing of engineering batches of the drug product. These batches consist of enteric-coated tablets designed to protect PALI-2108 from the harsh conditions of the upper gastrointestinal tract, ensuring its release in the distal regions of the small intestine. This targeted release mechanism is crucial for the drug’s efficacy, as it allows the active ingredient to act precisely at the site of inflammation within the colon.
The engineering batches underwent rigorous performance testing to validate their effectiveness. The tests confirmed that the enteric coating successfully protected the drug from premature release, and the drug release profiles demonstrated consistency and reliability. This robustness in formulation reveals the potential of PALI-2108 to effectively treat UC by delivering the active ingredient specifically where it is needed most.
Statements from Leadership
J.D. Finley, Chief Executive Officer of Palisade Bio, expressed his satisfaction with this critical achievement: “We are pleased to achieve this critical milestone in our journey towards developing effective therapies for patients in need. 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.”
Finley's statement highlights the importance of this milestone in the broader context of the Company’s ongoing efforts to develop innovative treatments for debilitating diseases such as UC. The upcoming Phase 1 clinical trial represents the next pivotal step in evaluating the safety and efficacy of PALI-2108 in human subjects. Palisade Bio is steadfast in its commitment to advancing PALI-2108 for the treatment of moderate-to-severe UC. The drug has shown promising results in preclinical studies, including a DSS-induced UC mouse model where researchers observed a reduction in the disease activity index (DAI) score over time compared to the control group. Additionally, body weight loss, a common symptom in UC models, was attenuated in specific dosage groups, indicating the potential for targeted therapeutic efficacy.
These preclinical findings suggest that PALI-2108 could offer a new therapeutic option for patients suffering from UC, a chronic and often debilitating inflammatory bowel disease. By targeting the PDE4 enzyme specifically within the colon, PALI-2108 aims to reduce inflammation and improve patient outcomes without the systemic side effects associated with traditional treatments. As Palisade Bio prepares for the initiation of its Phase 1 clinical trial, the Company continues to focus on its mission to develop and deliver novel therapies for patients with unmet medical needs. The successful GMP manufacturing of PALI-2108 and the completion of engineering batches represent progress in this journey.
The Phase 1 trial will be a critical stage in the clinical development process, providing initial insights into the drug’s safety profile and pharmacokinetics in human subjects. Positive results from this trial could pave the way for subsequent phases of clinical testing, bringing PALI-2108 closer to potential regulatory approval and commercialization.
Palisade Bio is a biopharmaceutical company dedicated to developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases. The Company's approach involves leveraging targeted therapies to transform the treatment landscape for these challenging conditions. Palisade Bio's pipeline includes several promising candidates aimed at addressing unmet medical needs.
Disclaimer: This article is intended for informational purposes only and does not constitute financial advice. Readers should perform their own research and consult with a professional financial advisor before making any investment decisions. The information provided herein is based on publicly available sources and is subject to change.
Real-time information is available daily at https://stockregion.net