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Palisade Bio Announces Successful Completion of First GMP Manufacturing of PALI-2108 Drug Substance and Engineering Batches of Drug Product
Company has now completed murine and non-murine pivotal nonclinical studies using GMP PALI-2108 drug substance Company has successfully formulated
About this update from Palisade Bio, Inc.
[{"type":"text","content":"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 ...