Palisade Bio, Inc. 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. 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.