Palisade Bio 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 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.
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