Palisade Bio Completes First GMP Manufacturing of PALI-2108 Drug Substance and Product Batches

Palisade Bio, Inc., a biopharmaceutical company listed on Nasdaq as PALI, has announced significant progress in the development of its novel drug candidate PALI-2108, intended for the treatment of ulcerative colitis (UC). On July 11, 2024, the company disclosed the successful completion of the first Good Manufacturing Practice (GMP) batch of PALI-2108. This drug is an orally administered, colon-specific phosphodiesterase-4 (PDE4) inhibitor prodrug, aiming to provide relief to patients suffering from UC.

The production of the GMP batch was carried out in collaboration with Eurofins, a contract development and manufacturing organization. This partnership ensured the process development and scale-up of PALI-2108 adhered to stringent regulatory standards. The newly manufactured drug substance has already been used in murine and non-murine GLP toxicology studies and is set to be employed in the upcoming Phase 1 clinical trials.

Palisade Bio has also successfully completed the manufacturing and performance testing of engineering batches of the drug product. These include enteric-coated tablets designed to safeguard PALI-2108 from the conditions in the upper gastrointestinal tract, ensuring its release in the distal small intestine. The performance tests indicated that these tablets consistently demonstrated reliable drug release profiles, confirming the robustness of the formulation and the effectiveness of the enteric coating in delivering the active ingredient to the target site within the gastrointestinal tract.

J.D. Finley, Chief Executive Officer of Palisade Bio, expressed satisfaction with this milestone. He emphasized that the successful completion of the first GMP batch is a crucial step forward in the company's development program. The focus now shifts to the initiation of the Phase 1 clinical trial, which is expected to begin before the end of the year. Finley believes that the data generated from this trial will significantly support the clinical development of PALI-2108.

Palisade Bio is advancing PALI-2108 for treating moderate-to-severe UC and is preparing for its Phase 1 clinical study. In a DSS-induced UC mouse model, the treatment showed a notable reduction in the disease activity index (DAI) score over time compared to the control group. Additionally, body weight loss was mitigated in specific dosage groups, indicating the drug's potential for targeted efficacy.

Palisade Bio is dedicated to developing and advancing novel therapeutics designed for patients with autoimmune, inflammatory, and fibrotic diseases. The company aims to transform the treatment landscape through a targeted approach using its innovative therapies.

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