Palisade Bio Completes Microbiome Study on PALI-2108 Bioactivation

Palisade Bio, Inc., a biopharmaceutical company listed on Nasdaq as PALI, recently announced significant findings from a study on the microbiome and enzymes in various species. The study aimed to understand the presence of beta-glucuronidase in the microbiomes of mice, dogs, and humans, including both healthy individuals and those suffering from Crohn’s disease (CD) and ulcerative colitis (UC). The company is making strides towards initiating a Phase 1 human clinical trial for their drug candidate PALI-2108, targeting ulcerative colitis, by the end of this year.

The research conducted by CosmosID utilized advanced methods to directly identify beta-glucuronidase using multiple databases. The results indicated that levels of this enzyme are consistent across different species and between healthy individuals and those with diseases. This consistency is crucial as it suggests that the prodrug can effectively break down in the gastrointestinal (GI) tract areas targeted for drug delivery. These findings also support earlier observations of adequate bioactivation of PALI-2108 in the stool samples of both normal healthy volunteers (NHV) and UC patients.

Public datasets for dogs, mice, and humans were sourced from the NCBI Sequence Read Archive and filtered for Illumina paired-end whole genome sequencing (WGS) data. The data samples were then standardized to 6 million reads each to ensure precise functional pathway and gene identification while maximizing sample comparison. These samples were analyzed using CosmosID-HUB for functional gene, enzyme, and pathway identification through databases like MetaCyc, Gene Ontology, and Enzyme Commission.

Although the study revealed significant overall functional differences between species, the specific functions related to beta-glucuronidase were not significantly different. The presence of beta-glucuronidase was consistent across species and between healthy and diseased human cohorts. The differences observed in the superpathway of beta D-glucuronoside degradation did not directly point to beta-glucuronidase but indicated the enzyme's likely presence.

Palisade Bio is progressing with the development of PALI-2108 for moderate-to-severe UC and plans to begin a Phase 1 clinical trial by the end of 2024. Additionally, the company is working on PALI-1908, a microbiota-activated PDE4 inhibitor prodrug designed for treating fibrostenotic Crohn’s Disease. This development leverages the advancements and findings associated with PALI-2108.

Palisade Bio's focus lies in creating novel therapeutics for autoimmune, inflammatory, and fibrotic diseases. By employing a targeted therapeutic approach, the company aims to transform the treatment landscape for these conditions.

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