Palisade Bio (NASDAQ: PALI) shares skyrocketed by almost 85% on Monday after a biopharmaceutical company announced positive preclinical data for lead program PALI-2108 at the 2024 Crohn’s & Colitis Congress.
Palisade Bio (PALI) has made public the positive preclinical data of its primary asset, PALI-2108. This announcement was made during the Crohn’s & Colitis Congress, which took place in Las Vegas, NV, from January 25-27, 2024.
The preclinical data was displayed on a poster titled; “Local Bioactivation and Efficacy of PALI-2108: A Promising PDE4 Inhibitor Prodrug for Ulcerative Colitis Treatment.”
PALI-2108, a prodrug under development by the Company, is an orally administered, colon-specific phosphodiesterase-4B (PDE4B) inhibitor. It is developed for patients with moderate to severe active ulcerative colitis (UC).
Key Findings from Preclinical Studies
The Crohn’s and Colitis Foundation has presented results from multiple preclinical studies of PALI-2108. The Company’s research aims to overcome the drawbacks of existing PDE4 inhibitors, including CNS toxicity and systemic distribution, which frequently result in therapy discontinuation.
In preclinical trials, PALI-2108 showed encouraging results. A significant decrease in the disease activity index (DAI) score was observed in a DSS-induced UC mouse model compared to the control group. Notably, the body weight loss was mitigated in certain dosage groups, indicating potential for targeted effectiveness.
The unique design of PALI-2108, which includes a galactose-derived sugar component, permits limited absorption until it is cleaved by the colonic bacterial enzyme β-glucuronidase. This feature guarantees localized bioactivation, resulting in colon-specific distribution with limited systemic exposure, as validated by a tissue distribution study. The colon/plasma AUC ratio surpassing 200 further underscores PALI-2108’s predilection for the colon.
Furthermore, the Company’s research indicates colon-specific bioactivation in oxazolone colitis-induced mice, insignificant plasma levels in duodenal and ileal tissue, and similar target engagement to other PDE4 inhibitors. A tolerated dose study in dogs showed no CNS toxicity or vomiting over effective doses, addressing a critical issue related to oral administration.
In summary, the Company’s preclinical studies revealed that PALI-2108 exhibited:
- Local bioactivation;
- Colon-specific distribution;
- Similar target engagement to other PDE4 inhibitors;
- Dose-dependent efficacy in a mouse UC model; and
- No systemic toxicity in dogs and a large therapeutic window due to local activation.
Palisade Bio (NASDAQ: PALI) Stock Performance
PALI stock soared 84.62% on Monday. The traders had exchanged hands with 135,301,530 (135.30 million) shares compared to the average daily trading volume of 292.22 thousand.
