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Curated data show expression of PDE4B above a specific measurable threshold observed in 70% of adult colitis patients and 90% of pediatric colitis patients
Company is advancing lead program PALI-2108, an orally administered, locally acting colon-specific PDE4 inhibitor prodrug in development for patients affected by Ulcerative Colitis (UC)
Phase 1 human clinical study of PALI-2108 for the treatment of UC on track to commence before year end
Carlsbad, CA, Sept. 05, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade,” “Palisade Bio,” or the “Company”), a biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, today announced the successful completion of refined patient selection strategies based on PDE4-related biomarkers and disease characteristics to optimize clinical outcomes for patients with UC as part of its collaboration with Strand Life Sciences (“Strand”).
As part of the ongoing collaboration with Strand, RNAseq datasets were analyzed using a standardized bioinformatics pipeline, which generates normalized TPM counts for each gene. The analysis found that PDE4B expression is significantly higher in most colitis patients, encompassing both adult and pediatric cohorts. This suggests that PDE4B could be a crucial factor in patient stratification. In adults, a PDE4B over-expression level was determined that the Company believes accurately identifies 70% of moderate to severe cases. In pediatric patients, a PDE4B over-expression level was determined that the Company believes accurately identifies 90% of those with moderate to severe colitis.
“These findings underscore the potential of PDE4B expression as a valuable tool in the precision medicine toolkit for colitis. By tailoring treatment strategies based on PDE4B levels, healthcare providers can offer more personalized and effective interventions for patients suffering from this challenging condition,” commented Dr. Mitch Jones, CMO of Palisade Bio. “PALI-2108 continues to demonstrate promising potential for the treatment of UC, and we look forward to commencing our Phase 1 clinical trial before the end of the year.”
In addition, in a DSS-induced UC mouse model demonstrated increased colon tissue PDE4B levels with induction of DSS colitis and significant reductions in colon tissue PDE4B expression in response to increasing doses of PALI-2108, closely correlated with increasing levels of colon tissue cAMP, and closely correlated to colon tissue inflammatory cytokines such as TNF-alpha. As well, researchers observed a significant reduction in disease activity index score over time compared to the control treated group. Further, body weight loss and changes in colon length were attenuated in increasing dosage groups, showcasing the potential for targeted efficacy.
For more information about PALI-2108 and the Company’s clinical development programs, visit www.palisadebio.com.
Palisade Bio is a biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases. The Company believes that by using a targeted approach with its novel therapeutics it will transform the treatment landscape. For more information, please go to www.palisadebio.com.
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