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Palisade Bio Selects Dose for Upcoming Phase 1 Clinical Study of PALI-2108 for Ulcerative Colitis
– Phase 1 human clinical study of PALI-2108 for the treatment of Ulcerative Colitis (UC) on track to commence before year end – Based on the modeling and
About this update from Palisade Bio, Inc.
[{"type":"text","content":"– Phase 1 human clinical study of PALI-2108 for the treatment of Ulcerative Colitis (UC) on track to commence before year end – Based on the modeling and simulations, Palisade has established dose levels and trial design for PALI-2108 Carlsbad, CA, Aug. 08, 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 provided a progress update on the advancement of development for its lead drug candidate, PALI-2108 towards initiation of Phase 1 clinical trials in healthy volunteers and patients with Ulcerative Colitis (UC). PALI-2108 is an orally administered, locally acting colon-specific PDE4 inhibitor prodrug in development for patients affected by UC. “To establish the Maximum Recommended Starting Dose (MRSD) for human trials, we utilized several complementary scaling approaches. These methods included integrating data from IV and oral (PO) administrations of PALI-2108 across various species. By modeling total PK data, we have gathered data that we believe accurately translates to exposure in humans and ensures a safe and scientifically grounded starting point for our upcoming planned clinical studies. We are pleased with the progress made and look forward to commencing our Phase 1 clinical trial before the end of the year,” commented Dr. Mitch Jones, CMO of Palisade Bio. The Company has completed an extensive range of studies to determine the starting dose for PALI-2108 in its planned Phase 1 study. The preclinical studies included pharmacodynamic (PD) studies in mice, pharmacokinetic (PK) studies across multiple species (mice, rats, dogs, and monkeys), and a series of in vitro experiments to profile PALI-2108’s drug metabolism and pharmacokinetics (DMPK) characteristics. Additionally, the Company has completed its pivotal Good Laboratory Practice (GLP) safety and toxicology studies which have provided relevant data for this determination. Key Findings from PK Modeling and Simulations Comprehensive simulations were conducted for both single and multiple dose administrations. Scenarios ranged over expected Phase 1 dosing levels and assessed both single and multiple daily doses. The simulations indicated that dosing regim...