Palisade Bio Cleared by Health Canada to Commence Phase 1 Clinical Study for Lead Program, PALI-2108 for the Treatment of Ulcerative Colitis (UC)
– Company has received a No Objection Letter from Health Canada in response to submission of its Phase 1 Clinical Trial Application (CTA)
– The study is a Phase 1 Single Ascending Dose (SAD) /Multiple Ascending Dose (MAD) and food effects (FE) and includes multiple dose treatment of UC patients; Global UC market is expected to grow to nearly $10 Billion by 2028
Excerpt from the Press Release:
Carlsbad, CA, Oct. 10, 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 that it has received a No Objection Letter from Health Canada for its Phase 1 human clinical study for PALI-2108 for the treatment of UC.
“We are thrilled to receive a No Objection Letter from Health Canada in response to our Clinical Trial Application. This achievement marks the most important milestone to date for our PALI-2108 development program. We continue to believe in the potential of PALI-2108 to be the first approved PDE4 inhibitor for UC and more importantly, provide a much-needed effective and safe solution for UC patients still experiencing significant medical need. Our team remains focused on continuing preparations for the initiation of our Phase 1 clinical trial which is on track to commence before year end,” commented J.D. Finley, Chief Executive Officer.
PALI-2108 is an orally administered PDE4 inhibitor prodrug which is locally bioactivated in the colon and is in development for patients affected by UC. The Phase 1 study will evaluate PALI-2108 in a single-center, double-blind, placebo-controlled study focused on safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers, alongside an open-label study involving a patient cohort with UC.
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