FDA Clears PALISADE BIO IND for PALI-2108 in Crohn's Disease

Palisade Bio can start the Phase 2 ASCENTRA-CD trial of its oral PDE4 prodrug, with first dosing targeted for Q1 2027 and a primary readout in Q1 2028.

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Palisade Bio is developing an oral prodrug aimed at inflammatory bowel disease.

Palisade Bio (PALI) said the U.S. Food and Drug Administration has cleared its Investigational New Drug application for PALI-2108 in moderate to severe Crohn's disease, allowing the clinical-stage company to begin a Phase 2 trial called ASCENTRA-CD. The study is expected to enroll roughly 60 adult patients, with first patient dosing targeted for the first quarter of 2027 and the primary efficacy readout targeted for the first quarter of 2028.