Palisade Bio (PALI) said the US Food and Drug Administration cleared its investigational new drug application for PALI-2108, allowing the company to begin a phase 2 study in adults with moderate-to-severe Crohn's disease.
The trial is expected to enroll about 60 adults and includes a 12-week induction phase followed by a 36-week maintenance phase, the company said Tuesday in a statement.
Palisade Bio expects to dose the first patient in Q1 2027 and report primary efficacy data in Q1 2028.
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