India, June 29 -- Palisade Bio, Inc. (PALI), a clinical-stage biopharmaceutical company, marked a development milestone on Monday, as the U.S. Food and Drug Administration (FDA) cleared the company's Investigational New Drug (IND) application for its lead program, PALI-2108, in patients with moderately to severely active ulcerative colitis (UC).
The clearance enables initiation of the global Phase 2 ASCENTRA-UC clinical trial for PALI-2108.
PALI-2108 has demonstrated supportive Phase 1a and Phase 1b clinical data in ulcerative colitis and Fibrostenotic Crohn's disease according to the company.
ASCENTRA-UC Phase 2 Trial Design ASCENTRA-UC will be a multicenter, randomized, double-blind, placebo-controlled, dose-ranging Phase 2 clinical tr...