Palisade Bio Announces First Patient Dosed in Global Phase 2b ASCENTRA-UC Study Evaluating Once-Daily Oral PALI-2108 for the Treatment of Ulcerative Colitis
Key Highlights
- ➤Palisade Bio (PALI) doses first patient in global Phase 2b ASCENTRA-UC trial
- ➤ASCENTRA-UC plans approximately 204 patients across two once-daily dose levels
- ➤29 of 30 planned U.S. sites activated; global expansion targets approximately 115 sites
- ➤12-week induction topline results expected in Q4 2027
Expert Statements
JD Finley, Chief Executive Officer of Palisade Bio
“Dosing the first patient in ASCENTRA-UC represents an important milestone for Palisade and for people living with ulcerative colitis, many of whom still lack durable, well-tolerated oral treatment options.”
JD Finley, Chief Executive Officer of Palisade Bio
“We believe PDE4 inhibition remains a compelling anti-inflammatory and anti-fibrotic mechanism.”
JD Finley, Chief Executive Officer of Palisade Bio
“PALI-2108’s prodrug design is intended to address historical tolerability limitations associated with this class.”
JD Finley, Chief Executive Officer of Palisade Bio
“Our goal is to develop a once-daily oral therapy that can deliver meaningful disease control on its own, with longer-term potential in combination with therapies targeting complementary pathways.”
JD Finley, Chief Executive Officer of Palisade Bio
“With U.S. enrollment underway and global expansion progressing, we look forward to reporting topline induction results in the fourth quarter of 2027.”
Mitch Jones, M.D., Ph.D., President and Chief Medical Officer of Palisade Bio
“ASCENTRA-UC is designed to rigorously evaluate the efficacy and safety of PALI-2108 across two once-daily oral dose levels, with clinical remission at Week 12 as the primary endpoint.”
Mitch Jones, M.D., Ph.D., President and Chief Medical Officer of Palisade Bio
“The study will also assess clinical response, endoscopic improvement and histologic-endoscopic mucosal improvement, along with the durability of treatment response.”
Mitch Jones, M.D., Ph.D., President and Chief Medical Officer of Palisade Bio
“Our Phase 1 findings showed early signals of clinical activity, sustained exposure of the active metabolite, and pharmacodynamic evidence of PDE4 pathway modulation.”
Mitch Jones, M.D., Ph.D., President and Chief Medical Officer of Palisade Bio
“Clinical site activation is, as of now, ahead of schedule, with substantially all U.S. sites now activated.”
Mitch Jones, M.D., Ph.D., President and Chief Medical Officer of Palisade Bio
“We look forward to determining whether these findings translate into meaningful clinical benefit in a larger, controlled patient population.”
PALI-2108 is an investigational, gut-activated, once-daily oral PDE4 inhibitor prodrug designed for sustained exposure and anti-inflammatory activity with the potential to improve tolerability
Global expansion progressing toward ~115 total sites, with CTA clearance in Canada and submissions under review in Europe and other international countries
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