Health Canada Clears Palisade Bio's Phase 2 ASCENTRA-UC Trial of Oral PDE4 Prodrug PALI-2108
核心洞察
Health Canada has cleared Palisade Bio's Clinical Trial Application for ASCENTRA-UC, a global Phase 2 study of PALI-2108 in moderately to severely active ulcerative colitis (搜索).
The clearance expands the trial's geographic reach alongside prior US regulatory clearance and supports planned site activation and enrollment in Canada.
The randomized, double-blind, placebo-controlled study will enroll about 204 patients and test once-daily 15 mg and 30 mg doses against placebo.
Palisade Bio has received Clinical Trial Application clearance from Health Canada for ASCENTRA-UC, the company's global Phase 2 study of PALI-2108 in patients with moderately to severely active ulcerative colitis (搜索). The clearance, announced Sept. 23, 2026, allows Palisade to advance clinical trial activities in Canada, expanding the study's geographic reach and supporting planned enrollment.
The Canadian authorization follows prior regulatory clearance in the United States and advances the company's global site activation and enrollment strategy. Palisade said it remains on track to begin patient dosing in the second half of 2026, with primary efficacy results from the study's 12-week induction period expected in the second half of 2027.
"Health Canada clearance represents another important execution milestone as we advance ASCENTRA-UC globally," said JD Finley, Chief Executive Officer of Palisade Bio. "Our focus is on efficiently activating sites, expanding patient access to the study and delivering the clinical data needed to define PALI-2108's potential in ulcerative colitis (搜索)."
Trial Design and Endpoints
ASCENTRA-UC is a global, multicenter, randomized, double-blind, placebo-controlled, dose-ranging Phase 2 trial designed to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of PALI-2108. The study is expected to enroll approximately 204 patients with moderately to severely active ulcerative colitis (搜索) and will evaluate once-daily 15 mg and 30 mg doses of PALI-2108 compared with placebo.
The primary endpoint is clinical remission at Week 12, as measured by the modified Mayo Score. Key secondary endpoints include clinical response, endoscopic improvement and histologic-endoscopic mucosal improvement. The trial also includes a 36-week maintenance phase extension designed to evaluate durability of response and longer-term safety through Week 48.
"PALI-2108 is designed to combine the convenience of once-daily oral dosing with targeted activation in the terminal ileum and colon," said Mitch Jones, M.D., Ph.D., President and Chief Medical Officer of Palisade Bio. "ASCENTRA-UC builds on the clinical and pharmacologic findings observed to date and will rigorously evaluate whether this approach can translate into clinical remission and mucosal improvement. Expanding the study into Canada supports enrollment and brings us closer to answering these important clinical questions."
Prodrug Designed for Lower-Intestinal Activation
PALI-2108 is a once-daily oral PDE4 (搜索) inhibitor prodrug designed for targeted activation in the terminal ileum and colon. Across Phase 1 studies in healthy volunteers and patients with ulcerative colitis (搜索) and fibrostenotic Crohn's disease (搜索), the candidate demonstrated favorable safety and tolerability, differentiated pharmacokinetics and sustained PDE4 inhibition above IC90, supporting advancement into Phase 2 development.
Ulcerative colitis (搜索) is a form of inflammatory bowel disease that causes inflammation in the lining of the colon and rectum. Palisade is advancing PALI-2108 as a treatment for patients living with inflammatory bowel disease, including ulcerative colitis and Crohn's disease (搜索). According to the company, many patients with these conditions do not achieve durable remission despite the availability of multiple biologic and small-molecule therapies, lose response over time, or discontinue treatment because of safety or tolerability limitations. Palisade believes PALI-2108 has the potential to address these limitations through once-daily oral dosing, targeted lower-intestinal bioactivation and broad PDE4 (搜索)-mediated anti-inflammatory activity.