Cure8 news brief
New Phase II trials test whether a gut-activated oral PDE4 inhibitor can treat moderate-to-severe ulcerative colitis and Crohn’s while avoiding systemic PDE4 tolerability issues; positive Phase II results could add a new oral mechanism for IBD treatment.
Patients with moderate-to-severe ulcerative colitis or Crohn's disease (including those who have failed first-line advanced therapies), clinicians managing IBD, and researchers and investors following IBD drug development.
Palisade says Phase I showed favorable safety, intestinal (ileal and colonic) tissue exposure, and early clinical and endoscopic signals in small cohorts.
The ASCENTRA-UC program is a randomized, double-blind, placebo-controlled Phase IIb induction study planning ~204 UC patients with two active dose arms (15 mg and 30 mg once daily) versus placebo and a week-12 modified Mayo clinical remission primary endpoint.
ASCENTRA-CD is an open-label Phase II study of about 60 Crohn's patients with centrally read endoscopic response at week 12 as a primary objective measure; the company expects data readouts during 2027–early 2028.
What to watch for: whether the targeted prodrug design reduces systemic side effects historically seen with PDE4 inhibitors while achieving meaningful clinical and endoscopic benefit, and the timing and size of reported Phase II data.
Phase I cohort data described in the article were small and exploratory; ASCENTRA-UC is randomized and placebo-controlled while ASCENTRA-CD is open-label. Reported timelines and enrollment targets are company guidance and not study results.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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