Cure8 news brief
Cure8 news brief
Early Phase 1b results suggest PALI-2108 may produce rapid improvements on endoscopy and calprotectin in very small Crohn’s and UC cohorts, which could matter if later trials confirm benefit and safety. The findings are preliminary and need larger controlled studies.
Patients with Crohn’s disease and ulcerative colitis interested in emerging therapies; clinicians and researchers following PDE4-targeted drugs and IBD drug development; patients currently on biologics (some Crohn’s participants were on biologics).
These data are very early, from small (n=5) open-label Phase 1b cohorts without placebo controls, so they are hypothesis-generating rather than conclusive. Reported improvements include endoscopy scores and fecal calprotectin reductions, plus tissue-level pharmacology and exploratory biomarker changes.
Safety in these small cohorts was described as mild adverse events only, but larger controlled trials are needed to assess efficacy and safety. If you follow drug development, the Phase 2b UC trial (15 mg and 30 mg once daily versus placebo) and planned Crohn’s Phase 2a are the next steps that will provide more rigorous evidence.
The company’s pharmacokinetic findings — higher intestinal concentrations and plasma exposure above an estimated PDE4 inhibitory threshold at 30 mg — are offered as mechanistic support for once-daily dosing, but mechanistic/pharmacokinetic data do not by themselves prove clinical benefit.
These are small, short-duration, open-label cohorts (n=5 per cohort) without placebo controls; exploratory tissue and biomarker findings do not establish clinical antifibrotic effect or durable benefit. The Phase 2b and Phase 2a studies are ongoing/planned and will be needed to confirm these early signals.
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.