Cure8 news brief
FDA IND clearance lets PALI‑2108 move into a Phase 2 trial in Crohn’s disease, meaning the drug’s safety and efficacy will be formally tested in people with moderate-to-severe disease. The program is being run alongside an ulcerative colitis study, which could expand options if results are positive.
Patients with moderate-to-severe Crohn’s disease; IBD clinicians; clinical researchers; people following Palisade Bio’s drug development.
PALI-2108 is described as an oral PDE4 prodrug advancing from IND clearance into Phase 2 testing in Crohn’s disease; the program is intended to build a broader Phase 2 dataset across both Crohn’s and ulcerative colitis.
The ASCENTRA‑CD trial is reported as multicenter, open‑label, single‑arm, ~60 adults, with a 14‑day dose titration to a 30 mg once‑daily dose, 12‑week induction and 36‑week maintenance, and Week‑12 endoscopic response by SES‑CD as the primary endpoint.
Timing noted in the article: first patient dosing targeted Q1 2027 and primary efficacy readout targeted Q1 2028. This report is a company/market news item summarizing the IND clearance and planned trial; it does not present trial results.
Reported trial design, dose, endpoints, and timelines come from the company/market news summary; no clinical results are provided. IND clearance permits human testing but is not an approval of safety or efficacy.
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.
FDA clearance lets Palisade start a Phase 2 trial of PALI-2108 in moderate-to-severe Crohn’s disease, which could matter to patients and clinicians watching new oral treatments targeted to the lower intestine.
The Phase 2b results suggest the investigational TL1A drug duvakitug improved clinical and endoscopic outcomes versus placebo in both ulcerative colitis and Crohn’s disease, which could expand future treatment options if...
This press release reports phase 2 evidence that a new experimental antibody (duvakitug) showed clinical, endoscopic, and histologic improvements in both UC and Crohn’s disease, which could lead to a new treatment option...
