August 07, 2025. — Leads & Copy — Palisade Bio, Inc. (Nasdaq: PALI) announced new data from its clinical program evaluating PALI-2108, a first-in-class, ileocolonic-targeted PDE4 inhibitor.
PALI-2108 demonstrated safety and tolerability with no serious adverse events. Its extended half-life and local bioactivation support once-daily dosing for ulcerative colitis (UC) and fibrostenotic Crohn’s disease (FSCD).
Colon tissue drug levels exceeded target thresholds 36 hours post-dose in a Phase 1a MAD cohort. The company is advancing toward an IND submission for a Phase 2 study in H1 2026.
The 7-day, open-label Phase 1b study enrolled five patients with moderate-to-severe UC, receiving titrated BID dosing of PALI-2108 (30 mg BID). Key highlights include: Achieved 100% (5/5) clinical response (≥30% or ≥3-point reduction in modified Mayo score with rectal bleeding subscore ≤1) Mean reduction of 62.8% in modified Mayo score (−4.0 point absolute change) One patient achieved clinical remission Fecal calprotectin decreased in 4/5 patients (mean 70%) Plasma hsCRP decreased by 15% Showed histologic improvement across multiple indices:
Dr. Mitchell Jones, Chief Medical Officer, noted the consistency across assessments, including a 100% clinical response rate, histologic improvements, and reduced tissue lymphocytes, reflecting immunologic resolution.
JD Finley, CEO of Palisade Bio, stated that the early clinical activity, targeted delivery, dose flexibility, potential for once-daily oral dosing, and favorable safety profile position PALI-2108 as a potentially best-in-class oral therapy for UC patients.
For more information about the Phase 1a/b clinical study, visit clinicaltrials.gov and reference identifier NCT06663605.
Jenene Thomas, JTC Team, LLC, 908-824-0775, PALI@jtcir.com
Source: Palisade Bio
