Palisade Bio, Inc. (PALI), a clinical-stage biopharmaceutical company, announced positive topline data from its Phase 1b clinical study evaluating PALI-2108 in 5 patients with Fibrostenotic Crohn's disease or FSCD.
Despite the positive data, PALI is down 5.06% at $1.69 in the pre-market.
Company Profile
Palisade develops next-generation oral PDE4 inhibitor prodrugs designed to improve pharmacology, tolerability, and convenience for patients with inflammatory and fibrotic diseases.
The firm's lead program, PALI-2108, is a once-daily oral PDE4 inhibitor prodrug designed to be selectively bioactivated in the ileum and colon to treat FSCD and Ulcerative colitis.
Trial Overview
The Phase 1b study enrolled five patients with FSCD and confirmed ileal stenosis and was designed to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of PALI-2108 following once-daily oral dosing over a 14-day treatment period.
Key Findings
The pharmacokinetic profile supported once-daily dosing with measurable systemic and tissue exposure.
Notably, patients achieved plasma drug concentrations above IC90 by the end of titration with doses as low as 20 mg daily.
Phase 1b data also demonstrated endoscopic improvement, with a 47.5% reduction in the Simple Endoscopic Score for Crohn's Disease (SES-CD).
40% of patients achieved endoscopic response, and 40% achieved endoscopic remission, according to the firm.
Also, PALI-2108 demonstrated favourable safety and tolerability, pharmacodynamic target engagement in ileal tissue, and encouraging early clinical activity signals in the five participating patients, according to the firm.
Upcoming Milestones
The trial results support the continued development of PALI-2108, and the company plans to initiate a Phase 2 study in a moderate-to-severe Crohn's disease population. Palisade Bio is also advancing towards a Phase 2 clinical study in Ulcerative colitis, designed to evaluate clinical remission, response and pharmacodynamic biomarkers over 12 weeks, with an extension phase assessing maintenance of remission. "If confirmed in larger studies, this targeted approach has the potential to represent an important advance in the treatment of fibrostenotic and luminal Crohn's disease," said Mitch Jones, President & Chief Medical Officer of Palisade Bio.
PALI has traded between $0.53 and $2.64 in the prior year. PALI closed Monday's trade at $1.78, down 11%.
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