US-based biopharmaceutical company Palisade Bio has begun dosing subjects in the last cohort of its Phase Ia/b trial of PALI-2108 for treating ulcerative colitis (UC).
The single-centre trial’s primary objective is to assess the therapy’s tolerability, pharmacokinetics (PK) and safety in both healthy volunteers and UC patients.
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Palisade Bio noted that five Phase Ia single-ascending dose (SAD) cohorts and three out of four multiple-ascending dose (MAD) cohorts have previously been completed in the trial.
No serious adverse events (SAEs) or treatment-emergent adverse events (TEAEs) associated with lab values or electrocardiograms (ECGs) have been recorded in any of these cohorts.
Within the expected therapeutic dosage range, two MAD cohorts have been concluded, with no SAEs or TEAEs related to lab values or ECGs.
One cohort at these dose levels has shown tolerability with no TEAEs.
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By GlobalDataPalisade Bio chief medical officer Dr Mitch Jones said: “We are pleased with the initiation of the final MAD and UC cohorts in our Phase Ia/b study of PALI-2108.
“Of particular note is our successful transition from healthy volunteers to dosing our first cohort of patients with UC.
“The preliminary results from our SAD and MAD cohorts align with management’s expectations.
“We look forward to further evaluations, and we remain on track to report topline data in the first half of 2025.”
PALI-2108 is a phosphodiesterase-4 (PDE4) inhibitor that, unlike several other PDE4 inhibitors, has not previously been administered to humans.
To gain deeper insights into the therapy’s effects, Palisade Bio will use biomarkers such as serum high-sensitivity C-reactive protein (hsCRP), faecal calprotectin (CalPro), and histological assessments of colonic tissue.
Based in California, Palisade Bio is focused on developing therapeutics for inflammatory, fibrotic and autoimmune diseases.
The company has previously begun enrolment and dosing in a dose optimisation trial of LB1148, a broad-spectrum serine protease inhibitor.
