US-based biopharmaceutical company Palisade Bio has begun the multiple ascending dose (MAD) cohorts of its ongoing Phase Ia/b trial of PALI-2108 for treating ulcerative colitis (UC).
These cohorts were launched following the completion of all five of the trial’s planned single ascending dose (SAD) cohorts.
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Initial data from the SAD cohorts, which assessed doses from 15mg to 450mg, suggest that the therapy is well-tolerated at all levels.
No treatment-related dose reductions, serious adverse events or laboratory abnormalities were reported, while the absence of electrocardiogram abnormalities or other serious safety concerns has given the therapy a ‘favourable’ safety profile.
Pharmacokinetic (PK) analysis of PALI-2108 demonstrated the drug’s extended-release and delayed-release characteristics, ensuring sustained, dose-dependent drug exposure with increased local concentrations in the colon, crucial for UC treatment.
Palisade Bio chief medical officer Dr Mitch Jones said: “We are excited to move from the SAD to the MAD portion of our Phase Ia/b study of PALI-2108, a significant milestone that brings us one-step closer to delivering an innovative, safe, and effective treatment option for UC patients.
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By GlobalData“The preliminary data from the SAD cohorts have reinforced our confidence in PALI-2108’s safety profile, and we remain on track to report topline data in the first half of 2025.”
The Phase Ia/b study’s primary goal is to assess the therapy’s tolerability, PK and safety in healthy volunteers, as well as its safety, tolerability, PK and pharmacodynamics (PD) in UC subjects.
Unlike other phosphodiesterase-4 inhibitors on the market, PALI-2108 is a new chemical entity and is being administered to humans for the first time.
To gain insights into the therapy’s effects, biomarkers such as serum high-sensitivity C-reactive protein and faecal calprotectin will be used.
Palisade Bio previously held a dose optimisation trial of LB1148, a broad-spectrum serine protease inhibitor designed to reduce intestinal damage.
