Zai Lab has dosed the first subject in a Phase II clinical trial of ZL-1102, an investigational therapy aimed at treating chronic plaque psoriasis (CPP).
The randomised, global, double-blind, vehicle-controlled, dose-ranging trial is designed to assess the efficacy and safety of ZL-1102 as a topical treatment.
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Approximately 250 patients will be enrolled across five arms to receive the topical treatment over a 16-week period.
The proportion of subjects achieving a 75% reduction in the modified PASI score from baseline at week 16, known as modified PASI75, is the primary endpoint of the trial.
The trial will also evaluate the efficacy of varying doses of ZL-1102 versus placebo.
Monitoring efficacy throughout the treatment period, tolerability, safety, pharmacokinetics, and anti-drug antibody (ADA) development include the secondary objectives.
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By GlobalDataZL-1102 is a human VH antibody fragment (Humabody) targeting the interleukin (IL)-17 cytokine.
Zai Lab Neuroscience, Autoimmune & Infectious Diseases Global Development head and president Harald Reinhart said: “ZL-1102 is the first IL-17 targeted topical treatment in development for patients with less severe forms of CPP. Formulated to be applied directly to psoriatic skin lesions, we hope it can bypass unnecessary tissue exposure and avoid systemic toxicity commonly associated with intravenous or subcutaneous therapies.
“ZL-1102 exemplifies the innovative, patient-focused R&D programs in our internal discovery and development pipeline. We aim to bring this novel treatment option to patients in need as quickly as possible.”
The company reported positive topline data from the Phase Ib trial of a topical formulation of ZL-1102 in mild-to-moderate CPP patients in October 2021.
