Zai Lab Starts Global Phase 2 Trial for ZL-1102 in Chronic Plaque Psoriasis

Zai Lab Limited has begun dosing the first patient in a global Phase 2 clinical trial for ZL-1102, an innovative treatment for chronic plaque psoriasis (CPP). ZL-1102 is distinct as it is the first human VH antibody fragment (Humabody®) designed for topical use targeting the IL-17 cytokine. Unlike existing treatments that primarily address moderate-to-severe cases through systemic administration, ZL-1102 is intended for mild-to-moderate CPP and is applied directly to affected skin areas.

Josh Smiley, President and COO of Zai Lab, emphasized the significance of this development, highlighting the company's commitment to pioneering novel therapies. Dr. Harald Reinhart, President and Head of Global Development for Neuroscience, Autoimmune & Infectious Diseases at Zai Lab, noted that ZL-1102 aims to minimize unnecessary tissue exposure and avoid systemic toxicity, which is a common issue with intravenous or subcutaneous treatments. This move underscores Zai Lab's dedication to patient-centric research and development, targeting a sizable patient demographic with less severe forms of CPP.

Psoriasis is a widespread condition affecting roughly 125 million individuals globally, with plaque psoriasis being the most prevalent form, accounting for 80% to 90% of cases. Within this group, 70% to 80% experience mild-to-moderate symptoms. Traditionally, systemic treatments, which include oral and injectable medications, are prescribed for more severe instances of psoriasis. Zai Lab's topical ZL-1102 offers a promising alternative for patients with less severe conditions.

Earlier data from a proof-of-concept study revealed that ZL-1102 achieved a 45% improvement in the Psoriasis Area Severity Index (PASI) score of the target lesion over four weeks compared to placebo. The study also observed higher responder rates over time, both during and after treatment.

The current Phase 2 clinical trial is a randomized, double-blind, vehicle-controlled study involving around 250 patients with mild-to-moderate CPP. Participants will receive topical treatment over a 16-week period. The primary goal is to assess the proportion of patients who achieve at least a 75% reduction in the modified PASI score from baseline by week 16. Secondary objectives include evaluating the efficacy throughout the treatment period, safety, tolerability, pharmacokinetics, and anti-drug antibody (ADA) responses.

ZL-1102, formulated as a hydrogel, benefits from its small molecular size which enhances its ability to penetrate psoriatic skin and bind effectively to its target. This potentially improves both safety and efficacy compared to larger monoclonal antibodies, making it a suitable option for a larger patient group with milder CPP.

Chronic plaque psoriasis is an autoimmune skin disorder marked by red, scaly patches. While it affects millions worldwide, most cases are mild-to-moderate and current treatment options often fall short in terms of efficacy or pose safety risks with prolonged use.

Zai Lab is a biopharmaceutical company operating in China and the United States, focusing on innovative therapies for oncology, autoimmune diseases, infectious diseases, and neuroscience. The company's aim is to address unmet medical needs and improve health outcomes globally.

In summary, Zai Lab's advancement of ZL-1102 into Phase 2 clinical trials marks a significant milestone in the treatment of mild-to-moderate chronic plaque psoriasis. By offering a topical alternative to systemic therapies, ZL-1102 has the potential to address a critical gap in current psoriasis treatment options.