Shanghai, China – Zai Lab Limited has commenced a global phase 2 clinical trial to evaluate the efficacy and safety of ZL-1102, a novel anti-IL-17 investigational therapy, for the treatment of chronic plaque psoriasis (CPP). The first patient was dosed on Friday.
ZL-1102 is a groundbreaking human VH antibody that targets the IL-17 cytokine. This treatment is unique as it is being developed as a topical solution for mild to moderate CPP, unlike existing therapies that address moderate to severe cases through systemic administration. Zai Lab highlights the limitations of current treatments for mild to moderate psoriasis, which often lack efficacy or present safety concerns over long-term use.
“ZL-1102 is pioneering as the first IL-17 targeted topical treatment for patients with less severe forms of CPP. It is designed for direct application to psoriatic skin lesions, which could minimize unnecessary tissue exposure and avoid systemic toxicity associated with intravenous or subcutaneous therapies,” said Dr. Harald Reinhart, President and Head of Global Development for Neuroscience, Autoimmune, and Infectious Diseases at Zai Lab. “This reflects our commitment to innovative, patient-focused research within our discovery and development pipeline. Our goal is to expedite the delivery of this novel treatment to patients in need.”
The phase 2 trial will involve approximately 250 patients undergoing a 16-week topical treatment regimen. The primary aim is for a majority of patients to achieve a modified PASI 75. The trial will also compare the efficacy of various doses of ZL-1102 to a placebo, alongside evaluating secondary objectives such as safety, tolerability, pharmacokinetics, and anti-drug antibody responses.
Globally, 125 million people suffer from psoriasis, with 80% to 90% having plaque psoriasis. Of these, 70% to 80% are classified as mild to moderate. Topical therapies are the standard treatment for mild to moderate cases, yet current IL inhibitors are not approved for these patients.
Previous proof-of-concept studies by Zai Lab demonstrated a 45% improvement in the psoriasis area severity index (PASI) score for the target lesion after 4 weeks of treatment with ZL-1102 compared to a placebo. Consistently higher responder rates were observed during and after the treatment period.
“This trial is a significant milestone for Zai Lab, underscoring our research and development team’s dedication to creating novel therapies for patients worldwide,” stated Josh Smiley, President and Chief Operating Officer of Zai Lab.
ZL-1102 is the first internally developed drug by Zai Lab to progress to phase 2 trials. It is the first topical biologic shown to penetrate psoriatic skin effectively, leading to a clinical response. Zai Lab is committed to discovering, developing, and commercializing innovative treatments for medical conditions with substantial unmet needs in oncology, autoimmune disorders, infectious diseases, and neuroscience.
The study (NCT06380907) requires participants to be at least 18 years old with a clinical diagnosis of psoriasis vulgaris for a minimum of 6 months. Participants must be willing to comply with study procedures, have an investigator’s global assessment (IGA) score of 2 or higher out of 5, and have 3% to 15% body surface area (BSA) affected, excluding the head.
For further information, visit the official Zai Lab website.
