Phase 2 Trial of ZL-1102 for Psoriasis Begins

Image Credit: © Ольга Тернавская - stock.adobe.com

Zai Lab Limited announced Friday that the first patient has been dosed in a global phase 2 clinical trial assessing the efficacy and safety of ZL-1102 (Humabody; Zai Lab), the company’s anti-IL-17 investigational therapy, for chronic plaque psoriasis (CCP).¹

ZL-1102 is a novel human VH antibody targeting the IL-17 cytokine. It is being developed as a topical treatment for mild to moderate CCP, differing from other products that target moderate to severe cases through systemic treatment. According to Zai Lab, current treatment options for mild to moderate cases provide limited efficacy or have safety concerns with long-term use.

“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,” said Harald Reinhart, MD, president and head of global development, neuroscience, autoimmune and infectious diseases at Zai Lab, in a press release. “ZL-1102 exemplifies the innovative, patient-focused research and development programs in our internal discovery and development pipeline. We aim to bring this novel treatment option to patients in need as quickly as possible.”

During the dose-ranging phase 2 trial, Zai Lab estimates approximately 250 patients will receive topical therapy for 16 weeks with the hope of most achieving modified PASI 75. The study will also determine the efficacy of different doses of ZL-1102 compared to placebo at the end of therapy. The company noted secondary objectives including efficacy throughout treatment, safety, tolerability, pharmacokinetics and anti-drug antibody.

According to Zai Lab, 125 million people worldwide are affected by psoriasis. Of those affected, they note 80% to 90% have plaque psoriasis, with 70% to 80% of these cases being mild to moderate. Although topical therapies are the standard of care for treatment of mild to moderate disease severity, Zai Lab notes marketed IL inhibitors are currently not indicated for such cases.

Ina proof-of-concept study, Zai Lab previously reported data showing a 45% relative improvement for those treated with ZL-1102 compared to placebo in psoriasis area severity index (PASI) score of the target lesion at 4 weeks. They reported observing consistently higher responder rates over time compared to placebo during and after the end of treatment.²

“This study marks an important milestone in Zai’s evolution and is a testament to our outstanding internal research and development team’s commitment to develop novel therapies to help patients across the globe,” said Josh Smiley, president and chief operating officer of Zai Lab, in a press release.

ZL-1102 is the first compound in the company's portfolio of internally developed drugs to move onto phase 2. Based on the previously reported proof-of-concept study, Zai Lab reported that ZL-1102 is the first topical biologic to show penetration of psoriatic skin resulting in a clinical response. The company focuses on “discovering, developing and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, autoimmune disorders, infectious disease and neuroscience.”

To be included in the study (NCT06380907), participants must be at least 18 years old, have a clinical diagnosis of psoriasis vulgaris of at least 6 months duration, and be willing to comply with study procedures. The researchers ask that participants have an investigator's global assessment (IGA) greater than or equal to 2 out of 5 and an affected body surface area (BSA) of 3% to 15% excluding the head.³ 

References

1. Zai Lab initiates global phase 2 clinical trial evaluating ZL-1102 as a topical treatment for chronic plaque psoriasis. News Release. Business Wire. May 22, 2024. Accessed May 28, 2024. https://www.businesswire.com/news/home/20240522565853/en/ 
2. Sinclair R, Sharifeh S, Thackwray S, et al. Topical application of a novel anti-interleukin-17A antibody fragment penetrates psoriatic skin: results of a randomised, double-blind, placebo-controlled phase 1b study. Exp Dermatol. 2023;32(9):1538-1545. doi:10.1111/exd.14861
3. Phase 2 study of ZL-1102 in patients with chronic plaque psoriasis. Clinicaltrials.gov. April 26, 2024. Accessed May 28, 2024. https://clinicaltrials.gov/study/NCT06380907.