Zai Lab Initiates Global Phase 2 Clinical Trial Evaluating ZL-1102 As a Topical Treatment for Chronic Plaque Psoriasis
This is the first compound in Zai’s portfolio of internally developed drugs to advance into Phase 2, demonstrating Zai’s global capabilities
Based on a proof-of-concept study, ZL-1102 is the first topical biologic to show penetration of psoriatic skin resulting in a clinical response
“This study marks an important milestone in Zai’s evolution and is a testament to our outstanding internal R&D team’s commitment to develop novel therapies to help patients across the globe,” 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,” said
Psoriasis affects about 125 million people worldwide; 80% to 90% of these individuals have plaque psoriasis and 70% to 80% of these cases are mild-to-moderate. Most systemic agents, i.e., oral and injectable medications, are prescribed for moderate-to-severe psoriasis.
The Phase 2 global clinical trial of ZL-1102 is a randomized, double-blind, vehicle-controlled, dose-ranging study in patients with mild-to-moderate CPP. In this 5-arm trial, approximately 250 patients will receive topical therapy for 16 weeks. The primary endpoint is the proportion of patients achieving modified PASI75, which is at least a 75% reduction in the modified PASI score from baseline, at week 16. The study will also determine the efficacy of different doses of ZL-1102 compared to placebo at the end of therapy. Secondary objectives include efficacy throughout the treatment period, safety, tolerability, pharmacokinetics and anti-drug antibody (ADA). For more information about this trial, please visit https://clinicaltrials.gov/study/NCT06380907.
About ZL-1102
ZL-1102 is an investigational, novel human VH antibody fragment, targeting the IL-17A cytokine, formulated as a hydrogel for topical use in the treatment of chronic plaque psoriasis. Due to its small size and other features unique to this class of molecules, ZL-1102 has improved target affinity and tissue penetration compared to full-sized monoclonal antibodies. With potentially improved safety and tolerability, this topical therapeutic may bring the potential of IL-17-targeted treatments to the large patient population with less severe CPP.
About Mild-to-Moderate Chronic Plaque Psoriasis
Plaque psoriasis is a common chronic, systemic, inflammatory autoimmune skin disease characterized by red patches and plaques with silvery scales on the skin. Psoriasis affects approximately 125 million people worldwide. Plaque psoriasis is the most common type, affecting 80%-90% of those with psoriasis. 70–80% of plaque psoriasis cases are mild-to-moderate, and marketed IL-17 inhibitors are currently not indicated for such cases. Topical therapies are the standard of care for treatment of mild-to-moderate disease. However, current treatment options provide limited efficacy or have safety concerns with long-term use.
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Zai Lab Forward-Looking Statements
This press release contains forward-looking statements relating to our future expectations, plans, and prospects, including, without limitation, statements regarding the possible benefits, safety, and efficacy of ZL-1102; the treatment of chronic plaque psoriasis; and risks and uncertainties associated with drug development and commercialization. All statements, other than statements of historical fact, included in this press release are forward-looking statements, and can be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would,” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact or guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. We may not actually achieve the plans, carry out the intentions, or meet the expectations or projections disclosed in our forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business initiatives, (3) the results of our clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) risks related to doing business in
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Notes:
(1) Sinclair, R., Sharifeh, S., Thackwray, S., Lickliter, J., Wu, J., Li, J., Qi, B., Bland-Ward, P., Reinhart, H. (2023). Topical application of a novel anti-interleukin-17A antibody fragment penetrates psoriasis skin: Results of a randomized, double-blind, placebo-controlled Phase IB study.
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