ZL-1102, Zai Lab’s Internally Developed Novel Human VH Antibody Fragment, Achieved Proof of Concept in Phase 1b Psoriasis Study
Topical therapy with ZL-1102 resulted in clinical improvement in local PASI score, erythema and scaling, target lesion size, and responder rates in patients with mild-to-moderate chronic plaque psoriasis; consistent improvement was seen over time
First study to demonstrate penetration of protein biological through psoriatic skin resulting in clinical response
Safety profile comparable to placebo
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In efficacy data in 51 evaluable patients,
- Treatment with ZL-1102 showed approximately a 45% relative improvement compared to placebo in the local Psoriasis Area Severity Index (PASI)1 score of the target lesion at four weeks. A trend of increasing efficacy compared to placebo was observed over time, and clinical benefit was maintained after the end of treatment up to six weeks.
- Anti-inflammatory effects were observed, with clear improvement in erythema of the target lesion up to four weeks, maintained after the end of treatment up to six weeks. Clinical improvement in scaling was also observed.
- ZL-1102 showed consistent clinical improvement in target lesion size (reduction in area) compared to an area increase in the placebo arm during the treatment period.
- ZL-1102 showed consistently higher responder rates over time compared to placebo up to four weeks and maintained after the end of treatment up to six weeks. The responder rate in this study was defined as the percentage of patients who achieved a ≥50% reduction compared to baseline in local PASI score of the target lesion, measured weekly.
Safety data in 53 evaluable patients showed:
- A benign safety and tolerability profile comparable to placebo, with treatment-emergent adverse events that were few in number and mild.
- Pharmacokinetic studies confirmed lack of systemic absorption of the compound.
“The proof-of-concept study was a multi-center trial conducted in Australia,” said Professor
“As 70–80% of plaque psoriasis cases are mild-to-moderate in severity, there is a strong rationale and patient need to develop a topical formulation of an IL-17-directed therapy that works directly on the lesion and avoids systemic exposure,” said
“Demonstrating proof-of-concept for ZL-1102 is an important step in Zai Lab’s development of a pipeline of internally developed products with global rights,” said Dr.
Note: (1) Local PASI score is a subset of overall PASI score, which does not include the area score. It is a compile of the sum score of erythema, scaling and induration, the maximum local PASI score is 12.
ZL-1102 is an investigational, novel human VH antibody fragment, targeting the IL-17A cytokine, which was generated by Crescendo Biologics’ proprietary Humabody® VH platform. It is 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, it 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.
ZL-1102 Proof-of-Concept Study
The proof-of-concept Phase 1b study had a two-part design. An open-label Part A evaluated the pharmacokinetics of single-dose ZL-1102 in six mild-to-moderate CPP patients. A double-blind, placebo-controlled, multi-center Part B assessed safety, pharmacokinetics, and efficacy of ZL-1102 in 53 patients with mild-to-moderate disease, randomized to topical ZL-1102 or placebo applied twice daily. The primary efficacy endpoint in Part B was the percentage change from baseline in local PASI score at day 29. Secondary endpoints included change from baseline of local PASI components, target lesion size, and responder rates by visit.
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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