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
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that
the first patient has been dosed in a global Phase 2 clinical trial
(NCT06380907) evaluating the efficacy and safety of the company’s
internally developed anti-IL-17 investigational therapy, ZL-1102,
for the treatment of chronic plaque psoriasis (CPP). ZL-1102 is a
novel human VH antibody fragment (Humabody®) targeting the IL-17
cytokine. Emphasizing its unique approach, ZL-1102 is being
developed as a topical treatment for mild-to-moderate CPP,
differentiating it from other anti-IL-17 products that target
moderate-to-severe forms of the disease through systemic
administration.
“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 Josh Smiley, President and Chief Operating Officer,
Zai Lab.
“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, M.D., President and Head of Global
Development, Neuroscience, Autoimmune & Infectious Diseases,
Zai Lab. “ZL-1102 exemplifies the innovative, patient-focused
R&D programs in our internal discovery and development
pipeline. We aim to bring this novel treatment option to patients
in need as quickly as possible.”
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. Zai Lab previously reported data from the
proof-of-concept study in patients with mild-to-moderate CPP in
which topical treatment with ZL-1102 showed a 45% relative
improvement compared to placebo in the local Psoriasis Area
Severity Index (PASI) score of the target lesion at four weeks, and
consistently higher responder rates over time compared to placebo
during and after the end of treatment.1
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.
About Zai Lab
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is an innovative,
research-based, commercial-stage biopharmaceutical company based in
China and the United States. We are focused 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. Our goal is to leverage our competencies and
resources to positively impact human health in China and
worldwide.
For additional information about Zai Lab, please visit
www.zailaboratory.com or follow us at
www.twitter.com/ZaiLab_Global.
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
China, and (6) other factors identified in our most recent annual
and quarterly reports and in other reports we have filed with the
U.S. Securities and Exchange Commission (SEC). We anticipate that
subsequent events and developments will cause our expectations and
assumptions to change, and we undertake no obligation to update or
revise any forward-looking statements, whether as a result of new
information, future events, or otherwise, except as may be required
by law. These forward-looking statements should not be relied upon
as representing our views as of any date subsequent to the date of
this press release.
Our SEC filings can be found on our website at
www.zailaboratory.com and the SEC’s website at www.sec.gov.
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. June 28, 2023.
https://pubmed.ncbi.nlm.nih.gov/37377276/
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version on businesswire.com: https://www.businesswire.com/news/home/20240522565853/en/
Investor Relations: Christine Chiou / Lina Zhang +1 (917)
886-6929 / +86 136 8257 6943 christine.chiou1@zailaboratory.com /
lina.zhang@zailaboratory.com
Media: Shaun Maccoun / Xiaoyu Chen +1 (857) 270-8854 /
+86 185 0015 5011 shaun.maccoun@zailaboratory.com /
xiaoyu.chen@zailaboratory.com
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