Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) and argenx SE
(Euronext & Nasdaq: ARGX) today announced positive topline
results from the ADHERE study evaluating VYVGART Hytrulo
(efgartigimod alfa and hyaluronidase-qvfc) in adults with chronic
inflammatory demyelinating polyneuropathy (CIDP). The study met its
primary endpoint (p=0.000039), demonstrating a significantly lower
risk of relapse with VYVGART Hytrulo compared to placebo. Detailed
data from ADHERE will be presented at an upcoming medical meeting.
ADHERE Highlights
- Primary endpoint met (p=0.000039);
VYVGART Hytrulo demonstrated 61% reduction (HR: 0.39 95% CI: 0.25;
0.61) in the risk of relapse versus placebo
- 67% of patients in open-label Stage
A demonstrated evidence of clinical improvement (ECI), indicating
that IgG autoantibodies play a significant role in the underlying
biology of CIDP
- Safety and tolerability profile
consistent with confirmed safety profile of VYVGART
- 91% (226/249) of eligible patients
continued to the ADHERE-Plus open-label extension study
“CIDP is a rare chronic immune-mediated
peripheral neuropathy characterized by weakness and sensory
dysfunction in the limbs, significantly impacting the daily life
and work of patients,” said Dr. Chongbo Zhao, M.D., Ph.D., Deputy
Director of Department of Neurology, Huashan Hospital Affiliated to
Fudan University, Director of Working Group of Huashan Rare Disease
Center. “Currently, intravenous immunoglobulin (IVIg), plasma
exchange (PLEX), and glucocorticoids are the main treatments used
during the induction and maintenance phases. However, the
accessibility and convenience of IVIg and PLEX are limited, and
glucocorticoids have significant side effects, leaving urgent needs
for treatment options that are more effective and safe. We are
excited about the therapeutic potential of VYVGART Hytrulo, a
promising treatment that may become a therapeutic alternative for
CIDP in China.”
“The positive ADHERE trial data provides strong
clinical evidence that VYVGART Hytrulo meaningfully improves and
stabilizes disease symptoms in CIDP patients with a favorable
safety profile and a simple route of administration,” said Dr.
Harald Reinhart, President and Head of Global Development,
Neuroscience, Autoimmune & Infectious Diseases, Zai Lab. “We
are proud to have contributed to the ADHERE study and are looking
forward to working with our partner to bringing this therapy to
CIDP patients in China.”
Detailed ADHERE Results
ADHERE is the largest clinical trial of CIDP
patients to date, enrolling adults who were treatment naïve (not on
active treatment within the past six months) or currently on
immunoglobulin therapy or corticosteroids. The trial consisted of a
run-in period where current treatment was stopped followed by an
open-label Stage A, after which responders to VYVGART Hytrulo
advanced to a randomized, placebo-controlled Stage B.
322 patients enrolled in Stage A and received
treatment with VYVGART Hytrulo.
- 67% (214/322) demonstrated evidence
of clinical improvement (ECI) after a run-in withdrawal period
based on the Inflammatory Neuropathy Cause and Treatment (INCAT)
Disability Score, the Inflammatory Rasch-built Overall Disability
Scale (I-RODS) or grip strength
- 70% (214/304) demonstrated ECI
excluding patients ongoing in Stage A at the time of the 88th event
who did not have the full opportunity to achieve a response
- 78% (214/275) demonstrated ECI in a
sensitivity analysis of patients who received at least four
injections to reach the full IgG-lowering effect of VYVGART
Hytrulo
- Response rates similar across all
prior CIDP medication subgroups with consistent efficacy on INCAT,
I-RODS and grip strength
221 responders from Stage A entered Stage B,
where the primary endpoint was the relative risk of relapse based
on time to relapse on the INCAT Disability Score.
- VYVGART Hytrulo significantly
reduced the risk of CIDP relapse compared to placebo
- Primary endpoint was met
(p=0.000039); VYVGART Hytrulo demonstrated a 61% reduction (HR:
0.39 95% CI: 0.25; 0.61) in the risk of relapse compared to placebo
based on time to the first adjusted INCAT deterioration of ≥1
point
- VYVGART Hytrulo patients had a
lower relapse rate compared to placebo at Week 24 (26% versus 54%)
and Week 48 (34% versus 60%)
- VYVGART Hytrulo patients
experienced longer time to relapse compared to those on placebo
with a rapid separation of the Kaplan–Meier curves beginning at
Week 4 and sustained through Week 48
- VYVGART Hytrulo patients
demonstrated a clinically meaningful mean improvement of 7.7 points
on I-RODS and 12.3kPa on grip strength in Stage A. This clinically
meaningful benefit was maintained in Stage B by treated patients
and lost in placebo patients
- Clinical benefit observed across
all efficacy scales and patient subgroups, regardless of prior
therapy
VYVGART Hytrulo was well-tolerated with a safety
profile that is consistent with prior clinical trials and the known
profile of VYVGART. The most frequent treatment-related adverse
event was injection site reactions (ISRs), which occurred in a
lower percentage of patients than previous VYVGART Hytrulo trials
(20% in Stage A; 10% in Stage B). All ISRs were mild to moderate
and resolved over time.
Zai Lab has an exclusive license agreement with
argenx for the development and commercialization of VYVGART and
VYVGART Hytrulo in Greater China. Through this agreement, Zai Lab
dosed the first patient in the Greater China portion of the global
registrational ADHERE trial in November 2021, and contributed a
significant number of patients into this trial.
About ADHERE Trial Design
The ADHERE trial was a multicenter, randomized,
double-blind, placebo-controlled trial evaluating VYVGART® Hytrulo
(efgartigimod alfa and hyaluronidase-qvfc) for the treatment of
chronic inflammatory demyelinating polyneuropathy (CIDP). ADHERE
enrolled 322 adult patients with CIDP who were treatment naïve (not
on active treatment within the past six months or newly diagnosed)
or being treated with immunoglobulin therapy or corticosteroids.
The trial consisted of an open-label Stage A followed by a
randomized, placebo-controlled Stage B. In order to be eligible for
the trial, the diagnosis of CIDP was confirmed by an independent
panel of experts. Patients entered a run-in stage, where any
ongoing CIDP treatment was stopped and in order to be eligible for
Stage A had to demonstrate active disease, with clinically
meaningful worsening on at least one CIDP clinical assessment tool,
including INCAT, I-RODS, or mean grip strength. Treatment naïve
patients were able to skip the run-in period with proof of recent
worsening. To advance to Stage B, patients needed to demonstrate
evidence of clinical improvement (ECI) with VYVGART Hytrulo. ECI
was achieved through improvement of the INCAT score, or improvement
on I-RODS or mean grip strength if those scales had demonstrated
worsening during the run-in period. In Stage B, patients were
randomized to either VYVGART Hytrulo or placebo for up to 48 weeks.
The primary endpoint was measured once 88 total relapses or events
were achieved in Stage B and was based on the hazard ratio for the
time to first adjusted INCAT deterioration (i.e. relapse). After
Stage B, all patients had the option to roll-over to an open-label
extension study to receive VYVGART Hytrulo.
About Chronic Inflammatory Demyelinating
Polyneuropathy
Chronic inflammatory demyelinating
polyneuropathy (CIDP) is a rare and serious autoimmune disease of
the peripheral nervous system. Although confirmation of disease
pathophysiology is still emerging, there is increasing evidence
that IgG antibodies play a key role in the damage to the peripheral
nerves. People with CIDP experience fatigue, muscle weakness and a
loss of feeling in their arms and legs that can get worse over time
or may come and go. These symptoms can significantly impair a
person's ability to function in their daily lives. Without
treatment, one-third of people living with CIDP will need a
wheelchair.
About CIDP in China
The prevalence of CIDP in China is estimated at
50,000 patients.1 Current treatment options are primarily
corticosteroids and intravenous immunoglobulin (IVIg), with plasma
exchange (PLEX) generally reserved for refractory patients. There
is limited access to PLEX or IVIg in many parts of the world,
including China. As most patients require treatment for an extended
period of time there remains a significant unmet need for alternate
treatment options that are effective, well-tolerated, and
convenient for patients with CIDP in China.
1 Chronic inflammatory demyelinating
polyneuropathy and diabetes, 2020.
About VYVGART®
Hytrulo
VYVGART Hytrulo is a subcutaneous combination of efgartigimod
alfa, a human IgG1 antibody fragment marketed for intravenous use
as VYVGART®, and recombinant human hyaluronidase PH20 (rHuPH20),
Halozyme’s ENHANZE® drug delivery technology to facilitate
subcutaneous injection delivery of biologics. In binding to the
neonatal Fc receptor (FcRn), VYVGART Hytrulo results in the
reduction of circulating IgG. It is the first-and-only approved
FcRn blocker administered by subcutaneous injection.
VYVGART Hytrulo is the proprietary name in the U.S. for
subcutaneous efgartigimod alfa and recombinant human hyaluronidase
PH20. It may be marketed under different proprietary names
following approval in other regions.
Zai Lab has an exclusive license agreement with argenx to
develop and commercialize efgartigimod in mainland China, Hong
Kong, Macau, and Taiwan (Greater China).
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 diseases, 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, including our
products, business activities and partnerships, research, and other
events or developments, 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 about
future expectations, plans, and prospects for Zai Lab, including,
without limitation, statements regarding the prospects of and plans
for development and commercialization of efgartigimod in Greater
China, the safety and efficacy of efgartigimod, and the potential
treatment of patients with chronic inflammatory demyelinating
polyneuropathy in Greater China. These forward-looking statements
may contain 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. 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 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) the effects of the novel coronavirus (COVID-19)
pandemic on our business and results of operations, (6) risks
related to doing business in China, and (7) 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.
For more information, please contact:
Investor Relations: Christine
Chiou / Lina Zhang+1 (917) 886-6929 / +86 136 8257
6943christine.chiou1@zailaboratory.com / lina.zhang@zailaboratory.com
Media: Shaun Maccoun / Xiaoyu Chen+1 (415)
317-7255 / +86 185 0015
5011shaun.maccoun@zailaboratory.com/xiaoyu.chen@zailaboratory.com
Source: Zai Lab Limited
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