SAN
DIEGO, July 17, 2023 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that
argenx reported positive topline data from the ADHERE study
evaluating VYVGART® Hytrulo (efgartigimod alfa and
hyaluronidase-qvfc) with ENHANZE® 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 the study will be presented at an upcoming medical
meeting.
ADHERE Data 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
- Safety and tolerability profile consistent with confirmed
safety profile of VYVGART®
"We are delighted with the strong data in CIDP and what it can
mean for patients living with this challenging condition. Following
the recent approval in generalized myasthenia gravis, this is the
second successful outcome for VYVGART Hytrulo this year, with two
additional study readouts for ITP and pemphigus expected in the
fourth quarter," said Dr. Helen
Torley, president and chief executive officer of Halozyme.
"We are pleased that our partnership with argenx continues to
support our shared mission to improve the lives of people suffering
from severe autoimmune diseases."
About ADHERE Trial Design
The Phase 2 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 for ≥6 months) 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 enter Stage A and receive VYVGART Hytrulo, 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 they 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) to VYVGART
Hytrulo. ECI was achieved through improvement of 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 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 Halozyme Therapeutics, Inc.
Halozyme is a biopharmaceutical company bringing disruptive
solutions to significantly improve patient experiences and outcomes
for emerging and established therapies. As the innovators of the
ENHANZE® technology with the proprietary enzyme rHuPH20, Halozyme's
commercially-validated solution is used to facilitate the delivery
of injected drugs and fluids in order to reduce the treatment
burden to patients. Having touched more than 700,000 patient lives
in post-marketing use in six commercialized products across more
than 100 global markets, Halozyme has licensed its ENHANZE®
technology to leading pharmaceutical and biotechnology companies
including Roche, Takeda, Pfizer, AbbVie, Eli Lilly, Bristol-Myers
Squibb, Alexion, argenx, Horizon Therapeutics, ViiV Healthcare and
Chugai Pharmaceutical.
Halozyme also develops, manufactures and commercializes, for
itself or with partners, drug-device combination products using its
advanced auto-injector technology that are designed to provide
commercial or functional advantages such as improved convenience
and tolerability, and enhanced patient comfort and adherence. The
Company has a commercial portfolio of proprietary products
including XYOSTED®, TLANDO® and NOCDURNA® and partnered commercial
products and ongoing product development programs with several
pharmaceutical companies including Teva Pharmaceutical, Pfizer and
Idorsia Pharmaceuticals.
Halozyme is headquartered in San
Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations
facility.
For more information visit www.halozyme.com and
connect with us on LinkedIn and Twitter.
Safe Harbor Statement
In addition to historical information, the statements set forth
above include forward-looking statements including, without
limitation, statements concerning the possible activity, benefits
and attributes of ENHANZE®, the possible method of action of
ENHANZE®, its potential application to aid in the dispersion and
absorption of other injected therapeutic drugs, and statements
concerning certain other potential benefits of ENHANZE® including
facilitating more rapid delivery of injectable medications through
subcutaneous delivery and potentially lowering the treatment burden
for patients and broadening the treatment options for the
indication referred to in this press release. These forward-looking
statements also include statements regarding the product
development efforts of Halozyme's ENHANZE® partner, potential
additional data readouts, indications and eligible patients for the
ENHANZE® co-formulated treatment referred to in this press release.
These forward-looking statements involve risks and uncertainties
that could cause actual results to differ materially from those in
the forward-looking statements. The forward-looking statements are
typically, but not always, identified through use of the words
"believe," "enable," "may," "will," "could," "intends," "estimate,"
"anticipate," "plan," "predict," "probable," "potential,"
"possible," "should," "continue," and other words of similar
meaning. Actual results could differ materially from the
expectations contained in forward-looking statements as a result of
several factors, including uncertainties concerning whether new
ENHANZE® collaborative products are ultimately developed, approved
or commercialized or whether additional indications for the
ENHANZE® co-formulated treatment referred to in this press release
will be approved, unexpected results or delays in development and
regulatory review, unexpected regulatory approval requirements,
unexpected adverse events or patient outcomes from being treated
with the ENHANZE® co-formulated treatment referred to in this press
release, and competitive conditions. These and other factors that
may result in differences are discussed in greater detail in
Halozyme's most recent Annual and Quarterly Reports filed with the
Securities and Exchange Commission. Except as required by law,
Halozyme undertakes no duty to update forward-looking statements to
reflect events after the date of this release.
Contacts
Tram Bui
VP, Investor Relations and Corporate Communications
609-359-3016
tbui@halozyme.com
Dawn Schottlandt
Argot Partners
212-600-1902
Halozyme@argotpartners.com
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SOURCE Halozyme Therapeutics, Inc.