Study met primary end point and demonstrated
successful subcutaneous administration of a 10 mL biologic
co-formulated with ENHANZE® in 30 seconds using
Halozyme's proprietary high-volume auto-injector
SAN
DIEGO, Oct. 16, 2023 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") will present
the positive results of a clinical study demonstrating subcutaneous
administration of 10 mL of a representative biologic product
co-formulated with its ENHANZE® drug delivery
technology, in approximately 30 seconds, at the 13th
Annual PODD: Partnership Opportunities in Drug Delivery
Conference. In the study, the biologic was delivered with
Halozyme's proprietary high-volume auto-injector (HVAI) in healthy
volunteers. The injection was delivered successfully to all 23
participants and was well tolerated.
"To our knowledge, this is the first clinical study of its
kind," said Mike LaBarre, chief
technical officer of Halozyme. "Traditional subcutaneous
auto-injector delivery methods are typically limited to volumes
less than 2 mL or require long delivery times at slow rates for
higher volumes. By enabling rapid subcutaneous injection of high
volumes of biologic products, our ENHANZE drug delivery technology
in combination with our proprietary HVAI has the potential to
improve the patient experience for multiple therapies."
In the study, a representative biologic, immunoglobulin 10%, was
delivered to 23 healthy volunteers. The primary endpoint of
the study was achieved with all subjects receiving the completed
dose with HVAI, demonstrating that 10 mL of a representative
biologic product can be rapidly delivered using Halozyme's
ENHANZE® and HVAI technologies.
The data will be presented in an oral presentation titled
"Demonstrating High-Volume Auto-Injector Delivery of 10 mL in
~30 sec: Halozyme Clinical Study HALO-104-105" on Tuesday, October 17 at 10:35am ET.
Data Highlights
- 96% of participants stated that they would be willing to
receive the injection again.
- 90% of participants indicated feeling either no pain or mild
pain immediately after injection.
- Erythema, swelling, and induration were generally minimal to
mild and resolved by 90 minutes or less.
Biologics delivered subcutaneously through auto-injectors are
typically restricted to doses of 1-2 mL. This limitation is caused
by hyaluronan, a molecule that inhibits fluid dispersion in the
subcutaneous space. Halozyme's ENHANZE® drug delivery
technology is based on a proprietary recombinant human
hyaluronidase PH20 (rHuPH20), an enzyme that locally degrades
hyaluronan in the subcutaneous space. This temporarily increases
the permeability of the tissue under the skin, allowing space for
the biologic to enter, enabling it to be rapidly dispersed and
absorbed into the bloodstream.
"These results support our continued dedication to providing
innovative drug delivery options to patients," said Helen Torley, chief executive officer of
Halozyme. "Our ENHANZE drug delivery and HVAI technologies have the
potential to rapidly deliver large volume therapeutics
subcutaneously with the potential for meaningful clinical
benefits."
Halozyme's HVAI is available to partners for clinical use.
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® drug delivery 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
seven 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
in this press release include forward-looking statements including,
without limitation, statements concerning the Company's development
and clinical trial results of a high volume auto-injector and
statements concerning the Company's ENHANZE® drug
delivery technology (including statements regarding use in
combination with the Company's high volume auto-injector) including
the possible 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, facilitating more rapid delivery and
administration of higher volumes of injectable medications through
subcutaneous delivery and certain other benefits of
ENHANZE® including improving the treatment experience
for patients. Forward-looking statements regarding the Company's
ENHANZE® business may include potential growth driven by
our partners' development and commercialization efforts, including
the use of the Company's high-volume auto-injector and
ENHANZE® drug delivery technologies to facilitate rapid
delivery of large volume therapeutics subcutaneously. These
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 and involve risk and
uncertainties that could cause actual results to differ materially
from those in the forward-looking statements. Actual results could
differ materially from the expectations contained in these
forward-looking statements as a result of several factors,
including risks that clinical trial results may not be replicated,
unexpected results or delays in the development and growth of the
Company's high volume auto-injector business, or in the
development, regulatory review or commercialization of the
Company's potential high volume auto-injector partnered products,
regulatory approval requirements, unexpected adverse events or
patient outcomes and competitive conditions. These and other
factors that may result in differences are discussed in greater
detail in the Company's most recent Annual Report on Form 10-K and
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission.
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
Shannia Coley
CG Life
443-471-6830
scoley@cglife.com
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SOURCE Halozyme Therapeutics, Inc.