Halozyme Announces Positive Clinical Data of its High-Volume Auto-Injector Demonstrating Successful Rapid Subcutaneous Drug Delivery

Rhea-AI Summary

Halozyme announces positive results of a clinical study demonstrating successful subcutaneous administration of a biologic co-formulated with ENHANZE® in 30 seconds

Positive

• Subcutaneous administration of a 10 mL biologic co-formulated with ENHANZE® was successfully demonstrated in a clinical study using Halozyme's proprietary high-volume auto-injector
• The study achieved its primary endpoint, showing that 10 mL of a representative biologic product can be rapidly delivered using Halozyme's ENHANZE® and high-volume auto-injector technologies
• 96% of participants stated that they would be willing to receive the injection again

Negative

• None.

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") today announced 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. 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.

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.

FAQ

What is the main finding of the clinical study?

The clinical study demonstrated successful subcutaneous administration of a 10 mL biologic co-formulated with ENHANZE® in approximately 30 seconds using Halozyme's proprietary high-volume auto-injector.

What are the potential benefits of Halozyme's drug delivery technology?

Halozyme's ENHANZE® drug delivery technology has the potential to improve the patient experience by enabling rapid subcutaneous injection of high volumes of biologic products.

What were the results of the study in terms of participant feedback?

96% of participants stated that they would be willing to receive the injection again.

What is the primary endpoint of the study?

The primary endpoint of the study was achieved, with all subjects receiving the completed dose of the representative biologic product using Halozyme's high-volume auto-injector.

What is the potential clinical benefit of Halozyme's drug delivery technology?

Halozyme's ENHANZE® drug delivery technology has the potential to rapidly deliver large volume therapeutics subcutaneously with the potential for meaningful clinical benefits.