Business
Update: Halozyme Announces Presentation of Positive Clinical Data of its High-Volume Auto-Injector Demonstrating Successful Rapid Subcutaneous Drug Delivery at 13th Annual PODD: Partnership Opportunities in Drug Delivery Conference
Study met primary end point and demonstrated successful subcutaneous administration of a 10 mL biologic co-formulated with ENHANZE® in 30 seconds using
About this update from Halozyme Therapeutics, Inc.
[{"type":"text","content":"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 \nSAN 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.\n\"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.\"\nIn 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.\nThe 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.\nData Highlights\n96% 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 inhibi...