Halozyme Therapeutics Inc. (NASDAQ: HALO) has announced findings from argnex’s third phase ADAPT-SC trial evaluating subcutaneous efgartigimod for the generalized myasthenia gravis treatment attained the primary goal of total IgG reduction from baseline after 29 Days. In addition, findings showed statistical non-inferiority to VYVGART intravenous formulation in gMG patients. As a result, based on the results, argenx has indicated that it plans to submit a BLA to the US FDA by the end of 2022.
Halozyme delighted with another patient generating strong study results
CEO and President Helen Torley, “We are excited for the potential of the subcutaneous form of efgartigimod to offer patients suffering from generalized myasthenia gravis an additional treatment option for this debilitating autoimmune disease. We are pleased to see another partner generate strong pivotal trial results with a therapy utilizing our ENHANZE® technology. Subcutaneous efgartigimod has the potential to be the first of our wave 3 products to launch.”
Argenx will confirm when it will be an investors call detailing data from the ADAPT-SC study that will be submitted for presentation at a future meeting.
Haozyme’s proprietary ENHANZE based on recombinant human hyaluronidase enzyme
Halozyme’s novel ENHANZE drug-delivery tech is based on the patented recombinant human hyaluronidase enzyme. rHuPH20 has shown the potential to do away with traditional limitations on the volume of biologics that can be given subcutaneously. By utilizing rHuPH20, part of the compounds and biologics that are administered intravenously should instead be given intravenously. Also, ENHANZE could benefit subcutaneous biologics by minimizing the need for several injections. In addition, the delivery has been demonstrated in trials that it can minimize healthcare practitioner time needed for administration and minimize the time for drug administration.
ENHANZE technology can minimize hours of treatment to minutes, and the company’s commercially-validated solution has impacted more than 600,000 patient lives through five products in over 100 global markets. In addition, the company and its partners are advancing several therapeutic programs that will deliver innovat8ive treatments to improve the lives of patients across the globe. The novel rHuPH20 forms the basis for ENHANZE tech.
