Halozyme: ENHANZE Drug Delivery Technology Part Of Argenx's Positive Trial Of SC Efgartigimod In GMG

Halozyme Therapeutics, Inc. (HALO) announced Tuesday that its proprietary ENHANZE drug-delivery technology has been used in argenx's (ARGX) Phase 3 ADAPT-SC study of subcutaneous or SC efgartigimod (1000mg efgartigimod-PH20) to treat generalized myasthenia gravis or gMG.

argenx's Phase 3 ADAPT-SC study evaluating SC efgartigimod achieved the primary endpoint of total IgG reduction from baseline at day 29, demonstrating statistical non-inferiority to VYVGART (efgartigimod alfa-fcab) intravenous or IV formulation in gMG patients.

Based on these results, argenx plans to submit a Biologics License Application or BLA to the U.S. Food and Drug Administration (FDA) by the end of 2022.

SC efgartigimod is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE drug delivery technology.

Helen Torley, Halozyme president and chief executive officer, said, "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."

Halozyme's proprietary ENHANZE drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously, i.e., just under the skin.

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