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Positive Topline Data Reported from argenx's ADHERE Study of VYVGART® Hytrulo with Halozyme's ENHANZE® Drug Delivery Technology in Patients with Chronic Inflammatory Demyelinating Polyneuropathy
SAN DIEGO, July 17, 2023 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that argenx reported positive topline data
About this update from Halozyme Therapeutics, Inc.
[{"type":"text","content":"SAN DIEGO, July 17, 2023 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (\"Halozyme\") today announced that argenx reported positive topline data from the ADHERE study evaluating VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) with ENHANZE® in adults with chronic inflammatory demyelinating polyneuropathy (CIDP). The study met its primary endpoint (p=0.000039) demonstrating a significantly lower risk of relapse with VYVGART® Hytrulo compared to placebo. Detailed data from the study will be presented at an upcoming medical meeting.\nADHERE Data Highlights \nPrimary endpoint met (p=0.000039); VYVGART® Hytrulo demonstrated 61% reduction (HR: 0.39 95% CI: 0.25; 0.61) in the risk of relapse versus placeboSafety and tolerability profile consistent with confirmed safety profile of VYVGART®\"We are delighted with the strong data in CIDP and what it can mean for patients living with this challenging condition. Following the recent approval in generalized myasthenia gravis, this is the second successful outcome for VYVGART Hytrulo this year, with two additional study readouts for ITP and pemphigus expected in the fourth quarter,\" said Dr. Helen Torley, president and chief executive officer of Halozyme. \"We are pleased that our partnership with argenx continues to support our shared mission to improve the lives of people suffering from severe autoimmune diseases.\"\nAbout ADHERE Trial Design\nThe Phase 2 ADHERE trial was a multicenter, randomized, double-blind, placebo-controlled trial evaluating VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP). ADHERE enrolled 322 adult patients with CIDP who were treatment naïve (not on active treatment for ≥6 months) or being treated with immunoglobulin therapy or corticosteroids. The trial consisted of an open-label Stage A followed by a randomized, placebo-controlled Stage B. In order to enter Stage A and receive VYVGART Hytrulo, the diagnosis of CIDP was confirmed by an independent panel of experts. Patients entered a run-in stage, where any ongoing CIDP treatment was stopped and they had to demonstrate active disease, with clinically meaningful worsening on at least one CIDP clinical assessment tool, including INCAT, I-RODS, or mean grip strength. Treatment naïve patients were able to sk...