Zai Lab, Argenx Report Positive Data From Trial Of VYVGART Hytrulo In CIDP

(RTTNews) - Zai Lab Ltd., a Chinese research-based, commercial-stage biopharmaceutical company, along with argenx SE (ARGX), announced Monday positive topline results from the ADHERE study of VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in patients with chronic inflammatory demyelinating polyneuropathy or CIDP.

CIDP is a rare chronic immune-mediated peripheral neuropathy characterized by weakness and sensory dysfunction in the limbs, significantly impacting the daily life and work of patients.

VYVGART Hytrulo is a subcutaneous combination of efgartigimod alfa, a human IgG1 antibody fragment marketed for intravenous use as VYVGART, and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme Therapeutics, Inc.'s (HALO) ENHANZE drug delivery technology to facilitate subcutaneous injection delivery of biologics.

The ADHERE study evaluating VYVGART Hytrulo with ENHANZE in adults with CIDP met its primary endpoint, demonstrating a significantly lower risk of relapse with VYVGART Hytrulo compared to placebo. VYVGART Hytrulo demonstrated 61% reduction in the risk of relapse versus placebo.

Safety and tolerability profile were consistent with confirmed safety profile of VYVGART. Among the eligible patients, 91% continued to the ADHERE-Plus open-label extension study.

Harald Reinhart, President and Head of Global Development, Neuroscience, Autoimmune & Infectious Diseases, Zai Lab, said, "The positive ADHERE trial data provides strong clinical evidence that VYVGART Hytrulo meaningfully improves and stabilizes disease symptoms in CIDP patients with a favorable safety profile and a simple route of administration."

Zai Lab has an exclusive license agreement with argenx for the development and commercialization of VYVGART and VYVGART Hytrulo in Greater China.

The companies will present detailed data from ADHERE at an upcoming medical meeting.

For More Such Health News, visit rttnews.com