Zai Lab and argenx Report Positive Topline Data from ADHERE Study of VYVGART Hytrulo in Patients with Chronic Inflammatory Demyelinating Polyneuropathy

• Study met primary endpoint (p=0.000039); VYVGART Hytrulo demonstrated 61% reduction (HR: 0.39 95% CI: 0.25; 0.61) in risk of relapse versus placebo

• IgG autoantibodies shown to play significant role in underlying CIDP disease biology
  
  
• Favorable safety and tolerability profile consistent with previous clinical trials and confirmed safety profile of VYVGART
  
  
• Zai Lab enrolled a significant number of patients in the Greater China portion of the global ADHERE study
  
  

SHANGHAI, China and CAMBRIDGE, Mass., July 17, 2023 (GLOBE NEWSWIRE) --  Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) and argenx SE (Euronext & Nasdaq: ARGX) today announced positive topline results from the ADHERE study evaluating VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) 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 ADHERE will be presented at an upcoming medical meeting.

ADHERE Highlights

• Primary 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 placebo
• 67% of patients in open-label Stage A demonstrated evidence of clinical improvement (ECI), indicating that IgG autoantibodies play a significant role in the underlying biology of CIDP
• Safety and tolerability profile consistent with confirmed safety profile of VYVGART
• 91% (226/249) of eligible patients continued to the ADHERE-Plus open-label extension study

“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,” said Dr. Chongbo Zhao, M.D., Ph.D., Deputy Director of Department of Neurology, Huashan Hospital Affiliated to Fudan University, Director of Working Group of Huashan Rare Disease Center. “Currently, intravenous immunoglobulin (IVIg), plasma exchange (PLEX), and glucocorticoids are the main treatments used during the induction and maintenance phases. However, the accessibility and convenience of IVIg and PLEX are limited, and glucocorticoids have significant side effects, leaving urgent needs for treatment options that are more effective and safe. We are excited about the therapeutic potential of VYVGART Hytrulo, a promising treatment that may become a therapeutic alternative for CIDP in China.”