Zai Lab announces first patient dosed in Greater China in global registrational ADHERE clinical trial of efgartigimod in chronic inflammatory demyelinating polyneuropathy.

The ADHERE trial is a registrational, prospective, multi-center study to investigate the safety and efficacy of weekly subcutaneous (SC) efgartigimod in adult patients with CIDP. The trial consists of an open-label Stage A followed by a randomized, placebo-controlled Stage B. Diagnosis of CIDP will be confirmed by an independent panel of experts prior to enrollment into Stage A. In Stage B, patients are randomized to either SC efgartigimod or placebo for up to 48 weeks. The primary endpoint is event-driven and based on the adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) overall disability score.

Chronic inflammatory demyelinating polyneuropathy (CIDP) is a serious autoimmune disease of the peripheral nervous system. Although confirmation of disease pathophysiology is still emerging, there is increasing evidence that IgG antibodies play a key role in the damage to the peripheral nerves. People with CIDP experience fatigue, muscle weakness, and a loss of feeling in their arms and legs that can get worse over time or can come and go. These symptoms can significantly impair a person's ability to function in their daily lives. Without treatment, one-third of people living with CIDP will need a wheelchair.

The prevalence of CIDP in China is estimated at 50,000 patients. Current treatment options are primarily corticosteroids and intravenous immunoglobulin (IVIg). Plasmapheresis (plasma exchange) is an option when first-line therapy fails. However, there is limited access to plasmapheresis or IVIg in many parts of the world, including China. As most patients require treatment for a rather prolonged time, there remains a significant unmet need for alternate treatment options that are effective, well-tolerated, and convenient for patients with CIDP in China.