Zai Lab Announces First Patient Dosed in Greater China in Global Registrational Clinical Trial of Efgartigimod in Primary Immune Thrombocytopenia
In a prior Phase 2 study1, patients treated with efgartigimod exhibited clinically meaningful improvement in platelet counts across doses and types of ITP patients (newly diagnosed, persistent and chronic), and this benefit strongly correlated with reduction in IgG levels. This data highlights the potency of efgartigimod in this difficult-to-treat disease. Efgartigimod has the potential to treat ITP in a novel way, targeting the disease at its source by eliminating autoantibodies and restoring platelet counts. Also, efgartigimod appears to be well tolerated, potentially because of its unique structure and ability to bind to the FcRn receptor.
ITP is a rare and often chronic bleeding disorder in which reduced numbers of platelets can lead to an increased risk of bleeding and bruising, which impairs quality of life. In ITP, the immune system produces IgG autoantibodies that destroy platelets and affect platelet production. While ITP can be asymptomatic, minor bleeding episodes are not uncommon. Some ITP patients experience more severe bleeding episodes, including intracerebral hemorrhage.
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Efgartigimod is an investigational antibody fragment designed to reduce pathogenic immunoglobulin G (IgG) antibodies by binding to the neonatal Fc receptor and blocking the IgG recycling process. Efgartigimod is being investigated in several autoimmune diseases known to be mediated by disease-causing IgG antibodies, including neuromuscular disorders, blood disorders, and skin blistering diseases. Such diseases include myasthenia gravis (MG), pemphigus vulgaris and foliaceus (PV and PF), immune thrombocytopenia (ITP), chronic inflammatory demyelinating polyneuropathy (CIDP), bullous pemphigoid, and idiopathic inflammatory myopathy (myositis).
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This press release contains statements about future expectations, plans and prospects, including, without limitation, statements regarding the possible benefits, safety and efficacy
of efgartigimod, the identification and treatment of primary immune thrombocytopenia, and risks and uncertainties associated with drug development and commercialization. These statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact nor are they guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products; (2) our ability to finance our operations and business initiatives and obtain funding for such activities, (3) the results of clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) the effects of the novel coronavirus (COVID-19) pandemic on our business and general economic, regulatory and political conditions and (6) the risk factors identified in our most recent annual or quarterly report and in other reports we have filed with the
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1 A Newland et al. Phase 2 study of efgartigimod, a novel FcRn antagonist, in adult patients with primary immune thrombocytopenia. Am J Hematol. 2020;95:178–187
Source: Zai Lab Limited