Visterra, Inc., a clinical stage biotechnology company, today announced the initiation of a Phase 1 clinical study with VIS649 in healthy volunteers. VIS649 is a monoclonal antibody targeting the B-cell growth factor APRIL (A Proliferation Inducing Ligand) for the potential treatment of imumuglobulin A nephropathy (IgA nephropathy or IgAN), one of the most common kidney diseases other than those caused by diabetes or high blood pressure.
We are excited to initiate clinical study with VIS649, a potential therapy tailored specifically to IgA nephropathy, a kidney disease for which there are no approved therapies, said Brian J.G. Pereira, M.D., president and chief executive officer of Visterra. The current standard of care for progressive IgA nephropathy calls for use of corticosteroids, which are associated with undesirable side effects that can limit their use. A new treatment strategy with an improved benefit/risk profile would be considered a welcome addition by patients and physicians alike.
VIS649 is a first-in-class monoclonal antibody of the IgG2 subclass and was designed to target the cytokine APRIL, which we believe is an optimal target for the treatment of IgAN, said David Oldach, M.D., Visterras chief medical officer. Previously reported preclinical data in multiple animal models support clinical evaluation of VIS649 as a treatment for IgAN based on its demonstrated potential to reduce both circulating IgA levels and proteinuria, while also suggesting a favorable safety profile.
This first-in-human phase 1, randomized, placebo-controlled, double-blind, single ascending dose study will assess the safety of VIS649 in up to 45 healthy subjects. The study will be conducted in up to 5 sequential dosing cohorts at escalating dose levels. Safety, pharmacokinetic (PK) and pharmacodynamic (PD) data from the initial cohorts will be assessed.
About VIS649 VIS649 is an IgG2 monoclonal antibody designed and engineered using the companys Hierotope platform to target the cytokine APRIL (A Proliferation Inducing Ligand) and neutralize its biological activity. VIS649 is in clinical development as a potential treatment for IgA nephropathy. Preclinical data demonstrate the potential of VIS649 to reduce circulating IgA levels and proteinuria, while suggesting a favorable safety profile.
About IgA Nephropathy (IgAN) IgAN is a chronic, progressive autoimmune disease characterized by deposits of IgA immune complexes in the kidneys leading to kidney inflammation, hematuria, proteinuria and progressive kidney damage. IgAN is the most common cause of primary glomerular disease worldwide. The company estimates that each year there are approximately 3,200 new cases of kidney biopsy confirmed IgAN in the U.S. and approximately 185,000 new cases of IgAN worldwide. The prevalence of IgAN varies significantly across the globe, with an estimated incidence of up to 25 per million worldwide. It is estimated that 20 to 40% of patients with IgAN progress to kidney failure or end-stage kidney disease within 20 years of diagnosis, requiring dialysis or kidney transplantation. There are currently no therapies approved for IgAN.
About Visterra, Inc. Visterra is a clinical stage biotechnology company committed to developing innovative antibody-based therapies for the treatment of patients with kidney diseases and other hard-to-treat diseases. Its proprietary Hierotope platform enables the design and engineering of precision antibody-based product candidates that specifically bind to, and modulate, key disease targets that are not adequately addressed by traditional therapeutic approaches. The platform also includes Fc engineering capabilities for half-life extension, bispecific antibodies and antibody-drug conjugates (ADCs). Visterras pipeline includes programs targeting IgA nephropathy and other kidney diseases, cancer, chronic pain and infectious diseases. Visterra is a wholly-owned subsidiary of Otsuka America, Inc., a holding company and wholly-owned subsidiary of Otsuka Pharmaceutical Co. Ltd. of Japan. For more information about Visterra, please visit www.visterrainc.com. For more information about Otsuka, please visit https://www.otsuka.co.jp/en.
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Kathryn Morris, 914-204-6412