Visterra, a clinical stage biotechnology firm, has commenced a phase one clinical study of VIS649 in healthy volunteers, it was reported on Friday.
The product 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. It is an IgG2 monoclonal antibody designed and engineered using the company's Hierotope platform to target the cytokine APRIL and neutralise its biological activity.
This first-in-human phase one, randomised, placebo-controlled, double-blind, single ascending dose study is intended to evaluate the safety of the product in up to 45 healthy patients. The study will be conducted in up to five sequential dosing cohorts at escalating dose levels. Safety, pharmacokinetic and pharmacodynamic data from the initial cohorts will be evaluated. Preclinical data demonstrate the potential of VIS649 to reduce circulating IgA levels and proteinuria, while suggesting a favourable safety profile.
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