NIJMEGEN, The Netherlands–(BUSINESS WIRE)–Staten Biotechnology B.V. announced today the initiation of dosing of the Company’s lead asset, STT-5058, in a First-in-Human clinical study.
STT-5058 is a monoclonal antibody that targets the lipoprotein ApoC3 and is being developed in collaboration with Novo Nordisk. Staten Biotechnology and Novo Nordisk entered a collaboration and exclusive option agreement in December 2018 to develop novel therapeutics for the treatment of dyslipidaemia. Novo Nordisk is providing funding and support to Staten for the development of STT-5058 in this indication.
Hilde Steineger, CEO of Staten Biotechnology, said: “Staten Biotechnology, with great support from Novo Nordisk, has been able to rapidly progress from research to product manufacturing to a clinical trial for our lead drug candidate. We are very excited to dose the first healthy volunteer.”
Professor John Kastelein, Chief Medical Officer of Staten Biotechnology, added: “The commencement of the FIH trial is an important milestone for the Company. We believe STT-5058, based on its favourable safety profile and novel mechanism targeting ApoC3, which is supported by human genetics, has the potential to address an unmet medical need in patients with mixed dyslipidaemia and high cardiovascular risk.”
Notes to Editors
Staten Biotechnology B.V. aims to develop novel and innovative strategies for the treatment of dyslipidaemia, with a focus on hypertriglyceridemia treatment. BioGeneration Ventures (BGV) provided the company’s seed financing in 2014 and Forbion led the Series A round, as the sole new investor. Staten is a prime example of Forbion’s and BGV’s company building activities, growing great scientific ideas into promising companies. For further information: www.statenbiotech.com
STT-5058 is a humanized, monoclonal antibody targeting novel and unique epitopes on apoC3. This “recycling” antibody with extended half-life has the potential to lower triglyceride levels and increase clearance of ApoC3-containing atherogenic particles. Multiple studies have identified ApoC3 levels to be inversely associated with a favourable lipid profile and insulin resistance, both key components in managing residual cardiovascular risk. This antibody was licensed from Staten’s research collaboration partner argenx and is developed in collaboration with Novo Nordisk.
ApoC3 is a small apolipoprotein that inhibits the uptake of lipoprotein particles by the liver and inhibits the activity of lipoprotein lipase leading to high levels of lipoproteins and triglycerides. It is secreted from the liver and small intestine and circulates on both triglyceride-rich lipoproteins such as very-low-density-lipoproteins (VLDL), chylomicrons in addition to high-density lipoproteins. Population groups with loss-of-function mutations in apoC3 have reduced incidence of vascular and heart diseases. High levels of apoC3 correlates with higher amounts of triglycerides and increased incidence of vascular and heart disease. This supports the potential of the anti-apoC3 antibody to act as key molecule in dyslipidemia management.